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Raw material full release testing (USP/NF/EF/JP)

Compendial Raw Material Testing per USP/NF/EP/JP Standards
GMP-Compliant Analysis for Excipients & APIs in Your Supply Chain

Overview Service

Capzer Pharmaceuticals delivers full-service raw material testing for active pharmaceutical ingredients (APIs) and excipients, adhering to USP/NF, EP, JP, BP, ChP, FCC, and ACS monographs. As an FDA-registered, DEA-registered, and cGMP-compliant lab, we support formulation development, vendor qualification, and release testing to ensure material quality and regulatory compliance.​​

Our Approach

We utilize state-of-the-art instrumentation including HPLC-UV/PDA, GC-FID/MS, UPLC-MS/MS, ICP-MS, FTIR, UV-Vis, and Karl Fischer titrators for accurate identification, assay, impurity profiling, residual solvents, heavy metals, and elemental impurities. Testing follows compendial methods, client-supplied protocols, or custom-developed/validated procedures, with full data packages and Certificates of Analysis provided.

Key Capabilities

  • Quantitative assays, dissolution, and stability-indicating methods.
  • Elemental impurities (ICP-MS per USP /, EP 2.4.20), nitrosamines, and extractables/leachables.
  • Microbiology testing (microbial limits, bioburden) and on-site sampling for raw materials.​

Benefits for Partners

Partners benefit from rapid turnaround, ISO/IEC 17025 accreditation, and on-site support to meet manufacturing timelines and ANDA requirements. Our vertically integrated 20,000 sq. ft. GMP facility ensures seamless integration with formulation and stability services, reducing risks and costs for U.S.-based generic development.

Other Service

Need for help?

Our expert team is here to support you with reliable pharmaceutical testing, analytical solutions, and regulatory guidance. Whether you have a query or need a customized service, we’re ready to assist you at every step.

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