# ANDAs: Stability Testing of Drug Substances and Products - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/andas-stability-testing-of-drug-substances-and-products/c3403aba-7f4f-4aa1-9f7b-94ae55a3486f

> FDA guidance document: ANDAs: Stability Testing of Drug Substances and Products. Issue date: June 20, 2013. Get complete insights and analysis.

---

## Details

- Title: ANDAs: Stability Testing of Drug Substances and Products
- Communication Type: Guidance Document
- Product Type: drugs
- Office Name: Center for Drug Evaluation and Research
- Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c
- Issue Date: 2013-06-20
- Last Changed: 2020-05-06
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2012-D-0938">FDA-2012-D-0938</a>

## Related Documents

- [ANDAs: Impurities in Drug Substances:  Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/andas-impurities-in-drug-substances-guidance-for-industry/f8f33332-d6b5-44e6-a308-aa86ea6fa74f)
- [ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers](https://www.globalkeysolutions.net/guidances/guidance-document/andas-stability-testing-of-drug-substances-and-products-questions-and-answers/4506feda-4fad-4c68-a272-c1ce936ba67d)
- [Tablet Scoring:Nomenclature, Labeling, and Data for Evaluation](https://www.globalkeysolutions.net/guidances/guidance-document/tablet-scoringnomenclature-labeling-and-data-for-evaluation/d4b6bb69-1a24-4ebd-be2e-a80b08473b39)