pharmaceutical reference standards - pmt france€¦ · 7 anatel access 643 & a643a bulk...

Pharmaceutical Reference Standards

PRA EUROPE | p. +44 (0) 161 946 2777 | f . +44 (0) 161 946 2776 | www.praeurope.com

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Dear Customers and Colleagues,

2008 marks the completion of another exciting year for PRA and the beginning of

our eighth year in business. Certainly the biggest news of 2007 for us was being

welcomed into the Waters Corporation family as an important addition to their

chemical operations division. Almost immediately PRA began taking advantage of

Waters resources that will allow us to serve our customers even better. From access to

cutting-edge technologies like our new Waters UPLC instrument, to the introduction of

six-sigma quality practices stretching across our entire company, to world-class data

management facilities, the gap between our product and service quality and that of

our competitors will be even greater.

This catalog includes many products we have added to our offerings in the past year,

some of which you may not have known we provided. Our custom products group has

a rich history in cleaning validation and analyst qualifi cation product development,

so we decided to present some of our most common custom products in this year’s

catalog for all of our customers to see. We are very proud of our custom products

group and their capabilities in pharmaceutical reference materials; if you cannot locate

a particular pharmaceutical product that you need, please call us.

At PRA we place customer satisfaction and product quality at the top of our priority

list. We are thankful to our customers, who, because of their experience with us,

have referred us to their friends and colleagues. For those of you who have not done

business with us before and have a choice of vendors for the products and services we

offer, we would be thrilled to have an opportunity to exceed your expectations and win

you as a customer.

Best regards,

The PRA Family

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5 Analytik Jena and Lachat Calibration and Validation Standards

6 Anatel Access 643 & A643a Calibration and Validation Standards

7 Anatel Access 643 & A643a Bulk Calibration and Validation Standards

8 Anatel AnaTOC Calibration and Validation Standards

9 OI Analytical Calibration and Validation Standards

10 Shimadzu Calibration and Validation Standards

11 Sievers® Models 400 and 400 ES Calibration and Validation Standards

12 Sievers® Series 800 and 900 Calibration and Validation Standards

14 Teledyne Tekmar Calibration and Validation Standards

17 Cleaning Validation Products

18 Analyst Competency Testing

20 High-Purity Water

22 Conductivity Probe Validation Kits

24 PRA Sample Vials and Containers

26 Custom PRA Products

27–31 Master TOC Standards List by Manufacturer

Contents

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We are here to help!We have customer service, manufacturing and shipping personnel here to help you from 8:00 AM

to 5:00 PM GMT. If you want the standard tomorrow, just call us by 1:00 PM GMT and you will have

your standards the next day.

We are ISO 9001 registered and comply with all applicable technical, quality and regulatory

requirements. Call +44 (0) 161 946 2777 or email us at [email protected] and we will confi rm

your order by e-mail.

Terms and ConditionsAll orders are subject to the following terms and conditions:

Confi rmationAll orders are confi rmed via FAX or email to the person placing the order.

PricingPrices within this catalog are effective January 1, 2008 and maybe subject to change without notice.

TermsTerms are Net 30 days. Freight charges are pre-paid and addedto the invoices.

Fast ShippingDue to the semi-perishable nature of the standards we manufacture, we require the product be shipped for overnight delivery. Please follow instructions to refrigerate immediately upon receipt.

SafetyPRA products may be hazardous, and are intended for use by professional laboratory personnel, trained in the competent handling of these materials. Responsibility for the safe use of PRA standards rests entirely with the user. If you need MSDS sheets, please contact us at +44 (0) 161 946 2777.

Return/Replacement PolicyPlease inspect all orders immediately upon receipt for accuracy and to ensure there was no damage in shipment. PRA will immediately correct any problem that is reported. NO OTHER WARRANTY, WHETHER EXPRESS OR IMPLIED, IS MADE WITH RESPECT TO THE PRODUCTS AND/OR SERVICES. PRA EXPRESSLY EXCLUDES THE IMPLIED WARRANTIES OF MERCHANTABILITY AND OF FITNESS FOR A PARTICULAR PURPOSE. PRA SHALL NOT BE LIABLE FOR CONSEQUENTIAL, INCIDENTAL, SPECIAL OR ANY OTHER INDIRECT DAMAGES RESULTING FROM ECONOMIC LOSS OR PROPERTY DAMAGE SUSTAINED BY BUYER FROM THE USE OF ITS PRODUCTS.

Customer Care

Graham RoscoeManaging Director

Debbie RoscoeProduction Chemist

Caroline HydeProduction Technician

Curtis WoodDirector, Business Development and Regulatory Affairs

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Analytik Jena are leaders in the development of reliable composite parameter and elemental

systems designed to satisfy the diverse modern demands of today’s laboratory. PRA carries a number

of validation and calibration sets for AJ Total Organic Carbon instruments.

USP System Suitability Set (40 mL)Set includes (1) Reagent Water RW, (1) USP Sucrose

RS (0.500 ppm), and (1) USP 1,4-benzoquinone RSS

(0.500 ppm).

Cat # 18000 HCl-preserved for AJ multi N/C pharma HSCat # 18004 H3PO4-preserved for AJ multi N/C UV HS

USP System Suitability Set (250 mL)Set includes (1) Reagent Water RW, (1) USP Sucrose


(0.500 ppm).


TOC Calibration Kit (Full) (250 mL)Set includes eight 250 mL amber bottles, (1) Water

blank, (1) 1.00 ppm NIST KHP, (1) 2.50 ppm NIST

KHP, (1) 5.00 ppm NIST KHP, (1) 10.0 ppm NIST KHP,

(1) 25 ppm NIST KHP, (1) 50.0 ppm NIST KHP, (1) 100

ppm NIST KHP.

Cat # 19970 HCl-preserved for AJ multi N/C 2100/3100Cat # 19971 H3PO4-preserved for AJ N/C UV HS

TOC Calibration Kit (Limited) (40 mL)Set includes (1) Reagent Water Blank, (1) USP

Sucrose (0.600 ppm).


TOC Calibration Kit (Limited) (250 mL)Set includes (1) Reagent Water Blank, (1) USP

Sucrose (0.600 ppm).


Cleaning Validation Kit (Full) (40 mL)Set includes fi ve 40 mL vials, (1) Water blank, (1)

0.250 ppm NIST Sucrose, (1) 0.500 ppm NIST

Sucrose, (1) 0.750 ppm NIST Sucrose, (1) 1.00 ppm

NIST Sucrose.


Cleaning Validation Kit (Full) (250 mL)Set includes fi ve 250 mL amber bottles, (1) Water

blank, (1) 0.250 ppm NIST Sucrose, (1) 0.500 ppm

NIST Sucrose, (1) 0.750 ppm NIST Sucrose, (1) 1.00

ppm NIST Sucrose.


Sample Vials40 mL Low TOC vials (80/cs)Cat. #25025 Scrupulously cleaned Low TOC vials for all TOC

sample analyses.

See page 24 for more information on PRA vials.

Analytik JenaCalibration and Validation Standards

Analytic Jena multi N/C pharma HS

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A 643 Calibration KitCat. #19200 Set includes fi ve vials, (2) Blanks, (1) 0.250 ppm


ppm NIST Sucrose

A 643 Validation KitCat. #19210 Set includes ten vials, (2) Blanks, (1) 0.250 ppm NIST

Sucrose, (1) 0.500 ppm NIST Sucrose, (1) 0.750 ppm

NIST Sucrose, (1) 100 mS/cm Conductivity

Std., (1) USP System Suitability Set.

A 643 Validation Control KitCat. #19220 Set includes three vials, (2) Blanks, (1) 0.500 ppm

NIST Sucrose.

A 643 Validation Protocol KitCat. #19230 Set includes 38 vials, (10) Blanks, (3) 0.250 ppm


ppm NIST Sucrose, (1) 100 µS/cm Conductivity

Std., (4) USP System Suitability Sets.

Conductivity Solution KitCat. #02610 Set includes one vial of 100 µS/cm KCI in water for

calibrating conductivity probe on Anatel A 643.

Individual Standards for the A 643Cat. #13300 Calibration Blank Cat. #13400 0.250 ppm NIST Sucrose Cat. #13500 0.500 ppm NIST Sucrose Cat. #13600 0.750 ppm NIST Sucrose Cat. #02610 100 µS/cm Conductivity Solution Kit

USP System Suitability SetCat. #18400 Set includes (2) Reagent Waters RW, (1) 0.500

ppm USP Sucrose RS, and (1) 0.500 ppm USP 1,4-

benzoquinone RSS.

Low TOC Sample Vial KitCat. #25045 Set includes one case of 68 pre-cleaned Low TOC

vials, 50 mL with pre-cleaned septa and aluminum

crimp cap. Use for grab samples to be analyzed on

Anatel A 643.

Please see page 27 or contact PRA for additional concentrations and volumes.

Anatel Access 643 & A643aCalibration and Validation Standards

PRA provides a complete line of standards designed for use with the Anatel 643 TOC analyzers.

The standards for these instruments are prepared using a carefully controlled process to remove

ionic contamination as well as TOC contamination from the entire system. The standards have a 30

day expiration and are guaranteed to meet the quality specifi cations throughout the entire 30 days.

All PRA standards are available in larger bulk packaged volumes. Customers who have used PRA’s

bulk packaged standards rate them superior in stability and accuracy to other vendor’s individually

packaged standards. If you are familiar with individual use standards and would like to try the bulk

packaged standards, please call us.Anatel Access A643a

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These PRA sucrose standards are used for calibration and validation of Anatel on-line TOC analyzers. PRA sucrose

standards are offered in ready-to-use containers (60 mL) for use with the Anatel Access 643 & 643a instruments.

We also package these standards in larger poly containers for pour off and use in multiple applications.

Anatel Access 643 & A643aBulk Calibration and Validation Standards

Bulk Packaged Standards forAccess 643 & 643a

125 mL Unpreserved TOC Calibration StandardsCat. #10019 Calibration Blank Cat. #10319 0.250 ppm NIST Sucrose Cat. #10619 0.500 ppm NIST Sucrose Cat. #10919 0.750 ppm NIST Sucrose Cat. #02600 100 µS/cm Conductivity Calibration Standard



USP System Suitability Sets Bulk Package for the Anatel A 643Cat. #18035 125 mL Cat. #18060 250 mL Cat. #18150 500 mL Cat. #18245 1 L

Call PRA for model TOC 600 Calibration andValidation standards.

Sample Bottles60 mL Low TOC bottlesCat. #25030 60 mL HDPE Bottle for A-643 (natural) Cat. #25033 60 mL HDPE Bottle for A-643 (amber)

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AnaTOC Validation SetCat. #19100 Set includes six bottles, (1) 250 mL TOC Blank, (1)

125 mL 0.500 ppm KHP, (1) 250 mL 1.00 ppm KHP,

(1) 125 mL USP System Suitability Set (one each:

Reagent Water RW, USP Sucrose RS (0.500 ppm), and

USP 1,4-benzoquinone RSS (0.500 ppm)).

AnaTOC Standards

125 mL Preserved TOC Calibration StandardsCat. #10015 TOC Water Blank Cat. #11720 0.250 ppm NIST KHP Cat. #11730 0.500 ppm NIST KHP Cat. #11810 1.00 ppm NIST KHP Cat. #18025 USP System Suitability Set

250 mL Preserved TOC Calibration StandardsCat. #10025 TOC Water Blank Cat. #11721 0.250 ppm NIST KHP Cat. #11735 0.500 ppm NIST KHP Cat. #11820 1.00 ppm NIST KHP Cat. #18050 USP System Suitability Set

500 mL Preserved TOC Calibration StandardsCat. #10100 TOC Water Blank Cat. #11722 0.250 ppm NIST KHP Cat. #11750 0.500 ppm NIST KHP Cat. #11900 1.00 ppm NIST KHP Cat. #13299 1000 ppm NIST KHP Cat. #18100 USP System Suitability Set

Individual Calibration and Validation Standards for A-1000Cat. #10211 Calibration Blank (1 L) Cat. #10511 0.250 ppm NIST Sucrose (1 L) Cat. #10811 0.500 ppm NIST Sucrose (1 L) Cat. #11111 0.750 ppm NIST Sucrose (1 L) Cat. #19030 USP System Suitability Set


sample analyses.


Anatel AnaTOC Calibration and Validation Standards

All AnaTOC TOC standards are preserved and have an extended (6-month) expiration. We provide

these standards in several volumes so you can purchase precisely what you will use.

Anatel Access 1000

Anatel AnaTOCAnatel AnaTOC

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Individual Standards for Calibration or Verifi cationCat. #10001 TOC/IC Calibration Blank 40 mL Cat. #10016 TOC/IC Calibration Blank 125 mL Cat. #11726 0.500 ppm from NIST KHP 40 mL Cat. #11731 0.500 ppm from NIST KHP 125 mL Cat. #11801 1.00 ppm from NIST KHP 40 mL Cat. #11811 1.00 ppm from NIST KHP 125 mL Cat. #12401 5.00 ppm from NIST KHP 40 mL Cat. #12411 5.00 ppm from NIST KHP 125 mL Cat. #12701 10.0 ppm from NIST KHP 40 mL Cat. #12711 10.0 ppm from NIST KHP 125 mL Cat. #13001 25.0 ppm from NIST KHP 40 mL Cat. #13021 25.0 ppm from NIST KHP 125 mL Cat. #13224 50.0 ppm from NIST KHP 40 mL Cat. #13227 50.0 ppm from NIST KHP 125 mL Cat. #18006 RW-Reagent Water USP 40 mL Cat. #18007 RS-0.500 ppm from USP Sucrose RS 40 mLCat. #18008 RSS-0.500 ppm from USP Benzoquinone 40 mLCat. #18029 RW-Reagent Water USP 125 mL Cat. #18031 RS-0.500 ppm from USP Sucrose RS 125 mLCat. #18032 RSS-0.500 ppm from USP Benzoquinone 125 mL

Please see page 30 or contact PRA for additional concentrations and volumes.

OI Analytical TOC Validation Set–Aurora Cat. #19007 Set includes nineteen 40 mL vials, (6) Water blank,

(1) 0.500 ppm NIST KHP, (3) 1.00 ppm NIST KHP, (1)

5.00 ppm NIST KHP, (1) 10.0 ppm NIST KHP, (1) 25.0

ppm NIST KHP, (1) 5.00 ppm NIST KHP/50.0 ppm

NaHCO3, (4) 0.500 ppm from USP Sucrose,

(1) 0.500 ppm from USP 1,4-benzoquinone.

Ultra Low-Level TOC Standards Kit Cat. #14203 Set includes twelve 40 mL vials, (3) TOC Water

Blanks, (1) each of 0.05, 0.06, 0.07, 0.08, 0.09, 0.100,

0.250, 0.500 and 1.00 ppm from NIST KHP.

USP System Suitability Set (40 mL)Cat. #18004 Set includes one each: Reagent Water RW, USP

Sucrose RS (0.500 ppm), and USP 1,4-benzoquinone

RSS (0.500 ppm).

Bulk Preserved USP System Suitability SetsThese standards come preserved and packaged in

ultra-clean amber bottles for use with OI Analytical

TOC analyzers. Each standard has a 6-month

expiration period from the day it is shipped.

Cat. #18024 125 mL Cat. #18049 250 mL Cat. #18104 500 mL Cat. #18204 1 L


sample analyses.


OI Analytical TOC analyzers have been used in critical applications requiring

ultra-low carbon analysis since 1984. For OI Analytical TOC instrument

validation, calibration and system suitability, PRA recommends using only

preserved TOC standards to meet USP <643> criteria for pharmaceutical

water quality monitoring.

The products below are commonly purchased for use with OI Analytical

TOC instruments.

OI Analytical Calibration and Validation Standards

OI Aurora

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Individual Standards for Calibration or Verifi cationCat. #10000 TOC/IC Calibration Blank 40 mL Cat. #10015 TOC/IC Calibration Blank 125 mL Cat. #11725 0.500 ppm from NIST KHP 40 mL Cat. #11730 0.500 ppm from NIST KHP 125 mL Cat. #11800 1.00 ppm from NIST KHP 40 mL Cat. #11810 1.00 ppm from NIST KHP 125 mL Cat. #12400 5.00 ppm from NIST KHP 40 mL Cat. #12410 5.00 ppm from NIST KHP 125 mL Cat. #12700 10.0 ppm from NIST KHP 40 mL Cat. #12710 10.0 ppm from NIST KHP 125 mL Cat. #13000 25.0 ppm from NIST KHP 40 mL Cat. #13020 25.0 ppm from NIST KHP 125 mL Cat. #13225 50.0 ppm from NIST KHP 40 mL Cat. #13226 50.0 ppm from NIST KHP 125 mL Cat. #18000 USP System Suitability Set 40 mL Cat. #18001 RW-Reagent Water USP 40 mL Cat. #18002 RS-0.500 ppm from USP Sucrose RS 40 mLCat. #18003 RSS-0.500 ppm from USP Benzoquinone 40 mLCat. #18026 RW-Reagent Water USP 125 mL Cat. #18027 RS-0.500 ppm from USP Sucrose RS 125 mLCat. #18028 RSS-0.500 ppm from USP Benzoquinone 125 mL

See page 29 or contact PRA for additional concentrations and volumes.

USP System Suitability Set (40 mL)Cat. #18000 Set includes (1) Reagent Water RW, (1) USP Sucrose


(0.500 ppm).

Bulk Preserved USP System Suitability SetsThese standards come preserved and packaged

in ultra-clean amber bottles for use with Shimadzu

TOC analyzers. Each standard has a 6-month



Ultra Low-Level TOC Standards Kit Cat. #14200 Set includes twelve 40 mL vials, (3) TOC Water

Blanks, (1) each of 0.05, 0.06, 0.07, 0.08, 0.09, 0.100,



sample analyses.


Shimadzu Calibration and Validation Standards

Shimadzu is a brand familiar to laboratory instrumentation users and a company with a rich history

in TOC analysis. We recommend using only preserved standards for calibration, validation and

system suitability as required by USP <643>.

The products below are commonly purchased for use with Shimadzu instruments.

Shimadzu TOC–VWs

Shimadzu TOC–TCs

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Individual Use Standards

30 mL TOC Calibration StandardsCat. #13700 Calibration Blank Cat. #14100 1.25 ppm NIST Sucrose Calibration StandardCat. #02700 25 µS/cm Conductivity Calibration Standard

Bulk Packaged Standards




Sample Vials30 mL poly vial for Sievers® Model 400Cat. #25015


USP System Suitability SetSet includes (1) Reagent Water RW, (1) USP Sucrose


(0.500 ppm).

Cat. #18300 30 mL Cat. #18030 125 mL Cat. #18055 250 mL Cat. #18140 500 mL

Replacement UV LampsCat. #20040 Replacement UV Lamp for Sievers® Model 400Cat. #20045 Replacement UV Lamp for Sievers® Model 500

Miscellaneous Replacement PartsCat. #20035 60 Micron in-line Stainless Filter Cat. #25040 Fan fi lter for Sievers® Model 400 and 800Cat. #20055 Replacement pump-tubing for Sievers® Model 400

The Sievers® Model 400 and 400 ES analyzers are similar to their bench top models with the

important distinction that the analyzer cannot be subjected to ionic chemicals. It is for this reason

that PRA manufactures standards for these instruments using a distinctly different process. In

addition the containers used for storage, transportation and introduction of these standards are all

plastic to make certain no extra ions are introduced to the instrument from a glass container. We

also package these standards in larger poly containers for pour off and use in multiple applications.

Sievers® Models 400 & 400 esCalibration and Validation Standards

Sievers® 400 ES

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Sievers® Model 900 Multi-PointCalibration Set (40 mL)Catalog # 19610 Set includes eleven vials, (1) blank, (1) each of 1, 5,

10, 25 and 50 ppm KHP, (1) each of 1, 5, 10, 25 and

50 ppm NaHCO3. Replaces Sievers® Part STD 90000.

Sievers® Model 900 Autoreagents Calibration Set (40 mL)Catalog # 19611 Set includes four vials, (1) blank, (1) 25.0 ppm

KHP, (1) 25 ppm NaHCO3, (1) 50 ppm C6H5NO2

(Nicotinamide). Replaces Sievers® Part STD 90036.

USP System Suitability Set (40 mL)Cat. #18000 Set includes (1) Reagent Water RW, (1) USP Sucrose


(0.500 ppm). Replaces Sievers® Part STD 31004.

Ultra Low-Level TOC Standards KitCat. #14200 Set includes twelve 40 mL vials, (3) TOC Water

Blanks, (1) each of 0.05, 0.06, 0.07, 0.08, 0.09, 0.100,


Sievers® Model 800 AutosamplerCalibration Set (40 mL)Cat. #19500 Set includes twelve vials, (4) blanks, (4) 25 ppm KHP, (4)


Please see page 29 for individual standards.

Sievers® Model 800 Grab ModeCalibration Set (40 mL)Cat. #19510 Set includes six vials, (2) blanks, (2) 25 ppm KHP, (2)


Sievers® 800 and 900 Linearity Set (40 mL)Cat. #19515 Set includes four vials, (1) blank, (1) 250 ppb KHP,

(1) 500 ppb KHP, (1) 750 ppb KHP. Replaces Sievers®

Part STD 31012.

Sievers® Model 800 Low LevelValidation Set (40 mL)Cat. #19520 Set includes 37 vials, (10) blanks, (4) 25 ppm KHP,

(4) 25 ppm NaHCO3 , (2) 250 ppb KHP, (9) 500 ppb

KHP, (2) 750 ppb KHP, and (2) USP System Suitability

Sets. Replaces Sievers Part STD 38101.


in ultra-clean amber bottles for use with Sievers®

Model 800 and 900 TOC analyzers. Each standard

has a 6-month expiration period from the day it

is shipped.


PRA prepares a complete list of calibration and validation standards for use with the Sievers®

brand of laboratory TOC analyzers. The standards can be used for any calibration or validation

application found in the Sievers® literature. If you want a specifi c “kit” or standard supplied to

you at periodic intervals, just tell us what you want and when you want them, and we’ll take

care of the rest.

Try PRA for use with your Sievers® instrument today. We guarantee our products unconditionally.

Sievers® Series 800 and 900Calibration and Validation Standards

Sievers® Model 900

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ReagentsCat. #21000 150 mL H3PO4 Reagent Cartridge for Sievers® 800Cat. #21010 150 mL H3PO4 Reagent Cartridge for Sievers® 900Cat. #21005 150 mL (NH4)2S2O8 Reagent Cartridge for Sievers® 800Cat. #21015 150 mL (NH4)2S2O8 Reagent Cartridge for Sievers® 900


sample analyses.


Replacement UV LampsCat. #20040 Replacement UV Lamp for Sievers® Model 800Cat. #20045 Replacement UV Lamp for Sievers® Model 900

Miscellaneous Replacement PartsCat. #20035 60 Micron in-line Stainless Filter Cat. #25040 Fan fi lter for Sievers® Models 400 and 800Cat. #20050 Replacement tubing for Sievers® 800

Did you know?The Oxidizable Substance Test was introduced by the

USP in 1890. The Chapter <643> TOC method was

introduced in the USP 23 Fifth Supplement in May

1997. The Oxidizable Substance Test was deleted from

the 8th Supplement in May 1998.

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Individual Standards for Calibration or Verifi cationCat. #10001 TOC/IC Calibration Blank 40 mL Cat. #10016 TOC/IC Calibration Blank 125 mL Cat. #11726 0.500 ppm from NIST KHP 40 mL Cat. #11731 0.500 ppm from NIST KHP 125 mL Cat. #11801 1.00 ppm from NIST KHP 40 mL Cat. #11811 1.00 ppm from NIST KHP 125 mL Cat. #12401 5.00 ppm from NIST KHP 40 mL Cat. #12411 5.00 ppm from NIST KHP 125 mL Cat. #12701 10.0 ppm from NIST KHP 40 mL Cat. #12711 10.0 ppm from NIST KHP 125 mL Cat. #13001 25.0 ppm from NIST KHP 40 mL Cat. #13021 25.0 ppm from NIST KHP 125 mL Cat. #13224 50.0 ppm from NIST KHP 40 mL Cat. #13227 50.0 ppm from NIST KHP 125 mL Cat. #18006 RW-Reagent Water USP 40 mL Cat. #18007 RS-0.500 ppm from USP Sucrose RS 40 mLCat. #18008 RSS-0.500 ppm from USP Benzoquinone 40 mLCat. #18024 USP System Suitability Set 125 mL Cat. #18029 RW-Reagent Water USP 125 mL Cat. #18031 RS-0.500 ppm from USP Sucrose RS 125 mLCat. #18032 RSS-0.500 ppm from USP Benzoquinone 125 mL

Please see pages 30-31 for additional concentrations and volumes.

USP System Suitability Set (40 mL)Cat. #18004 Set includes Reagent Water RW, USP Sucrose

RS (0.500 ppm), and USP 1,4-benzoquinone

RSS (0.500 ppm).

Teledyne Tekmar Validation Set–PhoenixCat. #19002 Set includes eighteen 40 mL vials, (2) Blanks, (3)


ppm NIST KHP, (1) 5.00 ppm NIST KHP, (1) 50.0 ppm

NIST KHP, (1) 100 ppm NaHCO3, (1) USP System

Suitability Set (one water blank RW, one 0.500 ppm

from USP Sucrose RS, one 0.500 ppm from USP 1,4-

benzoquinone RSS).

Teledyne Tekmar Validation Set–FusionCat. #19004 Set includes eleven 40 mL vials and one 125 mL

bottle, (3) Blanks, (3) 1.00 ppm NIST KHP, (1) 125 mL


ppm NaHCO3, (1) USP System Suitability Set (one

water blank RW, one 0.500 ppm from USP Sucrose RS,

one 0.500 ppm from USP 1,4-benzoquinone RSS).

Ultra Low-Level TOC Standards KitCat. #14203 Set includes twelve vials, (3) blanks, (1) each of 0.05,

0.06, 0.07, 0.08, 0.09, 0.100, 0.250, 0.500 and 1.00

ppm from NIST KHP.

Tekmar has been a pioneer in the TOC business for more than 35 years, and PRA is pleased

to offer a full range of standards and reagents for use with your DC-180, DC-190, Phoenix,

Apollo or Fusion. For Tekmar TOC instrument validation, calibration and system suitability, PRA

recommends using only preserved TOC standards to meet USP <643> criteria for pharmaceutical

water quality monitoring.

The products below are commonly purchased for use with Tekmar instruments.

Teledyne TekmarCalibration and Validation Standards

Teledyne Tekmar Fusion

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in ultra-clean amber bottles for use with Teledyne

Tekmar TOC analyzers. Each standard has a 6-month




sample analyses.


ReagentsKey to accurate low-level analyses on

pharmaceutical waters is keeping the overall

instrument background (TOC contribution from the

“system”) as low as possible. PRA offers acid and

persulfate reagents specifi cally for Teledyne Tekmar

TOC systems that are manufactured with only the

highest purity chemicals and ultra-clean containers.

The care we take ensures the lowest possible

contribution of background TOC from the reagents.

• 10% Ammonium Persulfate

((NH4)2S2O8) Reagent

• 15% Phosphoric Acid (H3PO4) Reagent

PRA offers 1 L pre-made reagents for Teledyne

Tekmar and OI Analytical TOC instruments as

well as reagent prep kits with pre-measured ultra

phosphoric acid and ammonium persulfate that

can easily be diluted to volume in your containers

or ours.

Please call PRA for more information or to order reagents for your Teledyne Tekmar or OI Analytical TOC.

16


PRA Standards Traceability

We understand the criticality of conformity

and traceability in the pharmaceutical

industry when utilizing analytical standards

and reference materials as it relates to the

data quality infrastructure of our customers.

Documented traceability is one critical part of

the process to generate defensible analytical

data. It creates rational levels of confi dence

in data generated and allows for vigorous

support of analytical data in your lab today

and in the future. As would be expected in

a cGMP environment, all of PRA’s standards

are accompanied by a Certifi cate of Analysis

(C of A) that includes important criteria

such as a material’s intended use, method

of preparation, certifi ed value and relative

measurement uncertainty.

the process to generate defensible analytical

data. It creates rational levels of confi dence

in data generated and allows for vigorous

of preparation, certifi ed value and relative

measurement uncertainty.

17


Cleaning Validation Sampling KitsCat. #CV10000 Vial and Swab Sampling Kit

28 certifi ed clean swabs14 certifi ed clean vials

Cat. #CV10005 Vial and Swab Sampling Kit 175 certifi ed clean swabs80 certifi ed clean vials

Cleaning Validation CouponsSpecial Order Coupons Coupons of any size, material or swabbing area

(metals, plastics, rubbers). Certifi cates of analysis

for materials traceability, fi nish and cleanliness.

Visually Clean Training CouponsSpecial Order Organoleptic Coupons Proprietary formulation soils bracketing your

MAC limits for use as visually clean indicators.

Cleaning Validation Kits for Recovery Studies and Analyst TrainingCustom Cleaning Validation Kit

• Protocols for Swabbing Validation

• Six coupons in the material of your choice (Steel,

Aluminum, Titanium, Rubbers, Plastic Polymers–3"

x 6" or 6" x 6" cleaned coupons, etched with four

25 cm2 spiking areas—metals).

• 3-6 Sucrose-spiked coupons per your

specifi cations

• 3-6 API-spiked coupons per your specifi cations

• Certifi cates of analysis for materials traceability

and cleanliness (TOC)

• 24 Certifi ed Low TOC Vials

• 100 Certifi ed Low TOC Swabs

• 6 Pairs Powder-free Nitrile Gloves

• 1 set of linearity standards appropriate for

your working range

Options• Validation documentation for swabbing development

• Residue method development services

• Coupons soiled with unknown compounds

for swabbing and qualifi cation training

• Coupons soiled with proprietary customer

formulations (compounds and concentrations

can be selected by PRA or your experts)

• Performance evaluations and training certifi cates

available in conjunction with blind sample kit options

PRA is the premier manufacturer of HPLC and TOC cleaning validation coupons and kits, providing

certifi ed clean vials, swabs and coupons that can be customized to suit your laboratory, analyst

and validation needs. We have been the leading provider of proprietary formulation services for

cleaning validation for more than 7 years, offering surface soiling services for rinse, swab and

organoleptic cleaning validation schema.

Cleaning Validation Products

”

“While it is understood that rinse samples are capable of sampling larger surface areas, particularly ones which are diffi cult to access, for the purposes of cleaning validation, rinse samples alone would not be acceptable unless a direct measurement of the residue or contaminant has been made.

Human DrugcGMP NotesVol. 6, No. 4December 1998

s.

18


Water Quality Testing

WQT–Total Organic CarbonCat. #A013 Contains one 60 mL water sample containing Total

Organic Carbon in the range of 0.10 to 5.0 mg/L.

WQT–ConductivityCat. #A014 Contains one 250 mL water sample with a

Conductivity value in the range of 25 to 250 µS/cm.

WQT–Total and Fecal ColiformCat. #A010 Designed to the specifi cations of USP Chapter

<1231>. Contains three lyophilized samples to be

analyzed for presence, absence and/or enumeration

of total and fecal coliforms. Each sample is provided

with one 99 mL phosphate-buffered dilution water

for re-hydration of the lyophilized sample. The

organisms present in each sample will be selected

from the following list:

Escherichia coli.

Enterobacter cloacae

Pseudomonas aeruginosa

Proteus vulgaris

Blank

WQT–Fecal StreptococcusCat. #A011 Designed to the specifi cations of USP Chapter

<1231>. Contains one lyophilized sample to be

analyzed for presence, absence and/or enumeration

of fecal streptococcus or Enterococci. Each

sample is provided with one 99 mL phosphate-

buffered dilution water for re-hydration of the

lyophilized sample.

WQT–Isolate Identifi cationCat. #A012 Designed to the specifi cations of USP Chapter

<1231>. Contains one lyophilized sample to be

identifi ed for one of the Genera listed below. Each

sample is provided with one 99 mL phosphate-

buffered dilution water for re-hydration of the

lyophilized sample.

Brevundimonas Burkholderia

Chromobacterium Enterococcus

Erysipelothrix Klebsiella

Kocuria Methylobacterium

Micrococcus Morganella

Pseudomonas Pseudonocardia

Ralstonia Shewanella

Sphingomonas Stenotrophomonas

Yersinia

It is an FDA requirement for pharmaceutical laboratories to demonstrate adequacy of training

for all laboratory personnel. Although it is not a requirement for each analyst to perform “blind”

sample analysis (analysis of unknowns), FDA regulators agree that it is the most defensible

argument for completeness of training and analyst competency. PRA is pleased to offer a suite

of standard catalog tests for analyst competency as well as a custom products group capable of

developing and administering blind sample analysis for virtually any analytical requirement you

have. PRA provides the sample to the laboratory (or specifi c analyst) complete with instructions for

analysis and data submission. Upon successful analysis, PRA issues a certifi cate of competency.

Analyst Competency Testing

19


Microbial Limit TestingCat. #(See Below) Designed to the specifi cations of USP Chapter <61>. Each

set contains quantitative lyophilized samples to be tested for

the analytes listed below. Each set is provided with one 99

mL phosphate-buffered dilution water for re-hydration of the

lyophilized samples.

Cat. # Analytes

A001 Staphylococcus aureusTotal aerobic microbial countTotal and combined molds and yeast

A002 Escherichia coli.Bile-tolerant and Gram-negative bacilliTotal aerobic microbial count

A003 Pseudomonas aeruginosaBile-tolerant and Gram-negative bacilliTotal aerobic microbial count

A004 Salmonella speciesEscherichia coli.

Bile-tolerant and Gram-negative bacilliA005 Clostridium species

Salmonella species Total aerobic microbial countA006 Candida albicans Total and combined molds and yeast Total aerobic microbial count

Antimicrobial Effectiveness TestingCat. #A007 Designed to the specifi cations of USP Chapter <51>. Each set

contains quantitative lyophilized samples to be tested for the

organisms listed below. Each set is provided with fi ve

phosphate-buffered dilution waters for re-hydration of the

lyophilized samples.

Escherichia coli.

Staphylococcus aureus.

Pseudomonas aeruginosa

Candida albicans

Aspergillus niger

Environmental Monitoring Isolate Identifi cation

EMII–FungusCat. #A009 Designed to the specifi cations of USP Chapter <1231>. Consists of

one KWIK-STIK™ sample containing one fungus from the list below.

Absidia Acremonium Alternaria

Aspergillus Asteromyces Beauveria

Chryosporium Cladiosporium Cunninghamella

Geotrichum Glioccladium Microsphaeropsis

Paecilomyces Penicillium Rhizipus

Scopulariopsis Sepedonium Sodaria

Sporobolomyces Syncephalostrum Trichoderma

Trichophyton Verticillum Wallerni

EMII–BacteriumCat. #A008 Designed to the specifi cations of USP Chapter <1231>. Consists

of one KWIK-STIK™ sample containing one bacterium from the

list below:

Aerococcus Bacillus Brevundimonas

Budvica Burkholderia Citrobacter

Corynebacterium Delftia Edwardsiella

Enterococcus Erysipelothrix Klebsiella

Kocuria Lactococcus Leciercia

Listeria Methylobacterium Micrococcus

Moraxella Morganella Mycobacterium

Nocardia Oligella Paenibacillus

Proteus Providencia Pseudomonas

Ralstonia Shewanella Sphingomonas

Staphylococcus Stenotrophomonas Streptococcus

Yersinia

20


High-Purity Water

PRA offers high-purity water suitable for use with your total organic carbon or liquid chromatography

system. All PRA waters are prepared with the highest level of care throughout the Ion-Exchange-

Filtration-RO-UV purifi cation process. Our waters must pass a rigorous testing scheme, and we

guarantee the analysis of each bottle as well as your satisfaction.

USP Purifi ed–Certifi ed Low TOC WaterCat. #PW10000 USP purifi ed Low TOC Water 4L Cat. #PW10005 USP purifi ed Low TOC Water 4 x 4L case

Guaranteed Specifi cations: pH . . . . . . . . . . . . . . . . . . . . . 5-7

Residue after Evaporation . . 1 ppm max.

Conductivity (at Bottling) . . 1.0 µS/cm max @ 20ºC

Total Organic Carbon . . . . . . 50 ppb max.

Total Bacterial Count . . . . . . < 10 cfu/mL

Color (APHA) . . . . . . . . . . . . 5 max.

Did you know?Total Organic Carbon (TOC) chapter <643> of the

USP water monographs is targeted for revision in 2008

as it relates to Process Analytical Technology (PAT)

considerations. Watch for proposed revisions from the

USP Pharmaceutical Water Expert Committee.

PRA Product Stability

When it comes to standards in the

pharmaceutical laboratory, quality,

consistency and stability are essential.

The analytical thoroughness applied to

every step of our manufacturing process

ensures that each of PRA’s products will

meet even the strictest expectations for

quality. If it doesn’t meet our quality

requirements it doesn’t leave the building.

The stability studies that have been

performed on each of our products

ensure that the quality specifi cations

they were designed and manufactured

to will be maintained throughout the

shipping process to your laboratory.

Our goal is to deliver our products with

the longest possible expiry dates when

handled as indicated in the instructions

you receive with each package. Expiry

periods range from 30-180 days and have

been confi dently assigned after our tiring

efforts to prove product stability.

22


Conductivity Probe Validation Kits

Validating the detection limits, accuracy and precision of a conductivity sensor in ultrapure water

has been very elusive using traditional calibration solution schemes. Therefore, PRA is offering a

three solution Validation Kit that will allow an accurate, verifi able, and FDA approved approach to

validating the sensor for your USP <645> methods. The kits come in single-use 125 mL volumes as

well as multi-use 500 mL bottles. Each Validation Kit consists of three (3) conductivity calibration

solutions. Measurements are made at each level and the results used to determine the Method

Detection Limit (MDL), Limit of Detection (LOD) and Limit of Quantitation (LOQ). In addition, the

data are used to verify probe accuracy and linearity. For a complete explanation of how to use

the conductivity Probe Validation Kits, please call and request one of several application notes

available from PRA.

Did you know? Conductivity chapter

<645> of the USP

water monographs is

targeted for revision

proposals in 2008 as the

signifi cance of Process

Analytical Technology

(PAT) expands.

Watch for proposed

revisions from the USP

Pharmaceutical Water

Expert Committee.

23


Individual Use 125 mLConductivity Validation KitCat. #02850 Kit Includes three bottles, (1) 25 µS/cm HCl in Water,

(1) 100 µS/cm KCl in Water, and (1) 146.93 µS/cm

KCl in Water.

Multiple Use 500 mLConductivity Validation KitCat. #02900 Kit Includes three bottles, (1) 25 µS/cm HCl in Water,

(1) 100 µS/cm KCl in Water, and (1) 146.93 µS/cm

KCl in Water.

Individual Low-Level Conductivity Standard 25 µS/cm HCl in WaterPRA’s Solution 25 is the lowest level, stable

conductivity solution available in water. Other

low-level conductivity solutions are made from

alcohol-water mixtures. This solution is an excellent

verifi cation solution once you have calibrated

your cell using Solution D. This standard can

verify that the accuracy of your cell meets the USP

requirements and will positively demonstrate and

document that you are using non-compensated

conductivity measurements as required.

Cat. #01200 1 L Solution 25 at 25 µS/cm Cat. #01300 500 mL Solution 25 at 25 µS/cm Cat. #01400 125 mL Solution 25 at 25 µS/cm Cat. #02700 Sievers® Model 400 25 µS/cm Conductivity Calibration Standard Replaces Sievers Part STD 30030Cat. #02000 125 mL Wide Mouth Pre-cleaned HDPE containers for measuring calibration solutions. Cat. #01000 1 L Solution 25 Test Kit Includes Solution 25 and 10 pre-cleaned 125 mL containers.Cat. #01100 500 mL Solution 25 test Kit Includes Solution 25 and 5 pre-cleaned 125 mL containers.

Individual Mid-Level Conductivity Standard100 µS/cm KCl in WaterManufactured using NIST traceable materials and

certifi ed, this KCl solution is an excellent calibration

or calibration verifi cation solution. This solution is

certifi ed by analysis and does not require the use of a

reference blank for accurate calibration or validation.

Cat. #02400 1 L of Solution 100 at 100 µS/cm Cat. #02500 500 mL of Solution 100 at 100 µS/cm Cat. #02600 125 mL of Solution 100 at 100 µS/cm Cat. #02610 Anatel Model A-643 Conductivity Calibration Standard – 60 mLCat. #02200 1 L Solution 100 test Kit Includes Solution 100 and 10 pre-cleaned 125 mL containers.Cat. #02300 500 mL Solution 100 test Kit Includes Solution 100 and 5 pre-cleaned 125 mL containers.Cat. #02000 125 mL Wide Mouth Pre-cleaned HDPE containers for measuring calibration solutions.

Individual Mid-Level Conductivity Standard146.93 µS/cm KCl in WaterManufactured according to the ASTM 1125 Test

Method for conductivity and conductivity calibration.

This solution is the lowest level solution that can

be made following a NIST protocol for conductivity

solution preparations. This standard makes an

excellent calibration or verifi cation solution together

with PRA’s Solution 25 (Solution D).

Cat. #01700 1 L of Solution D at 146.93 µS/cm Includes Reference Blank.Cat. #01800 500 mL of Solution D at 146.93 µS/cm

Includes Reference Blank.Cat. #01900 125 mL of Solution D at 146.93 µS/cm

Includes Reference Blank.Cat. #02000 125 mL Wide Mouth Pre-cleaned HDPE containers for measuring calibration solutions.Cat. #01500 1 L Solution D test Kit

Includes Solution D, Reference Blank,and 20 pre-cleaned 125 mL containers.

Cat. #01600 500 mL Solution D test Kit Includes Solution D, Reference Blank, and 10 pre-cleaned 125 mL containers.

24


PRA Sample Vials and Containers

Ever wonder what the USP means by: “Use glassware and sample containers that have been

scrupulously cleaned of organic residues?”1

Just like the USP, we here at PRA demand scrupulously cleaned vials for our TOC standards. All of our

vials, whether glass or polymer, represent the most consistently clean sample vials available anywhere.

They are the perfect vial for your purifi ed water (PW) or water for injection (WFI) sample analysis.

40 mL Glass TOC vials40 mL Low TOC vials (80/cs)Cat. #25025 We have partnered with C&G containers to develop

a process that removes virtually all residual TOC

from our 40 mL sample vials; our average residual

TOC level is < 5 ppb. How do we know this?

Because we analyze every single batch.

Over the years our data demonstrates that these

vials are uniformly lower in TOC than any other vial

available. Each case of vials (80 per case) is packaged

in a clean-room quality carton and comes with a

certifi cate of analysis to document their quality. Each

vial is capped with a Tefl on-lined septa and protected

by a hardened plastic dust cover. We guarantee these

low-level TOC vials will exceed your expectations.

Plastic Containers

AnatelCat. #25030 60 mL HDPE Bottle for Anatel A 643 (natural)Cat. #25033 60 mL HDPE Bottle for Anatel A 643 (amber)

SieversCat. #25015 30 mL poly vial for Sievers® Model 400Cat. #02000 125 mL Wide Mouth HDPE container

Pre-cleaned HDPE containers formeasuring calibration solutions.

1 United States Pharmacopeia Monographs, Chapter <661>–Containers.

25


Your Product When You Need It

Think of PRA as your stockroom for TOC

and Cleaning Validation products. Let us

know what you need and when you need

it, and we’ll take care of the rest.

We deliver product around the world,

shipping hundreds of packages per

week between our Arvada, Colorado,

US and Manchester, UK manufacturing

facilities. We understand the importance

of delivering our products promptly

and reliably and that’s why we work

with two preferred couriers FedEx™

and UPS™. Customers can select to use

their own account or we can ship using

international rates. Package tracking is

available and in the event of delivery

exceptions, customers are notifi ed and

we expedite delivery from our end.

Same day shipping is available on most

products. For orders received before

13:00 GMT Monday through Thursday,

you’ll receive them the next working day.

26


Custom PRA Products

TOC and Conductivity StandardsPRA maintains the most complete list of TOC standards available anywhere; however, it is possible

that you have a need for a standard we do not list in our catalog. If that is the case, please call us!

PRA’s chemists have many years of experience in preparing TOC standards. If the standard you

need can be made, we would be pleased to manufacture it for you. We begin by listening to your

requirements and then asking some questions of our own to make certain we know exactly what

you need. For example, the TOC standards we prepare for on-line analyzers are unpreserved and

handled differently than standards prepared for use with laboratory analyzers. Furthermore, we

need to make certain we use the appropriate source material and manufacture to the correct level of

uncertainty (error). Once we know exactly what TOC standard you would like, we prepare, test and

certify the standard for you. We will ship you the standard together with a complete Certifi cate of

Analysis. Our turn around time is typically 24-48 hours, and we do not have any premium charges

for preparing the product specifi cally for you. You can count on the fact that if a TOC or conductivity

standard can be made, PRA has the technical capability and experience to make it for you.

Cleaning Validation CouponsPRA continues to maintain a leadership role in cleaning validation products.

Coupons of any composition (metals, rubbers, plastics) are available with custom cutting, cleaning,

serialization and scoring. Coupons come with Certifi cates of Analysis for cleanliness and materials

traceability (exact material specifi cations like type, density and fi nish).

Coupon spiking services for product recovery studies, swabbing validation, “visually clean”

training and analyst performance qualifi cations are available.

Cleaning Validation Coup

27


TOC Standards by Manufacturer

AnatelPlease see pages 6-8 for Anatel product descriptions.

60 mL Single-Use A-643 Standards (unpreserved)Cat. #02610 100 µS/cm Conductivity Soln Kit Cat. #13300 Calibration Blank Cat #13390 USP SST with 250 ppb check Cat. #13400 0.250 ppm NIST Sucrose Cat. #13500 0.500 ppm NIST Sucrose Cat. #13600 0.750 ppm NIST Sucrose Cat. #18400 USP System Suitability Set Cat. #19200 Access 643 Calibration

Standards KitCat. #19210 Access 643 Validation Kit Cat. #19220 Access 643 Validation

Control KitCat. #19230 Access 643 Validation Protocol

Standards Kit

Cat. #25045 Low TOC Sample Vial Kit

Bulk Packaged Standards for Access 643 (unpreserved)Cat. #10019 Calibration Blank – 125 mL Cat. #10319 0.250 ppm NIST Sucrose – 125 mL Cat. #10619 0.500 ppm NIST Sucrose – 125 mL Cat. #10919 0.750 ppm NIST Sucrose – 125 mL Cat. #02600 100 µS/cm Conductivity Cal Standard – 125 mLCat. #18035 System Suitability Set – 125 mL Cat. #10031 Calibration Blank – 250 mL Cat. #10331 0.250 ppm NIST Sucrose – 250 mL Cat. #10631 0.500 ppm NIST Sucrose – 250 mL Cat. #10931 0.750 ppm NIST Sucrose – 250 mL Cat. #02250 100 µS/cm Conductivity Soln

Standard – 250 mLCat. #18060 System Suitability Set – 250 mL Cat. #10120 Calibration Blank – 500 mL Cat. #10420 0.250 ppm NIST Sucrose – 500 mL Cat. #10720 0.500 ppm NIST Sucrose – 500 mL Cat. #11020 0.750 ppm NIST Sucrose – 500 mL Cat. #02500 100 µS/cm Conductivity Cal

Standard – 500 mLCat. #18150 System Suitability Set – 500 mL

Single-Use Anatel AnaTOC Standards (preserved)Cat. #10015 TOC Water Blank – 125 mL Cat. #11720 0.250 ppm NIST KHP – 125 mL Cat. #11730 0.500 ppm NIST KHP – 125 mL Cat. #11810 1.00 ppm NIST KHP – 125 mL Cat. #18025 USP System Suitability Set – 125 mL Cat. #10025 TOC Water Blank – 250 mL Cat. #11721 0.250 ppm NIST KHP – 250 mL Cat. #11735 0.500 ppm NIST KHP – 250 mL Cat. #11820 1.00 ppm NIST KHP – 250 mL Cat. #18050 USP System Suitability Set – 250 mL Cat. #10100 TOC Water Blank – 500 mL Cat. #11722 0.250 ppm NIST KHP – 500 mL Cat. #11750 0.500 ppm NIST KHP – 500 mL Cat. #11900 1.00 ppm NIST KHP – 500 mL Cat. #13299 1000 ppm NIST KHP – 500 mL Cat. #18100 USP System Suitability Set – 500 mL Cat. #25025 40 mL Low TOC vials (80/cs)

Single-use Standards for the Anatel A-1000Cat. #10211 Calibration Blank – 1 L Cat. #10511 0.250 ppm NIST Sucrose – 1 L Cat. #10811 0.500 ppm NIST Sucrose – 1 L Cat. #11111 0.750 ppm NIST Sucrose – 1 L Cat. #19030 USP System Suitability Set – 1 L

All of PRA’s unpreserved standards have a 30-day expiration period regardless of size. Preserved

single-use standards have a 60-day expiration period and bulk preserved standards have a 6-month

expiration period.

The following is not a complete list of all volumes and concentrations of TOC standards offered by

PRA; please call us if there is a product you need that you cannot locate here.

28



Sievers® 400, 400 ES and Thornton 5000Please see page 11 for product descriptions.

30 mL Unpreserved Standards Cat. #13700 Calibration Blank Cat. #14100 1.25 ppm NIST Sucrose for

calibrationCat. #02700 25 µS/cm Conductivity for

calibrationCat. #18300 Model 400 USP System

Suitability Set

Bulk Packaged Standards – 6-month expiration

System Suitability SetsCat. #18030 System Suitability Set – 125 mL Cat. #18055 System Suitability Set – 250 mL Cat. #18140 System Suitability Set – 500 mL Cat. #18240 System Suitability Set – 1 L

125 mL TOC Calibration StandardsCat. #10020 Calibration Blank Cat. #11520 1.25 ppm NIST Sucrose

Calibration StandardCat. #01400 25 µS/cm Conductivity

Calibration Standard







VialsCat. #25015 30 mL poly vial for Sievers® Model 400

Did you know?Watch for Process Analytical Technology (PAT)

developments through the FDA’s Center for

Drug Evaluation and Research (CDER). The

Offi ce of Pharmaceutical Science (OPS) has

formed a new subcommittee of the Advisory

Committee for Pharmaceutical Science: the

Process Analytical Technologies Subcommittee,

to assemble expert advice on process analytical

technologies. You can keep up to date by

visiting http://cdernet.cder.fda.gov/ops/pat.

29


Shimadzu, Sievers® 800 and 900, AJ N/C 2100/3100, Lachat IL 550Please see pages 5, 10-13 for product descriptions.

Cat. #10000 TOC Water Blank Cat. #11701 0.050 ppm NIST KHP Cat. #11704 0.060 ppm NIST KHP Cat. #11707 0.070 ppm NIST KHP Cat. #11710 0.080 ppm NIST KHP Cat. #11713 0.090 ppm NIST KHP Cat. #11716 0.100 ppm NIST KHP Cat. #11719 0.250 ppm NIST KHP Cat. #11725 0.500 ppm NIST KHP Cat. #11780 0.750 ppm NIST KHP Cat. #11800 1.00 ppm NIST KHP Cat. #12100 2.00 ppm NIST KHP Cat. #12350 4.00 ppm NIST KHP Cat. #12400 5.00 ppm NIST KHP Cat. #12700 10.0 ppm NIST KHP Cat. #12905 12.0 ppm NIST KHP Cat. #12910 12.5 ppm NIST KHP Cat. #12940 15.0 ppm NIST KHP Cat. #13000 25.0 ppm NIST KHP Cat. #13210 30.0 ppm NIST KHP Cat. #13225 50.0 ppm NIST KHP Cat. #13275 100 ppm NIST KHP Cat. #13280 150 ppm NIST KHP Cat. #13285 200 ppm NIST KHP Cat. #13290 250 ppm NIST KHP Cat. #13295 500 ppm NIST KHP

System Suitability SetsBulk system suitability sets include one each:

Reagent Water RW, USP Sucrose RS (0.500 ppm), and

USP 1,4-benzoquinone RSS (0.500 ppm)

Cat. #18000 USP System Suitability Set – 40 mL

Validation Sets (40 mL vials)Cat. #19500 Sievers® 800 Autosampler

Calibration SetCat. #19510 Sievers® 800 Grab Mode

Calibration SetCat. #19515 Sievers® 800 Linearity Set Cat. #19520 Sievers® 800 Low-Level

Validation Set

125 mL Bulk StandardsCat. #10015 TOC Water Blank Cat. #11702 0.050 ppm NIST KHP Cat. #11717 0.100 ppm NIST KHP Cat. #11720 0.250 ppm NIST KHP Cat. #11730 0.500 ppm NIST KHP Cat. #11785 0.750 ppm NIST KHP Cat. #11810 1.00 ppm NIST KHP Cat. #12110 2.00 ppm NIST KHP Cat. #12360 4.00 ppm NIST KHP Cat. #12410 5.00 ppm NIST KHP Cat. #12710 10.0 ppm NIST KHP Cat. #12912 12.5 ppm NIST KHP Cat. #12945 15.0 ppm NIST KHP Cat. #13020 25.0 ppm NIST KHP Cat. #13226 50.0 ppm NIST KHP

250 mL Bulk StandardsCat. #10025 TOC Water Blank Cat. #11703 0.050 ppm NIST KHP Cat. #11718 0.100 ppm NIST KHP Cat. #11721 0.250 ppm NIST KHP Cat. #11735 0.500 ppm NIST KHP Cat. #11790 0.750 ppm NIST KHP Cat. #11820 1.00 ppm NIST KHP Cat. #12120 2.00 ppm NIST KHP Cat. #12420 5.00 ppm NIST KHP Cat. #12720 10.0 ppm NIST KHP Cat. #12914 12.5 ppm NIST KHP Cat. #12950 15.0 ppm NIST KHP Cat. #13040 25.0 ppm NIST KHP Cat. #13228 50.0 ppm NIST KHP Cat. #13277 100 ppm NIST KHP

500 mL Bulk StandardsCat. #10100 TOC Water Blank Cat. #11714 0.100 ppm NIST KHP Cat. #11722 0.250 ppm NIST KHP Cat. #11750 0.500 ppm NIST KHP Cat. #11795 0.750 ppm NIST KHP Cat. #11900 1.00 ppm NIST KHP Cat. #12200 2.00 ppm NIST KHP Cat. #12500 5.00 ppm NIST KHP Cat. #12800 10.0 ppm NIST KHP Cat. #12920 12.5 ppm NIST KHP Cat. #12955 15.0 ppm NIST KHP Cat. #13100 25.0 ppm NIST KHP Cat. #13215 30.0 ppm NIST KHP Cat. #13230 50.0 ppm NIST KHP Cat. #13278 100 ppm NIST KHP


30



OI Analytical, Teledyne Tekmar, AJ N/C UV HS, Lachat IL 500Please see pages 5, 9, 14-15 for product descriptions.

40 mL Single Use Vials and Sets Cat. #10001 TOC Water Blank Cat. #11666 0.050 ppm NIST KHP Cat. #11669 0.060 ppm NIST KHP Cat. #11670 0.070 ppm NIST KHP Cat. #11671 0.080 ppm NIST KHP Cat. #11672 0.090 ppm NIST KHP Cat. #11673 0.100 ppm NIST KHP Cat. #11678 0.250 ppm NIST KHP Cat. #11726 0.500 ppm NIST KHP Cat. #11781 0.750 ppm NIST KHP Cat. #11801 1.00 ppm NIST KHP Cat. #12101 2.00 ppm NIST KHP Cat. #12401 5.00 ppm NIST KHP Cat. #12701 10.0 ppm NIST KHP Cat. #13001 25.0 ppm NIST KHP Cat. #13224 50.0 ppm NIST KHP Cat. #18006 RW-Reagent Water USP Cat. #18007 RS-0.500 ppm from USP

Sucrose RSCat. #18008 RSS-0.500 ppm from USP

BenzoquinoneCat. #13273 100 ppm NIST KHP

Validation SetsCat. #19007 OI Analytical Validation Set –Aurora Cat. #19002 Teledyne Tekmar Validation Set–

PhoenixCat. #19004 Teledyne Tekmar Validation Set–

FusionCat. #14203 OI and Tekmar Low-Level

Linearity Set

System Suitability SetsSystem suitability sets include one each: Reagent

Water RW, USP Sucrose RS (0.500 ppm), and USP

1,4-benzoquinone RSS (0.500 ppm)

Cat. #18004 USP System Suitability Set – 40 mL Cat. #18024 System Suitability Set – 125 mL Cat. #18049 System Suitability Set – 250 mL Cat. #18104 System Suitability Set – 500 mL Cat. #18204 System Suitability Set – 1 L

125 mL Bulk StandardsCat. #10016 TOC/IC Calibration Blank Cat. #11667 0.050 ppm from NIST KHP Cat. #11674 0.100 ppm from NIST KHP Cat. #11731 0.500 ppm from NIST KHP Cat. #10786 0.750 ppm from NIST KHP Cat. #11811 1.00 ppm from NIST KHP Cat. #12411 5.00 ppm from NIST KHP Cat. #12711 10.0 ppm from NIST KHP Cat. #13021 25.0 ppm from NIST KHP Cat. #13227 50.0 ppm from NIST KHP Cat. #13305 1000 ppm from NIST KHP Cat. #13308 2000 ppm from NIST KHP Cat. #18029 RW-Reagent Water USP Cat. #18031 RS-0.500 ppm from USP


Benzoquinone

250 mL Bulk StandardsCat. #10026 TOC/IC Calibration Blank Cat. #11668 0.050 ppm from NIST KHP Cat. #11675 0.100 ppm from NIST KHP Cat. #10322 0.250 ppm from NIST Sucrose Cat. #11736 0.500 ppm from NIST KHP Cat. #10622 0.500 ppm from NIST Sucrose Cat. #11791 0.750 ppm from NIST KHP Cat. #10922 0.750 ppm from NIST Sucrose Cat. #11821 1.00 ppm from NIST KHP Cat. #12121 2.00 ppm from NIST KHP Cat. #12421 5.00 ppm from NIST KHP Cat. #12721 10.0 ppm from NIST KHP Cat. #13041 25.0 ppm from NIST KHP Cat. #13229 50.0 ppm from NIST KHP Cat. #13306 1000 ppm from NIST KHP Cat. #13309 2000 ppm from NIST KHP Cat. #18046 RW-Reagent Water USP Cat. #18047 RS-0.500 ppm from USP Sucrose RS Cat. #18048 RSS-0.500 ppm from USP

Benzoquinone

31


500 mL Bulk StandardsCat. #10101 TOC/IC Calibration Blank Cat. #11676 0.100 ppm from NIST KHP Cat. #10401 0.250 ppm from NIST Sucrose Cat. #11751 0.500 ppm from NIST KHP Cat. #10701 0.500 ppm from NIST Sucrose Cat. #11796 0.750 ppm from NIST KHP Cat. #11001 0.750 ppm from NIST Sucrose Cat. #11901 1.00 ppm from NIST KHP Cat. #12201 2.00 ppm from NIST KHP Cat. #12501 5.00 ppm from NIST KHP Cat. #12801 10.0 ppm from NIST KHP Cat. #13101 25.0 ppm from NIST KHP Cat. #13231 50.0 ppm from NIST KHP Cat. #13307 1000 ppm from NIST KHP Cat. #13310 2000 ppm from NIST KHP Cat. #18105 RW-Reagent Water USP Cat. #18106 RS-0.500 ppm from USP


Benzoquinone

1000 mL Bulk StandardsCat. #10201 TOC/IC Calibration Blank Cat. #11677 0.100 ppm from NIST KHP Cat. #10501 0.250 ppm from NIST Sucrose Cat. #11776 0.500 ppm from NIST KHP Cat. #10801 0.500 ppm from NIST Sucrose Cat. #11101 0.750 ppm from NIST Sucrose Cat. #12001 1.00 ppm from NIST KHP Cat. #12301 2.00 ppm from NIST KHP Cat. #12601 5.00 ppm from NIST KHP Cat. #12901 10.0 ppm from NIST KHP Cat. #13201 25.0 ppm from NIST KHP Cat. #13236 50.0 ppm from NIST KHP Cat. #18205 RW-Reagent Water USP Cat. #18206 RS-0.500 ppm from USP

Sucrose RS Cat. #18207 RSS-0.500 ppm from US

Benzoquinone

TOC VialsCat. #25025 40 mL Low TOC vials (80/cs)


Floats Road Wythenshawe Manchester M23 9LZ U.K.

pharmaceutical reference standards - pmt france€¦ · 7 anatel access 643 & a643a bulk...

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