Login / Register Order My Items
Contact Us
800.227.0627
Contact Us Quote Order Login / Register

Peptide Release QC Testing Services

Fast, compliant release testing for peptides—covering identity, purity/impurities, safety testing, residuals, counterion exchange/analysis, and complete CoA for research, diagnostic, and therapeutic development workflows.

Contact Us Speak to a Scientist
ISO 13485 support GLP documentation support ICH Q2 (R2) method options USP/EP-aligned testing (as applicable) LC/MS & peptide mapping
Talk to a chemist Request a quote
Overview At-a-Glance Panels Methods & Instrumentation Advanced Workflows Release Criteria How it Works Contact

Comprehensive Peptide Release & Analytical Verification

Our Peptide Release QC program delivers fast, compliant testing across identity, purity/impurities, residuals, counterion composition, and safety attributes. Panels are tailored to your specification and documentation needs for RUO, diagnostic, and therapeutic development workflows.

Audit-ready peptide release testing
Identity & Structure
LC–MS (ESI), HRMS, MS/MS, peptide mapping (as needed)
Purity & Impurities
RP-HPLC / UHPLC, orthogonal methods, CE (as applicable)
Residuals & Elemental
GC solvents, ICP-MS metals, elemental analysis
Counterions & Moisture
Counterion exchange + analysis; Karl Fischer water
LC–MS system used for peptide release QC testing

High-resolution LC–MS instrumentation for identity confirmation and impurity profiling.

Standard Panels

Standard
Non‑GMP QC Panel
  • Identity: LC–MS (ESI)
  • Purity: RP‑HPLC / UHPLC
  • Quantitation: UV (as applicable)
  • Counterion check (project-dependent)
  • Optional: CE, MS/MS, impurity profiling
Enhanced
Release Panel (ISO 13485 / GLP Support)
  • Identity: LC–MS (intact) ± MS/MS or mapping (as needed)
  • Purity: HPLC with impurity reporting
  • Residual solvents (GC), metals (ICP‑MS) as required
  • Water (Karl Fischer), pH & appearance
  • Endotoxin (LAL), bioburden (as required)
Custom
Method Transfer & Validation Options
  • Client method transfer + verification
  • Fit-for-purpose testing plans
  • ICH Q2(R2) validation elements (accuracy, precision, linearity, range, robustness)
  • Custom impurity targets & orthogonal methods
  • Stability-indicating method options

Panel composition and deliverables are defined by peptide type, modifications, intended use, and your specifications.

Methods & Instrumentation

Category Primary Methods Purpose
Identity LC–MS (ESI), HRMS; MS/MS; peptide mapping (as needed) Confirm molecular weight and identity; verify sequence/structure when required.
Purity RP‑HPLC / UHPLC, orthogonal HPLC; CE (as applicable) Quantify main peak vs. impurities; profile related substances.
Impurities / Residuals GC (residual solvents), ICP‑MS (metals), elemental analysis Assess solvent carryover and elemental impurities (as required).
Composition Counterion exchange; counterion analysis; water (Karl Fischer) Meet formulation/spec needs for counterions and moisture content.
Safety LAL endotoxin, bioburden testing Demonstrate microbial control for applicable workflows.
Advanced Chiral purity analysis, capillary electrophoresis, peptide mapping Orthogonal characterization for complex peptides and modified systems.

Techniques vary by sequence, length, modifications (labels, linkers, non‑natural AAs), and intended use.

Proven Peptide Analytical Workflows

Beyond routine release panels, we support advanced characterization workflows commonly used for peptide therapeutics— including semaglutide and tirzepatide programs—covering purity/impurity resolution, sequence confirmation, stress testing, and purification scale‑up.

Below are examples of the types of studies and method packages we can execute (project-dependent).

Purity analysis
High-resolution separations for modified peptides and peptide agonists
  • HILIC analysis of peptide receptor agonists
  • In‑depth analysis of semaglutide (peptide receptor agonist)
  • Efficient method optimization for semaglutide analysis
  • Analysis of a synthetic peptide and its impurities (LC‑UV / LC‑MS workflows)
  • Molecular weight confirmation using MS spectral deconvolution
Impurity analysis
Low-level impurity confirmation and forced-degradation profiling
  • Advanced LC/MS workflow for semaglutide and impurity characterization
  • Impurity profiling of tirzepatide under stress conditions
  • Orthogonal confirmation of peptide-related impurities (intact mass)
  • Stability‑indicating method options for degradant separation
Sequence confirmation
Mapping and advanced fragmentation for confident sequence assignment
  • Comprehensive characterization of multiple peptide analogs
  • Identification of amino acid isomers using electron capture dissociation (ECD)
  • Advancing chromatographic performance in peptide mapping
  • MS/MS sequence confirmation (project-dependent)
Stability & forced degradation
Stress testing and stability assessment for peptide therapeutics
  • Forced degradation impurity analysis of peptide agonists
  • Peptide drug stability analysis (time/temperature/light as applicable)
  • Enhanced peptide characterization and stability assessment
  • Trend reporting and comparability support (scope-dependent)
Purification workflows
From analytical scouting to preparative purification and scale-up
  • Optimizing analysis and purification of a synthetic peptide using PLRP‑S columns
  • Efficient purification of synthetic peptides at high and low pH
  • Preparative purification planning aligned to your target purity and yield
  • Fraction re-analysis and confirmation by LC‑MS / HPLC (as applicable)
Ask about advanced workflow support

Want this section to match your internal menu exactly? Send your full peptide QC test list and we’ll align naming, grouping, and report deliverables.

Release Criteria (Examples)

Attribute Typical Spec Method
Identity Intact mass matches expected ESI LC–MS
Purity ≥ 85–98% main peak (program-dependent) RP‑HPLC / UHPLC
Residual Solvents Meets target limits (as applicable) GC
Elemental Impurities Meets target limits (as applicable) ICP‑MS / Elemental
Counterion Content Report / meets target range Counterion analysis
Endotoxin Target EU/mg (use‑case dependent) LAL
Bioburden Acceptance per plan Culture / USP methods (as applicable)
Water Content Report or target range Karl Fischer

Final specs are set per program needs, intended use, and regulatory strategy.

How Release QC Works

1
Scope & Quote
Share target specs, peptide format, and use-case. We return a tailored panel, timeline, and quote.
2
Sample Receipt
Chain-of-custody, storage needs, and lot metadata verified on intake.
3
Testing & Review
Trained analysts execute methods; second-person review and documentation checks (scope-dependent).
4
Report & CoA
Methods, chromatograms/spectra, calculations, and pass/fail vs. specs (as applicable).

What Sets Us Apart

  • Flexibility: From rapid feasibility QC to enhanced release documentation and stability support.
  • Breadth: Modified peptides, labeled peptides, difficult sequences, and orthogonal analytics.
  • Counterion control: Counterion exchange and quantitative counterion analysis for spec alignment.
  • Regulatory alignment: ISO 13485 and GLP support with audit-ready documentation (scope-dependent).
  • Customization: Method transfer, fit-for-purpose plans, and validation options (project-dependent).
Stability Studies

Accelerated and long-term study planning with stability-indicating method options and summary reporting.

Request a Study Plan
Analytical Method Development & Validation

Scouting → optimization → transfer → fit-for-purpose / ICH Q2(R2) validation elements with protocols and reports.

Discuss Your Method
Peptide Manufacturing

Custom peptides from research through diagnostic and therapeutic workflows with documentation support.

Explore Peptides

Start Your Peptide Release QC

Send us your peptide sequence, scale, and required specifications. A scientist will recommend the most appropriate QC panel, documentation package, and turnaround timeline.

Contact Us Speak to a Scientist

FAQ

What is included in peptide release QC?

Typical panels include identity (LC–MS; MS/MS or mapping as needed), purity with impurity profiling, residual testing (solvents/metals), counterion exchange/analysis where required, safety testing (endotoxin/bioburden for applicable workflows), and a signed CoA against predefined specifications.

How are specifications defined?

We start from typical ranges based on peptide type and intended use, then finalize specifications with you to reflect risk, formulation, and program strategy.

Do you support counterion exchange and confirmation?

Yes. We can exchange TFA to alternative counterions (e.g., acetate or chloride) and confirm counterion content via quantitative analysis.

What sample amount do I need?

Many panels can be run with ≥ 200 μg. Expanded residual/elemental or advanced characterization may require more—ask for study-specific guidance.

How fast is turnaround?

Standard panels are commonly completed in 3–7 business days depending on scope and queue. Larger or custom panels may require additional time.

More FAQ'sAll FAQ's

Why Choose Bio-Synthesis

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

Greetings Researchers,

Please be advised that any information, guidelines, writeups, and oral/video/graphic content on our website are intended solely as general guidelines.
It is the researcher's sole responsibility to conduct thorough research on the designs of the products intended for their experiments before submitting
their designs to Biosynthesis for review of production feasibility.
Thank you for your understanding.

Quick Links