Nitrosamine Risk Assessment - APIs
Preliminary Evaluation (Q1)
API Name:
Manufacturer Details:
Q1. Is Sodium Nitrate or any other Nitrosating agents involved in the Route of Synthesis (ROS) for the API?
Yes
No
Not Sure
Q2. Is Sodium Nitrate or any other Nitrosating agents involved in the ROS for the Key Starting Material (KSM)?
Yes
No
Not Sure
Q3. Are Secondary or Tertiary Amines used in API ROS?
Yes
No
Not Sure
Q4. Are Secondary or Tertiary Amines used in API KSM ROS?
Yes
No
Not Sure
Q5. Are amide-based solvents (e.g., DMF, NMP) used in the API’s ROS?
Yes
No
Not Sure
Q6. Are amide-based solvents (e.g., DMF, NMP) used in the KSM’s ROS?
Yes
No
Not Sure
Q7. Are azides (e.g., NaN3) used in the API’s ROS?
Yes
No
Not Sure
Q8. Are azides (e.g., NaN3) used in the KSM’s ROS?
Yes
No
Not Sure
Q9. Are recovered solvents used during the API manufacturing process?
Yes
No
Not Sure
Q10. Are recovered solvents used during the KSM manufacturing process?
Yes
No
Not Sure
Q11. Is there a possibility that solvents used in the process contain triethylamine or other secondary/tertiary amines alongside nitrites?
Yes
No
Not Sure
Q12. Are third-party facilities involved in recovering solvents used for the API?
Yes
No
Not Sure
Q13. Are third-party facilities involved in recovering solvents used for the KSM?
Yes
No
Not Sure
Q14. Are nitrosating agents used in any other product/process at the API site?
Yes
No
Not Sure
Q15. Are nitrosating agents used in any other product/process at the KSM site?
Yes
No
Not Sure
Q16. Are secondary/tertiary amines used in any other process at the API site?
Yes
No
Not Sure
Q17. Are secondary/tertiary amines used in any other process at the KSM site?
Yes
No
Not Sure
Q18. Are amide-based solvents (e.g., N,N-DMF, NMP) used in any other process at the API site?
Yes
No
Not Sure
Q19. Are amide-based solvents (e.g., N,N-DMF, NMP) used in any other process at the KSM site?
Yes
No
Not Sure
Q20. Is water used in the manufacturing process?
Yes
No
Not Sure
Q21. Are there other risks of nitrosamine presence in API process?
Yes
No
Not Sure
Q22. Risk of NDSRI: Does the API has secondary/tertiary amine functional group and nitrites are involved in manufacturing process?
Yes
No
Not Sure
Q23. Risk of NDSRI: Can degradation of starting materials, intermediates or API produce secondary/tertiary amine functional groups with nitrites present in the manufacturing process?
Yes
No
Not Sure
Q24. Risk of NDSRI: Is formation of any NDSRI listed as per USFDA Guidance: Control of Nitrosamines in Human Drugs or EMA / CMDh: Appendix 1 for Nitrosamines possible in API/KSM process?
Yes
No
Not Sure
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