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Testing of nitrosamine impurities in pharmaceuticals & finished products (in any dosage forms)

Nitrosamine Impurities Testing
cGMP LC-MS/MS & GC-MS Analysis per FDA/USP Guidance​

Overview Service

Capzer Pharmaceuticals offers specialized nitrosamine impurities testing for APIs, excipients, and finished products across all dosage forms including tablets, capsules, liquids, and creams. Our FDA/DEA-registered laboratory ensures compliance with FDA guidance on NDMA, NDEA, NMBA, and other N-nitrosamines to <18 ng/day AI limits.​​

Our Approach

Utilizing validated LC-MS/MS, UPLC-MS/MS, and GC-MS methods, we detect and quantify nitrosamines at ppb levels following USP <1469> and Procedure 1/3 protocols. Sample extraction optimizes recovery for complex matrices, with full risk assessment support for ANDA filings and stability monitoring.​​

Key Capabilities

  • Detection of 7+ nitrosamines (NDMA, NDEA, NDIPA, NEIPA, NDBA, NMBA, NPYR).
  • Method development/validation for client-specific APIs like sartans and metformin.
  • Routine screening for raw materials, in-process, and commercial release.​​

Benefits for Partners

Partners receive regulatory-ready CoAs confirming nitrosamine control, supporting Gabapentin commercialization and Empagliflozin pipeline ANDAs from our ISO 17025-accredited facility. This mitigates recall risks while accelerating generic approvals.

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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