Identity, strength, quality, and purity of a drug product.
Sampling plan and acceptance criteria required by USP XXII/NF XVII for
content uniformity testing [905]
dissolution testing [711]
disintegration testing [701]
Approximate probabilities can be computed for passing USP testing.
Acceptance limits also can be established to pass USP testing with a high probability.
Tolerance limit approach can be used to set up the in-house specifications.
