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.

2-Butanone, 4-(Methylnitrosoamino)- (9Ci) CAS NO 87425-67-0

Unit Price:Get Price

CAS No.:87425-67-0

Grade:Pharmacy Grade

Content:99.90%

Packaging:Customizable

Diltiazem Ep Impurity B CAS NO 87447-47-0

Unit Price:Get Price

CAS No.:87447-47-0

Grade:Pharmacy Grade

Content:99.90%

Packaging:Customizable

Benzylpenicillin Impurity 14 CAS NO 87492-68-0

Unit Price:Get Price

CAS No.:87492-68-0

Grade:Pharmacy Grade

Content:99.90%

Packaging:Customizable

Topiroxostat Impurity 15 CAS NO 87544-86-3

Unit Price:Get Price

CAS No.:87544-86-3

Grade:Pharmacy Grade

Content:99.90%

Packaging:Customizable

Alpha-Hydroxybetaxolol CAS NO 87549-35-7

Unit Price:Get Price

CAS No.:87549-35-7

Grade:Pharmacy Grade

Content:99.90%

Packaging:Customizable

Ibuprofen Ester Impurity CAS NO 87553-98-8

Unit Price:Get Price

CAS No.:87553-98-8

Grade:Pharmacy Grade

Content:99.90%

Packaging:Customizable

Clodronate Impurity D CAS NO 87591-00-2

Unit Price:Get Price

CAS No.:87591-00-2

Grade:Pharmacy Grade

Content:99.90%

Packaging:Customizable

Nifedipine Impurity 9 CAS NO 87625-92-1

Unit Price:Get Price

CAS No.:87625-92-1

Grade:Pharmacy Grade

Content:99.90%

Packaging:Customizable

Go to Page

Why choose US

Trusted Manufacturer

With our own production facilities, we ensure consistent quality, reliable supply, and full traceability.

Rigorous Quality Assurance

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

Advanced R&D Expertise

Our in-house lab drives process innovation, new product development, and tailored synthesis solutions.