3 In the Drugs and Cosmetics Rules, 1945 - amam-ayurveda.org

172.6. 2.6. Stability Studies (for details refer Appendix IX)Final release specificationReference standard characterizationMaterial safety data sheet2.7. 2.7. Data on FormulationDosage formCompositionMaster manufacturing formulaDetails of the formulation (including inactive ingredients)In process quality control checkFinished product specificationExcipient compatibility studyValidation of the analytical methodComparative evaluation with international brand(s) or approved Indian brands, ifapplicablePack presentationDissolutionAssayImpuritiesContent uniformitypHForce degradation studyStability evaluation in market intended pack at proposed storage conditionsPacking specificationsProcess validationWhen the application is for clinical trials only, the international non-proprietary name (INN)or generic name, drug category, dosage form and data supporting stability in the intendedcontainer-closure system for the duration of the clinical trial (information covered in item nos.2.1, 2.3, 2.6, 2.7) are required.3. 3. Animal Pharmacology (for details refer Appendix IV)