Provide the results of stability testing of the API.
Describe the methodology used during stability studies; if this is identical to methodology described elsewhere in the data set, a cross-reference will suffice. If different methodology was used, provide validation of tests for impurities and assay and for other tests as necessary.
For well established API, studies should be conducted according to WHO1 Guidelines. For new API and products, ICH2 guideline should be used. Results should be included for physical as well as chemical tests, e.g., (where relevant) particle size and polymorph form.
1 WHO Expert Committee on Specifications for Pharmaceutical Preparations, Thirty-fourth report. Geneva, World Health Organization, 1996: 65-79 (WHO Technical Report Series, No 863).
Indicate the proposed shelf-life (or retest date) that is justified by the stability testing.