Attributes Testing
Appearance Visual inspection is performed on the final lyophilized product to confirm characteristics of color and form. White to off white powder/solid is typical, but some products contain color, particularly dye-labeled peptides or stand-alone dyes
Identity by Mass Spectrometry Confirmation of the molecular weight of final product is performed and compared to its theoretical molecular weight
Identity by Amino Acid Analysis Qualitative and quantitative confirmation of the amino acids comprising the peptide product is performed
Identity by Peptide Sequence Analysis High Rresulution Mass Spectromerty (HR-MS) or equivalent are used to Confirm the peptide sequence.
Peptide Purity by HPLC Analysis Purities range from 95.0-99.0% depending on customer request and the product’s development phase
Peptide Content by CHN analysis Peptide content is dependent on the product characteristics, including the amino acids that comprise the peptide sequence
TFA Content TFA content is dependent on the peptide sequence. Typically a low ppm will result if Acetate or Chloride is chosen as the counter ion
Water Content Confirmation of the water content is determined for batch to batch consistency and product mass balance
Solubility The optimal solvent for a peptide is dependent on its amino acid sequence. Testing is performed in a specific set of solvents
Endotoxin Per USP guidelines
Bioburden Per USP guidelines
Residual Solvents (ACN, DMF & DCM) Per USP guidelines
Enantiomeric Purity Qualitative and quantitative confirmation of L and D amino acids is performed
Volatile matter content Confirmation of volatile matter in product and mass balance is performed
Metal Content Per ICH guidelines
Counter Ion Content Acetate or Chloride

Additional testing available upon request

Are you planning a GMP project?

Let's talk about your requirements

Contact us