1. Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances;ICH Q6A,1999
2. Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Biotechnological/Biological Products;ICH Q6B,1999
3. Code of Federal Regulations. 210 and 211: Food and Drug Administration – Current Good Manufacturing Practice in Manufacturing, Processing, or Holding of Drugs; General and Current Good Manufacturing Practice for Finished Pharmaceuticals.
4. Code of Federal Regulations. Title 21, Part 58: Food and Drug Administration –Good Laboratory Practice for Nonclinical Laboratory Studies, Vol. 1.
5. Stability Testing of New Drug Substances and New Drug Products;ICH Q1A(R2),2003