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Release of Critical Raw Materials
QC Testing Attributes
Our QC team analyzes and releases final Critical Raw Material grade products according to pre-established product specification sheet which identifies the attributes and their acceptance criteria. Our QC also offers a large variety of optional QC methods as listed below.
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 composing the peptide product is performed |
Identity by Peptide Sequence Analysis | High Resolution Mass Spectrometry (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 compose 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