What Data is Provided on the Certificate of Analysis

Here is a summary of the information that is typically provided on the AmbioPharm certificate of analysis (CoA):

For all non-GMP grade peptides, your CoA containing information such as amino acid sequence, modifications, purity, mass spectral data, and RP-HPLC (reversed-phase high-performance liquid chromatography) data will be provided. Additional data may be reported as well, such as amino acid analysis, peptide content, bioburden, endotoxin, water content, counter ion content, etc. if these have been requested in advance as quoted services in addition to our standard package.

For GMP services, the CoA is much more comprehensive. A typical CoA for a cGMP peptide will contain the following data and customer-supplied specifications, including aspect or appearance, molecular weight by MS, purity by RP-HPLC or UPLC, specified impurities, unspecified impurities, total impurities, peptide content by elemental analysis, water content (Karl Fischer), counterion content by ion chromatography, amino acid analysis, mass balance, bioburden and endotoxin results. Other services can be requested, such as MS-MS sequencing, NMR, impurity synthesis and spiking studies, method development and validation, process development and optimization, etc.

Interested in learning more about Peptide Production? Contact Us.