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Atomic Absorption Spectrometry (AAS) For Copper Test

The document outlines quality control requirements for several pharmaceutical products including: 1) Glibenclamide and Metformin tablets which require testing of active ingredients and related compounds using HPLC columns. 2) Mefenamic acid tablets involving testing of the active ingredient and an impurity using atomic absorption spectrometry. 3) Metformin tablets requiring testing of the active ingredient and related impurities using HPLC columns. 4) Several other drug products and combinations requiring analysis of active ingredients and impurities using techniques like HPLC, potentiometry, melting point determination and TLC. Certificate of analysis are also required for APIs and inactive ingredients used in certain formulations.

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Wael Eishiger
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109 views3 pages

Atomic Absorption Spectrometry (AAS) For Copper Test

The document outlines quality control requirements for several pharmaceutical products including: 1) Glibenclamide and Metformin tablets which require testing of active ingredients and related compounds using HPLC columns. 2) Mefenamic acid tablets involving testing of the active ingredient and an impurity using atomic absorption spectrometry. 3) Metformin tablets requiring testing of the active ingredient and related impurities using HPLC columns. 4) Several other drug products and combinations requiring analysis of active ingredients and impurities using techniques like HPLC, potentiometry, melting point determination and TLC. Certificate of analysis are also required for APIs and inactive ingredients used in certain formulations.

Uploaded by

Wael Eishiger
Copyright
© Attribution Non-Commercial (BY-NC)
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as DOCX, PDF, TXT or read online on Scribd
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Date: 30/07/2011 Requirements of New Products ** Glibenclamide and Metformin Tablets USP Q.C.

Glibenclamide RS Glibenclamide Related Compound A RS Metformin HCL RS Metformin Related Compound B RS Metformin Related Compound C RS
0.45-m polypropylene filter 4.6-mm 15-cm column that contains 5-m packing L7 column 3.9-mm 30-cm column that contains 10-m packing L1 Column ** Mefenamic Acid Tablet BP Q.C.

Mefenamic acid RS 2, 3-Dimethylaniline (2, 3-Xylidine)


Atomic Absorption spectrometry (AAS) for Copper test ** Metformin HCL Tablet BP Q.C.

Metformin hydrochloride RS 1-Cyanoguanidine RS (Dicyandiamide) (Metformin impurity A) Melamine Column: size: l = 0.25 m, = 4.6 mm, stationary phase: irregular, porous silica gel to which benzenesulphonic acid groups have been chemically bonded (10 m),

or size: l = 0.11 m, = 4.7 mm, stationary phase: regular, porous silica gel to which benzenesulphonic acid groups have been chemically bonded (5 m).

Potentiometer ** Diphenhydramine HCL and Acetaminophen Tablets USP (Nilodol night) Q.C. Diphenhydramine HCL RS Diphenhydramine impurity A RS Diphenylmethanol R Column: size: l = 0.25 m, = 4.6 mm, stationary phase: base-deactivated octylsilyl silica gel for chromatography R (5 m).(RM) Potentiometer Metling point App. 4.6-mm 15-cm column that contains packing L10 Column (Final product) ** Acetaminophen, Chlorpheniramine maleate and Pseudoephedrine HcL Tablet USP (Cold&Flu) Chlorphenamine maleate RS Chlorphenamine impurity A RS Chlorphenamine impurity C RS Pseudoephedrine hydrochloride RS Ephedrine hydrochloride impurity RS Ninhydrin R

Columna stainless steel column 0.25 m long and 4.6 mm in internal diameter packed with phenylsilyl silica gel for chromatography R (5 m),

Triethylamine hydrochloride USP grade


4.6-mm 15-cm column that contains packing L11 Column Polarimeter Potentiometer (Non-aqueous) ** Prednil-5 tablet Prednisolone RS Hydrocortisone impurity RS TLC plate using kieselguhr G as the coating substance Tetrahydrofuran Dexamethasone Filter paper (Whatman GF/F)

Note: For DC granules of Metformin hydrochloride and Nilodol night tablet, We require all COA of API along with Ingredients and all COA of inactive ingredients used in the formulation.

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