1. ICH. Technical
and Regulatory Considerations for Pharmaceutical Product Lifecycle
Management, Q12, Step 2, November 2017. https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q12/Q12_Draft_Guideline_Step2_2017_1116.pdf (accessed June 14, 2019).
2. ICH. Assessment
and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals
to Limit Potential Carcinogenic Risk, M7(R1), Current Step 4 version,
March 2017. https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Multidisciplinary/M7/M7_R1_Addendum_Step_4_2017_0331.pdf (accessed June 14, 2019).
3. Risk Assessment of Genotoxic Impurities in New Chemical Entities: Strategies To Demonstrate Control
4. ICH. Stability Testing of New Drug
Substances and Products, Q1A(R2), Current Step 4 version, February 2003.https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q1A_R2/Step4/Q1A_R2_Guideline.pdf (accessed June 14, 2019).
5. Effect of Temperature and Relative Humidity on Nitrazepam Stability in Solid State