Peptide Analysis Services

Effective Characterization of peptide therapeutics at each step of manufacturing is necessary to minimize lot-to-lot variation in product quality. Ensuring the quality and equivalence between generic and brand name peptide drug products raises a number of challenges and those challenges differ according to the type of peptide drug. To prove the pharmaceutical equivalence of such synthetic peptides with the innovator drugs (Synthetic or rDNA origin), it is required to have a thorough understanding of advanced analytical and bioanalytical tools. At Energon, we use scientific excellency of experienced team and hyphenated analytical tools to Characterize the product. We believe to be “An extension of your own laboratory”, help you in successful ANDA submission and product commercialization.

  • Key Peptide Services
      • Molecular weight analysis by HRMS
      • Amino acid sequencing by HRMS
      • Peptide mass finger printing by HPLC/ UHPLC
      • Related substances by HPLC/HRMS
      • Process related impurities by HPLC/Ion chromatography
      • HMW Impurities/Oligomers/Aggregates by SEC-HPLC UV
  • Peptide Impurities

    • Possible impurities during the synthetic process of a therapeutic peptide include Deletion sequences, Incomplete deportation sequences, Sequence with amino acid modifications, Cleaved sequences and Amino- acid racemization. Some impurities may arise during storage due to degradation mechanisms such as β-elimination and succinimide formation.

      There are chances of other Impurities like peptide counter ions and trifluoroacetate arise from purification methods or SPPS. The side chain reactions of amino acids from deamidation, oxidation, and hydrolysis reactions result in the formation of impurities. Excipient interactions also generate peptide-related impurities.

      Well characterized high-quality impurity standards of synthetic peptides are utmost important to judge the quality of the product. At Energon, we can help you with synthesis of any impurities with greater purities.
  • Peptide Synthesis & Starting material (SMs)

    • We make AAD’s with utmost quality at an affordable cost that can be used as SMs for your peptide API. Having sound experience with AAD’s and other starting material, we also provides quality API with highest possible purity.
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