API described in a pharmacopoeia:
Tests and limits should, as a minimum, comply with relevant pharmacopoeial requirements.
Provide a copy of the monograph together with any test methods referenced but not duplicated in the monograph.
Provide details of any specifications additional to those in the pharmacopoeia.
Provide certificates of analysis for at least two batches produced at each site of manufacture by each synthetic method, including results for impurities.
API not described in a pharmacopoeia:
A list of tests and limits for results for the API is needed.
Include test methods in sufficient detail for them to be replicated by another laboratory.
Results of validation of the methods for assay of the API and of impurities are needed.