Project Description

Large Pharma Mfg needs Singapore FDA GLP Analytical Chemistry Laboratory for Melamine Testing to Risk for Melamine Contamination, August

Assumptions:
-Limit test for presence of melamine and major analogues in both API/raw materials and excipients (limit: 2.5 ppm)
-Testing and validation per cGMP
-Testing by LC/MS/MS or other suitable technique
-Test with positive and negative controls in each analysis to reduce per method validation

Requested Quotations:
-per material test method development/validation
-per sample pricing for 1-5 and
1-10 concurrent samples

Reference: FDA Guidance for Industry, Pharmaceutical Components at Risk for Melamine Contamination, August 200