Non-Compendial Methods

Analytical methods which are not provided in US pharmacopoeia are non-compendial methods. These methods are product specific and need to be developed based on the critical quality attributes of the product. A few examples of non- compendial methods include spectroscopic, chromatographic, electrophoretic, etc. methods. These non-compendial methods help to develop the test methods for identity, purity, quantity, impurities and potency.