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COA and QC Purification for Purified Peptides

COA and QC Purification for Purified Peptides

Fit-for-purpose analytics and documentation aligned with GLP / ISO 13485 quality systems (non-GMP).

Purification is only useful when you can verify what you received. We provide clear analytical evidence for identity and purity, packaged in a Certificate of Analysis (COA) and supporting data set.

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What’s in the COA QC methods Traceability Related pages

What you receive (COA)

  • Sample identification and traceable lot labeling
  • Purity statement based on analytical HPLC
  • Identity confirmation summary (MS, as scoped)
  • Key method notes and results summary

COA scope is tailored to your project. If you have internal templates or reporting conventions, we can align the output format to your requirements.

Non-GMP: GLP / ISO 13485 aligned documentation. GMP manufacturing is not offered.

QC methods (fit-for-purpose)

  • Analytical HPLC: purity assessment, peak profile review
  • Mass spectrometry: identity verification and mass confirmation (as scoped)
  • Optional project add-ons: additional characterization as needed (case-by-case)

If your peptide has known risks (oxidation, multiple isomers, co-elution), we design QC to detect those risks.

Traceability & controlled workflows

  • Controlled documentation and recordkeeping
  • Sample custody and labeling discipline
  • Instrument maintenance and method record retention
  • Change awareness if method conditions must be adjusted

Related purification pages

RP-HPLC

Ion-Exchange (IEX)

HILIC

Desalting / SEC

Purification Overview

Why Choose Bio-Synthesis

Trusted by biotech leaders worldwide for over 45+ years of delivering high quality, fast and scalable synthetic biology solutions.