N-Nitroso Abacavir Impurity possibility in physical state as standard

Guidance, Documents, Resources
1

Hello everyone,

N-Nitroso Abacavir is listed in the US Guidance with AI 1500 ng/day. However, the said impurity is not easily available through non-pharma impurity suppliers. Some says this impurity synthesis is not possible due to very unstable material whereas some says it is available and provided to many of pharma customers. So little confusion over here. Pls shar your experience related to the same.

Thank you in advance for the suggestion/sharing the experience.

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2

Are you sure the information about availability is reliable, many times they offer in their website as available but that just trigger their synthesis attempt!

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The supplier claims it has synthesized the said impurity 3-4 times and many customers are using the same. However, reliability for any non-pharma impurities is always a question especially in the case of NDSRI.