Pharmacopoeia and Impurity Reference Standards

Pharmacopoeia and Impurity Reference Standards

Pharmacopoeia and impurity reference standards are authoritative materials used to verify drug identity, purity, potency, and impurity profiles in compliance with USP, EP, JP, ChP, and other global pharmacopeial requirements. These standards include active pharmaceutical ingredient (API) markers, degradation products, synthesis impurities, genotoxic impurities, and system suitability standards. They support method validation, stability studies, impurity qualification, and regulatory submission. Pharmacopoeial standards ensure consistent pharmaceutical quality and patient safety by enabling precise quantification of trace impurities and confirmation of drug specifications. Their certification involves rigorous analytical characterization, inter-laboratory validation, and continuous monitoring of stability.

Propafenone Ep Impurity D CAS NO 91401-73-9

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CAS No.:91401-73-9

Grade:Pharmacy Grade

Content:99.90%

Packaging:Customizable

Propafenone Impurity 23 (Propafenone Β-D-Glucuronide) CAS NO 91411-76-6

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CAS No.:91411-76-6

Grade:Pharmacy Grade

Content:99.90%

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4-Dimethylamino Antipyrine-D6 CAS NO 91419-95-3

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CAS No.:91419-95-3

Grade:Pharmacy Grade

Content:99.90%

Packaging:Customizable

Ketoconazole Impurity 20 CAS NO 91458-32-1

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CAS No.:91458-32-1

Grade:Pharmacy Grade

Content:99.90%

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Demethyl Naproxen Acyl-Β-D-Glucuronide CAS NO 91488-21-0

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CAS No.:91488-21-0

Grade:Pharmacy Grade

Content:99.90%

Packaging:Customizable

Flurbiprofen Impurity 8 CAS NO 91503-88-7

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CAS No.:91503-88-7

Grade:Pharmacy Grade

Content:99.90%

Packaging:Customizable

Azilsartan Impurity 11 CAS NO 91526-16-8

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CAS No.:91526-16-8

Grade:Pharmacy Grade

Content:99.90%

Packaging:Customizable

Nalmefene Impurity CAS NO 91598-83-3

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CAS No.:91598-83-3

Grade:Pharmacy Grade

Content:99.90%

Packaging:Customizable


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Each batch undergoes strict QC, accompanied by COA, MSDS, and full compliance with international standards.

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