Nitrosamines risk assessments for Topical herbal extracts

Risk Assessment Strategy / Tools & Technology
1

Dear all,

We are working in our pharmaceutical factory on topical product including herbal extracts as Sandal wood oil , etc) .

My Question is; Is it enough to ask for Declaration from the supplier of these extracts or request nitrosamines risk assessments from them?.

The other question; is there any upcoming nitrosamines guidance about topical products (Creams and gels including herbal extracts) ?.

My regards,

2

The Regulatory Authorities make no distinction between oral and topical products when it comes to nitrosamine risk.
However I did an assessment for nitrosamine presence in a large number of herbal raw materials and the vast majority do not present any risk

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