List of Drugs and Excipients

37 Institute of Chemical Technology, Mumbai

© 2013, Vanita J. Sharma

List of Drugs

Drugs of Investigation Supplier Category

Metoprolol succinate USP

(M.succinate) Aurobindo Pharma Ltd, Mumbai Anti-hypertensive

Felodipine USP (FEL) Cipla Ltd Anti-hypertensive

Rifampicin USP (RIF) Lupin Laboratories Ltd, Pune Anti-tubercular,

anti-leprotic

Isoniazid BP (INH) Lupin Laboratories Ltd, Pune Anti-tubercular

List of Drugs and Excipients

38 Institute of Chemical Technology, Mumbai

© 2013, Vanita J. Sharma

Certificate of Analysis of Metoprolol succinate USP

List of Drugs and Excipients

39 Institute of Chemical Technology, Mumbai

© 2013, Vanita J. Sharma

Certificate of Analysis of Felodipine USP by Cipla

List of Drugs and Excipients

40 Institute of Chemical Technology, Mumbai

© 2013, Vanita J. Sharma

Certificate of Analysis of Rifampicin USP

List of Drugs and Excipients

41 Institute of Chemical Technology, Mumbai

© 2013, Vanita J. Sharma

Certificate of Analysis of Rifampicin USP (contd.)

List of Drugs and Excipients

42 Institute of Chemical Technology, Mumbai

© 2013, Vanita J. Sharma

Certificate of Analysis of Isoniazid BP

List of Drugs and Excipients

43 Institute of Chemical Technology, Mumbai

© 2013, Vanita J. Sharma

List of Excipients

Excipients Supplier Category

Acryl EZE®

Colorcon Asia Pvt Ltd,

Mumbai

Enteric release polymer

(pH > 5.5)

Aerosil® 200 Pharma Evonik Industries Glidant

Avicel®

PH101 Signet Chemicals Diluent

Eudragit®

EPO Evonik Industries Gastric release polymer

(pH 1-5)

Eudragit®

L100-55 (EL100-55) Evonik Industries Enteric release polymer

(pH > 5.5)

Eudragit®

RSPO Evonik Industries pH independent SR

polymer

Eudragit®

S100 Evonik Industries Enteric release polymer

(pH > 7)

Gelatin capsules Associated capsules Capsules

Glyceryl monostearate S. D Fine Chemicals,

Mumbai

Matrix former,

lubricant

HPMC capsules Capsugel SR capsules

Klucel®

(HF, MF and LF grades) Ashland, Mumbai pH independent SR

polymer (hydrophilic

Kollicoat® MAE100P BASF, Mumbai

Enteric release polymer

(pH > 5.5)

Kollidon®

SR (KSR) BASF, Mumbai SR polymer (plastic)

Kollidon® VA64 (KVA64) BASF, Mumbai Binder, Solubilizer

Lactose Signet Chemicals Diluent

Lutrol®

F68 BASF, Mumbai Surfactant

Magnesium stearate Bajaj Healthcare Ltd Lubricant

Methocel® (K100M, K4M, K15M

Premium and CR grades)

Colorcon Asia Pvt Ltd,

Mumbai

Non ionic, hydrophilic,

swellable polymer

Polyethylene glycol 400

(PEG 400) S. D Fine Chemicals Plasticizer

Polyethylene glycol 6000 S. D Fine Chemicals Binder, lubricant

List of Drugs and Excipients

44 Institute of Chemical Technology, Mumbai

© 2013, Vanita J. Sharma

Propylene glycol (PG) S. D Fine Chemicals Plasticizer

Stearic acid S. D Fine Chemicals Binder, lubricant

Stearic acid 1843 powder Lipidchem Sendirian

Berhad, Malaysia Binder, lubricant

Sterotex® HM, NF

Abitec Corporation,

Mumbai Binder, lubricant

Talc Bajaj Healthcare Ltd Glidant, lubricant

Triethyl citrate (TEC) S. D Fine Chemicals Plasticizer