SPSFAM Meeting eBook March 2017

3/8/2017

SMPR Key Challenges

• Liquid and solid products will require different  ranges and system suitability requirements. • Alignment on definition of PACs. • Determined methods would only focus on solubles. • ID method would only focus on A‐type detection. • Reference materials and standard compounds may  be difficult. • ID specificity my be limited due to methods  available.

Comments Submitted

• (1) Quantitation – "Syrups" have not been separately identified as  a dietary supplement matrix in any of the other  dietary supplement SMPRs. No change to SMPR  proposed. • (2) Identification – "Syrups" have not been separately identified as  a dietary supplement matrix in any of the other  dietary supplement SMPRs.  No change to  SMPR proposed.

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