Dear Experts,
Greetings!
I am seeking guidance on analytical methodologies and method validation strategies for determining isotopic purity, isotopic enrichment, and deuterium content (%D) in deuterated compounds.
If available, could you please share any relevant:
-
USP/Ph. Eur./JP or other pharmacopeial guidance
-
Regulatory guidance documents
-
Scientific publications or literature references
-
Analytical protocols or validation approaches
-
Practical experiences and best practices
Your valuable suggestions and insights would be highly appreciated.
Thank you in advance for your support.
Best regards,
Gautam G. Halder