Operating to GMP & ICH Q7 standards across all manufacturing sites
Investor Relations Global Offices
Guide · 7 min read · By Global Biotech Laboratories Scientific Team · August 2026

Controlling deletion & related impurities in peptide synthesis

Every synthetic peptide carries impurities. Controlling them — at the source and in purification — is what separates dependable material from a roll of the dice.

No peptide synthesis is perfectly efficient, so impurities are a fact of life. The difference between a reliable supplier and an unreliable one is not whether impurities form — it is how rigorously they are prevented, removed and characterized. Here is how impurity control actually works.

Where impurities come from

  • Deletion sequences: an incomplete coupling leaves a chain missing one residue — the most common impurity.
  • Truncation: chains that stop growing entirely.
  • Side reactions: oxidation, aspartimide formation, racemization and incomplete deprotection.
  • Cleavage artefacts: adducts formed during resin cleavage and deprotection.

Preventing impurities at the source

The cheapest impurity is the one never formed. Optimised coupling chemistry, double couplings for difficult positions, appropriate reagents, and in-line monitoring all push couplings toward completion — the rationale behind automated synthesis platforms with controlled cycles. Sequence-specific risks (such as aspartimide-prone motifs) are managed with tailored conditions.

Key point: impurity control is designed in during synthesis, then verified during purification — not bolted on at the end.

Removing what remains

Impurities that do form are separated by preparative HPLC, where closely-related deletions are the hardest to resolve and drive the purity-versus-yield trade-off behind purity grades.

Characterizing and specifying

What you cannot measure you cannot control. Orthogonal analytical sciences — HPLC for purity, mass spectrometry to identify each impurity — let you set and defend a specification, which becomes critical as material moves toward GMP grade and regulatory filings.

FAQ

Peptide impurities — common questions.

What are deletion sequences in peptide synthesis?

Deletion sequences are peptide chains missing one or more residues, formed when a coupling step is incomplete. They are the most common impurity in solid-phase peptide synthesis and are closely related to the target, making them the hardest to remove.

How are peptide impurities controlled?

Impurities are controlled by preventing them during synthesis (optimised couplings, double couplings, monitoring), removing them by preparative HPLC, and characterizing them with orthogonal analytics so a specification can be set and defended.

Why does impurity characterization matter for GMP?

For GMP and regulatory filings, each significant impurity must be identified, quantified and controlled to a specification, which requires orthogonal analytical methods such as HPLC and mass spectrometry.

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