ABSTRACT
Sterile products: Reasonable intervals must be outlined in the stability procedure for sampling and testing of small volume parenterals for strength, appearance, colour, particulate matter, pH, sterility and pyrogenicity. Injectables, which are intended for use as an additive to another drug product, will also be tested for the possibility of incompatibilities. In order to ensure container/closure integrity parenterals will be stored inverted or on their sides and then must be
Designation: Department: Date:
tested for container/closure integrity at speci”c intervals throughout the stability study.
