Physico-chemical control requires the use of appropriate analytical methods adapted to each product. For this purpose, during the pharmaceutical development phase, it is necessary to develop these methods to ensure that they are appropriate and reliable.
To ensure consistency of dosage units, each unit in a batch must have an active substance content within a narrow range around the label claim. According to chapters <905> Uniformity of Dosage Unit of the USP and 2.9.40. Uniformity of Dosage Unit of the European Pharmacopoeia to ensure maximum regulatory compliance. Analytical methods are developed based on the characteristics of the active substance and depending on the dosage form.
This test is provided to determine compliance with the dissolution requirements for orally administered solid dosage forms. According to chapters <711> Dissolution of the USP and 2.9.3 Dissolution test for solid dosage forms of the European Pharmacopoeia. The analytical methods are developed on the basis of the specific characteristics of the active substance and depending on the dosage form.
Development of liquid chromatography techniques. Specification of active ingredients and finished products according to ICH Q3A and Q3B criteria.
Validation of an analytical method is the process by which it is established through laboratory studies that the performance characteristics of the method meet the requirements for the intended analytical applications. Method validation is performed according to ICH Q2(R1) by protocol development, reporting and generation of all primary data.
A documented process verifying that a receiving laboratory is able to reproduce the results obtained with an analytical method validated by a sending laboratory.