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.

Rac-Erythro-Dihydro Bupropion Hydrochloride CAS NO 80478-43-9

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CAS No.:80478-43-9

Grade:Pharmacy Grade

Content:99.90%

Packaging:Customizable

Ambrisentan Impurity 7 CAS NO 80532-84-9

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CAS No.:80532-84-9

Grade:Pharmacy Grade

Content:99.90%

Packaging:Customizable

n-(2-Hydroxyethyl)-n-Carboxymethylnitrosamine CAS NO 80556-89-4

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CAS No.:80556-89-4

Grade:Pharmacy Grade

Content:99.90%

Packaging:Customizable

Fenticonazole Impurity B Nitrate CAS NO 80639-95-8

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CAS No.:80639-95-8

Grade:Pharmacy Grade

Content:99.90%

Packaging:Customizable

Fenticonazole Ep Impurity C CAS NO 80676-29-5

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CAS No.:80676-29-5

Grade:Pharmacy Grade

Content:99.90%

Packaging:Customizable

Nifedipine Pyrimidine Impurity CAS NO 80742-11-6

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CAS No.:80742-11-6

Grade:Pharmacy Grade

Content:99.90%

Packaging:Customizable

Nifedipine Impurity 21 CAS NO 80742-13-8

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CAS No.:80742-13-8

Grade:Pharmacy Grade

Content:99.90%

Packaging:Customizable

Rufinamide 2,6-Didesfluoro Impurity CAS NO 80819-65-4

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CAS No.:80819-65-4

Grade:Pharmacy Grade

Content:99.90%

Packaging:Customizable

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