le117, leucovorin calcium, usp · 2020. 9. 4. · specification for leucovorin calcium, usp (le117)...

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Not appropriate for regulatory submission. Please visit www.spectrumchemical.com or contact Tech Services for the most uptodate information contained in this information package. Spectrum Chemical Mfg Corp 769 Jersey Avenue New Brunswick, NJ 08901 Phone 732.214.1300 Ver4.04 05.August.2019 Scientific Documentation LE117, Leucovorin Calcium, USP

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Page 1: LE117, Leucovorin Calcium, USP · 2020. 9. 4. · Specification for Leucovorin Calcium, USP (LE117) Item Number LE117 Item Leucovorin Calcium, USP CAS Number 1492-18-8 Molecular Formula

                        

            

  

Not appropriate for regulatory submission. Please visit www.spectrumchemical.com or contact Tech Services for the most up‐to‐date information contained in this information package.    

Spectrum Chemical Mfg Corp 769 Jersey Avenue New Brunswick, NJ 08901 Phone  732.214.1300   

Ver4.04  05.August.2019 

    Scientific Documentation LE117, Leucovorin Calcium, USP

Page 2: LE117, Leucovorin Calcium, USP · 2020. 9. 4. · Specification for Leucovorin Calcium, USP (LE117) Item Number LE117 Item Leucovorin Calcium, USP CAS Number 1492-18-8 Molecular Formula

Dear Customer,

Thank you for your interest in Spectrum’s quality products and services.

Spectrum has been proudly serving the scientific community for over 45 years. It is our mission to manufacture and distribute fine chemicals and laboratory products with Quality and delivery you can count on every time.

To accomplish our mission, Spectrum utilizes our sourcing leverage and supplier qualification expertise in offering one of the industry’s most comprehensive line of fine chemical products under one brand, in packaging configurations designed to meet your research and production requirements. Our product grades include: USP, NF, BP, EP, JP, FCC, ACS, KSA, Reagent grade, as well as DEA controlled substances. We operate facilities in the United States on the East Coast, West Coast, as well as in Shanghai, China in order to provide the best logistical support for our customers.

At Spectrum, Quality is priority number one. Suppliers with the best qualifications are preferred and we employ full-functioning in-house analytical laboratories at each of our facilities. Our facilities and systems are USFDA registered and ISO certified. We frequently host customer audits and cherish opportunities for improvements. Quality is engrained into our culture. Quality is priority number one.

In the following pages, we have designed and prepared documented scientific information to aid you in your initial qualification or your continual use of our products. Please do not hesitate to contact us if further information or the most up-to-date documentation is desired from any of the covered areas.

We appreciate your business and we look forward to hearing from you.

Sincerely,

Michael Dang Director, Quality Systems & GMP Compliance [email protected]

05.August.2019

Page 3: LE117, Leucovorin Calcium, USP · 2020. 9. 4. · Specification for Leucovorin Calcium, USP (LE117) Item Number LE117 Item Leucovorin Calcium, USP CAS Number 1492-18-8 Molecular Formula

LE117, Leucovorin Calcium, USP

Table of Contents

Product Specification

Safety Data Sheet (SDS)

Certification of Quality Management System (QMS)

Certification of current Good Manufacturing Practices (cGMP)

Product BSE/TSE Statement

Product Allergen Statement

Product Aflatoxin Statement

Product Certificate of Analysis Sample(s)

General Label Information – Sample Label

General Lot Numbering System Guidance

Stability – Shelf Life Guidance

Halal Certificate

Page 4: LE117, Leucovorin Calcium, USP · 2020. 9. 4. · Specification for Leucovorin Calcium, USP (LE117) Item Number LE117 Item Leucovorin Calcium, USP CAS Number 1492-18-8 Molecular Formula

Specification for Leucovorin Calcium, USP (LE117)

Item Number LE117

Item Leucovorin Calcium, USP

CAS Number 1492-18-8

Molecular Formula C20H21CaN7O7

Molecular Weight 511.50

MDL Number

Synonyms Folinic Acid Calcium Salt

Test SpecificationMin Max

ASSAY (ANHYDROUS BASIS) 95.0 105.0 %

WATER DETERMINATION 17.0 %

ELEMENTAL IMPURITIES AS REPORTED

IDENTIFICATION TO PASS TEST

CERTIFIED HALAL

RETEST DATE

DATE OF MANUFACTURE

APPEARANCE

RESIDUAL SOLVENTS TO PASS TEST

Page 5: LE117, Leucovorin Calcium, USP · 2020. 9. 4. · Specification for Leucovorin Calcium, USP (LE117) Item Number LE117 Item Leucovorin Calcium, USP CAS Number 1492-18-8 Molecular Formula

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Page 6: LE117, Leucovorin Calcium, USP · 2020. 9. 4. · Specification for Leucovorin Calcium, USP (LE117) Item Number LE117 Item Leucovorin Calcium, USP CAS Number 1492-18-8 Molecular Formula

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Page 7: LE117, Leucovorin Calcium, USP · 2020. 9. 4. · Specification for Leucovorin Calcium, USP (LE117) Item Number LE117 Item Leucovorin Calcium, USP CAS Number 1492-18-8 Molecular Formula

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Page 8: LE117, Leucovorin Calcium, USP · 2020. 9. 4. · Specification for Leucovorin Calcium, USP (LE117) Item Number LE117 Item Leucovorin Calcium, USP CAS Number 1492-18-8 Molecular Formula

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Page 9: LE117, Leucovorin Calcium, USP · 2020. 9. 4. · Specification for Leucovorin Calcium, USP (LE117) Item Number LE117 Item Leucovorin Calcium, USP CAS Number 1492-18-8 Molecular Formula

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Page 20: LE117, Leucovorin Calcium, USP · 2020. 9. 4. · Specification for Leucovorin Calcium, USP (LE117) Item Number LE117 Item Leucovorin Calcium, USP CAS Number 1492-18-8 Molecular Formula

C O R P O R A T E H E A D Q U A R T E R S

769 Jersey Avenue

New Brunswick, NJ 08901

PHONE 732.214.1300

FAX 732.246.7132

A N I S O 90 0 1 :2 0 15 RE G IS T E RE D COM P A NY

W E S T C O A S T F A C I L I T Y

14422 South San Pedro Street

Gardena, California 90248

PHONE 310.516.8000

FAX 310.516.9843

w w w . s p e c t r u m c h e m i c a l . c o m

January 08, 2019 Certification of Compliance with current Good Manufacturing Practices Dear Valued Customer: Spectrum Chemical Mfg Corp certifies that our USP, NF, FCC, EP, BP, JP, and food grade products are produced, processed, packaged and held in compliance with current Good Manufacturing Practices (cGMP) in accordance with the applicable parts of 21 CFR, parts 210 and 211 and parts 110 and 111 of the Code of Federal Regulations, respectively. Spectrum is an FDA registered and inspected Drug Establishment. Our United States Food and Drug Administration (USFDA) Registration numbers are as follows: Spectrum Gardena, California: 2020632 Spectrum New Brunswick, New Jersey: 2246824 Thank you for your interest in Spectrum products. Please feel free to contact me at 310-516-8000, extension 5610 or via email at [email protected] if I may be of further assistance. Sincerely,

Michael Dang Director, Quality Systems & GMP Compliance

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August 05, 2019

Certification of Compliance with current Good Manufacturing Practices

Dear Valued Customer:

Spectrum Chemical Mfg Corp certifies that the following product(s) is produced, processed, packaged and held in compliance with current Good Manufacturing Practices (cGMP) in accordance with the applicable parts of 21 CFR, parts 210 and 211 of the Code of Federal Regulations.

Catalog Number Product Name LE117 Leucovorin Calcium, USP

Spectrum is an FDA registered and inspected Drug Establishment. Our United States Food and Drug Administration (USFDA) Registration numbers are as follows:

Spectrum-Gardena, CA: 2020632 Spectrum-New Brunswick, NJ: 2246824 Spectrum-Shanghai, China: 03006174778

Thank you for your interest in Spectrum products. If we may be of further assistance, please feel free to contact the Quality Assurance department at 310-516-8000 or via email at [email protected]

Sincerely,

Oralia Chavez Quality Assurance Specialist

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May 4, 2016 Re: Leucovorin Calcium, USP- LE117 To Whom It May Concern: Thank you for your interest in Spectrum high quality chemicals. We at Spectrum Chemical Mfr. Corp. understand the concern regarding Bovine Spongiform Encephalopathy (BSE). Please be assured that the chemical Leucovorin Calcium, USP- LE117 is BSE/TSE free. If you have any further questions, please contact Tech Services at (310) 516- 8000 Extension 5471, or by email at [email protected]. Sincerely, Darlene Dagdag-Lyudmirskiy Technical Services Spectrum Chemical Mfr. Corp. This document has been produced electronically and is valid without a signature

Page 23: LE117, Leucovorin Calcium, USP · 2020. 9. 4. · Specification for Leucovorin Calcium, USP (LE117) Item Number LE117 Item Leucovorin Calcium, USP CAS Number 1492-18-8 Molecular Formula

May 3, 2016 Re: Leucovorin Calcium, USP- LE117 To Whom It May Concern: Thank you for your interest in Spectrum high quality chemicals. We at Spectrum Chemical Mfr. Corp. understand the concern regarding the presence of allergens in raw materials. Please be assured that the following chemical does not contain (Milk; Egg; Fish; Shellfish; Sulfur dioxide and sulfites at concentrations of more than 10 mg/kg or 10 mg/liter expressed as SO2; Lupin; Tree nuts; Mollusks; Wheat; Peanuts; Soy; Cereals containing Gluten; Celery; Mustard; Sesame Seed). Leucovorin Calcium, USP- LE117

If you have any further questions, please contact Tech Services at (310) 516- 8000 Extension 5471, or by email at [email protected]. Sincerely, Darlene Dagdag-Lyudmirskiy Technical Services Spectrum Chemical Mfr. Corp. This document has been produced electronically and is valid without a signature

Page 24: LE117, Leucovorin Calcium, USP · 2020. 9. 4. · Specification for Leucovorin Calcium, USP (LE117) Item Number LE117 Item Leucovorin Calcium, USP CAS Number 1492-18-8 Molecular Formula

May 3, 2016 Re: Leucovorin Calcium, USP- LE117 To Whom It May Concern: Thank you for your interest in Spectrum high quality chemicals. We at Spectrum Chemical Mfg. Corp. understand the concern regarding Aflatoxins in raw materials. To the best of our knowledge, the product listed below is not contaminated with Aflatoxins. Aflatoxins are not used in production. The following product does not come in contact with Aflatoxins at any stage of production. Leucovorin Calcium, USP- LE117 If you have any further questions, please contact Tech Services at (310) 516- 8000 Extension 5471, or by email at [email protected]. Sincerely, Darlene Dagdag-Lyudmirskiy Technical Services Spectrum Chemical Mfr. Corp. This document has been produced electronically and is valid without a signature

Page 25: LE117, Leucovorin Calcium, USP · 2020. 9. 4. · Specification for Leucovorin Calcium, USP (LE117) Item Number LE117 Item Leucovorin Calcium, USP CAS Number 1492-18-8 Molecular Formula

Certificate Of Analysis

Item Number LE117 Lot Number 1IE1377

Item Leucovorin Calcium, USP Manufacturer Lot 20190204

CAS Number 1492-18-8 Manufacturer Code 9949

Molecular Formula C20H21CaN7O7 Molecular Weight 511.50

Test Specification Resultmin max

95.0 105.0 % 98.7 %

17.0 % 9.65 %

AS REPORTED COMPLIES WITHSTANDARD

TO PASS TEST PASSES TEST

CERTIFIED HALAL

17-FEB-2021

18-FEB-2019

YELLOWISHWHITE POWDER

TO PASS TEST PASSES TEST

<5000 ppm

<5000 ppm

Spectrum Chemical Mfg Corp

14422 South San Pedro Street

Gardena 90248 CA

All pharmaceutical ingredients are tested using current edition of applicable pharmacopeia.

Read and understand label and SDS before handling any chemicals. All Spectrum's chemicals are for manufacturing, processing,repacking or research purposes by experienced personnel only. It is the customer's responsibility to provide adequate hazardousmaterial training and ensure that appropriate Personal Protective Equipment (PPE) is used before handling any chemical.

The Elemental Impurities standards implemented by USP and other Pharmaceutical Compendia reflect a growing understandingof the toxicology of trace levels of elemental impurities that can remain in drug substances originating from either raw materials ormanufacturing processes. Identifying and quantifying impurities can be critical to predicting the best possible patient outcomes.Elemental Impurities has been a requirement of all products meeting USP/NF, EP and BP monographs since January 1, 2018.More information can be found in USP sections <232> Elemental Impurities – Limits and <233> Elemental Impurities –Procedures. Data for drug substances furnished by Spectrum Chemical Mfg. Corp can be used to ensure that patient dailyexposures by oral administration to the selected elements are not exceeded in the formulation of pharmaceutical products.

Spectrum Chemical Mfg. Corp. repackages Active Pharmaceutical Ingredient chemicals provided by other manufacturers andsuppliers. For traceability purposes, Spectrum's Certificate of Analysis contains an identifier code unique to each manufacturer orsupplier, as well as the chemical's lot number provided on the original manufacturer Certificate of Analysis. Test results for theoriginal Certificate of Analysis are available upon request from your Spectrum Sales Representative or by calling Spectrum'sQuality Department at 1-800-772-8786.

Page 26: LE117, Leucovorin Calcium, USP · 2020. 9. 4. · Specification for Leucovorin Calcium, USP (LE117) Item Number LE117 Item Leucovorin Calcium, USP CAS Number 1492-18-8 Molecular Formula

*49452le117062233ATA*

www.SpectrumChemical.com

Rete

st D

ate:

03-

31-2

025

Chemical Emergency: (800)424-9300

LE117 500 GLeucovorin

Calcium(Folinic Acid Calcium Salt)

U.S.P.CAS 1492-18-8

CAUTION: For manufacturing, processing, repacking, or for prescription compounding. Rx only. Read and understand the label and Safety Data Sheet (SDS) prior to use.

WARNING• Causes serious eye irritation • Causes skin irritation • May cause respiratory irritation.• Wear protective gloves, eye protection, face protection • Avoid breathing dust • Use only outdoors or in a well-ventilated area • Wash face, hands and any exposed skin thoroughly after handling.FIRST AID: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical attention. IF ON SKIN: Wash with plenty of water. Take off contaminated clothing and wash it before reuse. If skin irritation occurs: Get medical attention. IF INHALED: Remove person to fresh air and keep comfortable for breathing. Call a POISON CENTER or physician if you feel unwell.

KEEP FROM CHILDREN

G 10/E4GHS A Lot No. 062233

C20H21CaN7O7 F.W. 511.50

Assay (Anhydrous Basis) ................ 95.0-105.0%MAXIMUM LIMITS

Water ........................................................ 17.0%Heavy Metals (as Pb) .............................. 0.005%Residual Solvents .............................To pass test

WARNING: This product contains a chemical known to the State of California to cause cancer.

WARNING: This product contains a chemical known to the State of California to cause birth defects or other reproductive harm.

LIGHT SENSITIVE: Keep tightly closed in light-resistant containers.

Xx

SPECTRUM CHEMICAL MFG. CORP. Gardena, CA 90248 • New Brunswick, NJ 08901

Empirical Formula, Formula Weight and Technical Specifications Panel

Expiration Information

Lot Number

Kosher Certified by Kosher Supervision of America (KSA).

Bar CodeGHS Hazard PictogramsWarning, Safety Data and Precautionary InformationProduct Catalog NumberItem Name, Form, Grade

Size/Quantity

Chemical Abstracts Service (CAS) Registry Number

Caution Information

DOT Shipping Information

Toll-Free 24-Hour Chemical Emergency Telephone Number

B

K

D

A

I

C

H

F

G

L

E

J

YELLOW: Oxidizer

RED: Flammable

GREEN: General Storage

BLUE: Health Hazard

WHITE: Corrosive

Storage Color Band

This color-coded band indicates the hazard most likely to be posed by that material under storage conditions. The criteria used to assign band colors have been established by the Storage Code working group of the Society for Chemical Hazard Communication (SCHC). It is recommended that like colors be stored together, unless otherwise stated, based on the color codes indicated to the right. However, it is the responsibility of the customer to check with their local fire department for possible conflicts with our recommendations when storing hazardous chemicals.

O

Label Legend

M

N

The Spectrum label presents technical and safety information in an easily understood format. Our technical specialists stay abreast of the latest requirements of the Globally Harmonized System for Classification and Labelling of Chemicals (GHS), as well as the Occupational Safety and Health Administration (OSHA), the Food and Drug Administration (FDA) and other government regulatory agencies in order to ensure compliance, accuracy and concise hazard communication.

G

D

J

H

E

F

KA

M

OL

Spectrum Chemical Mfg Corp

Corporate Headquarters: West Coast Facility:

769 Jersey Ave. 14422 S. San Pedro St.

New Brunswick, NJ 08901 Gardena, CA 90248

732.214.1300 310.516.8000

Label Information

C B

Page 27: LE117, Leucovorin Calcium, USP · 2020. 9. 4. · Specification for Leucovorin Calcium, USP (LE117) Item Number LE117 Item Leucovorin Calcium, USP CAS Number 1492-18-8 Molecular Formula

C O R P O R A T E H E A D Q U A R T E R S

769 Jersey Avenue

New Brunswick, NJ 08901

PHONE 732.214.1300

FAX 732.246.7132

A N I S O 90 0 1 :2 0 15 RE G IS T E RE D COM P A NY

W E S T C O A S T F A C I L I T Y

14422 South San Pedro Street

Gardena, California 90248

PHONE 310.516.8000

FAX 310.516.9843

w w w . s p e c t r u m c h e m i c a l . c o m

February 1, 2019 RE: Lot Numbering System Dear Valued Customer: This letter is to inform you of Spectrum Chemicals and Laboratory Products’ Lot Numbering System. The system is based on an alpha-numerical sequence which provides the month, year and location of production. The lot numbering system utilized until 2010 is a sequence of six characters, two letters followed by four numbers. The first letter represents the year, for example, Y denotes 2009 and Z denotes 2010. The second letter represents the month and site, for example, A-L denotes January through December at Spectrum’s Gardena, CA facility, while M-X denotes January through December at the New Brunswick, NJ facility. The following four numbers are sequentially assigned.

Example: ZI0928 = The 928th material produced in California in September 2010 The lot numbering system utilized for 2011 and forward, is a sequence of seven characters. The first character, a number, represents the production facility: 1 = Gardena, CA Facility 2 = New Brunswick, NJ Facility 3 = China Facility 4 = Pharmacy, NJ Facility The second character, a letter, represents the year. For example, A denotes 2011 and B denotes 2012. The third character, a letter, represents the month, with A denoting January and L denoting December. The following four numbers are sequentially assigned.

Example: 2AA0706 = The 706th material produced in New Jersey in January 2011 Thank you for your interest with Spectrum products. Please feel free to contact us at 310-516-8000 or via email at [email protected] if we may be of further assistance.

Sincerely,

Howard Lau, Quality Assurance Specialist

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05.August.2019

Stability – Shelf Life Guidance Product Covered: LE117, Leucovorin Calcium, USP Spectrum Chemical’s manufacturing partner has assigned the following shelf life guidance for the product listed above. The product, LE117, Leucovorin Calcium, USP, is assigned a 24 months shelf life from date of manufacturing. The quality and integrity of the chemical depends on the handling and storage conditions. Please refer to the Safety Data Sheet for proper storage and handling procedures. Adan R. Hernandez Quality Control Manager

Corporate Headquarters 769 Jersey Avenue New Brunswick, NJ 08901-3605

Page 29: LE117, Leucovorin Calcium, USP · 2020. 9. 4. · Specification for Leucovorin Calcium, USP (LE117) Item Number LE117 Item Leucovorin Calcium, USP CAS Number 1492-18-8 Molecular Formula

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