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COA & Specification Consistency Checker

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Methods and source records

These links document the calculation conventions or laboratory context. They do not validate a catalog lot or replace a controlled laboratory method.

  1. 01

    ICH Q2(R2): Validation of Analytical Procedures

    International Council for Harmonisation. Final guideline covering analytical procedure fitness, identity, assay, purity and impurity measurements.

    Technical source
  2. 02

    ICH Q6A: Specifications

    International Council for Harmonisation. Guideline on specifications, test procedures and acceptance criteria for drug substances and products.

    Technical source

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