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Peptide Purity & Characterization

ISO 17025 accredited COAs for research peptides, compounding pharmacies, and peptide therapeutics programs — RP-HPLC purity, LC-MS/MS identity, and MS/MS sequence verification.

ISO 17025 Accredited RP-HPLC Purity LC-MS/MS Identity MS/MS Sequencing ICH Q3A/Q3B USP <85> Endotoxin
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~⅓
of commercial peptides fail label claims
$350–900
per sample (purity to full impurity profile)
5–7 bd
standard turnaround; rush available
ISO 17025
accredited COA, accepted by all retailers
FDA 503B
compliant documentation for compounders
⚠️

FDA enforcement is accelerating. Independent audits in 2024–2025 found that approximately one-third of commercially available research-grade peptides fail their label claims for purity or identity. FDA's heightened enforcement actions on 503B compounding pharmacies producing peptide injectables — semaglutide analogs, BPC-157, TB-500, and others — are creating urgent demand for ISO 17025-accredited third-party COAs that can withstand regulatory scrutiny. A supplier with an accredited purity COA is no longer a differentiator; it is quickly becoming a baseline expectation.

Test Panels

Comprehensive Peptide Testing Menu

From basic purity screening to full regulatory-grade characterization packages. Mix and match panels to match your documentation requirements.

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Purity + Identity COA

$350 – $500 / sample

The baseline accredited COA for research peptide suppliers and catalog providers. RP-HPLC quantitation with LC-MS identity confirmation.

  • RP-C18 gradient, UV detection at 214 nm (peptide bonds) and 280 nm (aromatic residues)
  • % purity by area normalization with USP <621> chromatography framework
  • LC-MS full scan for exact molecular weight confirmation ± 1 Da
  • Major impurity identification (mass only)
  • Pass/Fail against client-specified purity threshold
  • Signed ISO 17025-accredited COA with calibration traceability
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Sequence Verification (MS/MS)

$400 – $600 / sample

Sequence-level confirmation via LC-MS/MS fragmentation on the Sciex 4500. b/y ion series interpreted against reference sequence or by de novo analysis.

  • LC-MS/MS full scan + targeted MS/MS fragmentation
  • b-ion and y-ion series mapped to primary sequence
  • Sequence confirmation report with fragment assignment table
  • Detects sequence scrambling, deletions, or substitutions
  • Ideal for peptide therapeutics CROs and IND-enabling studies
  • Can be bundled with purity panel (combo rate available)
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Full Impurity Profile

$600 – $900 / sample

Comprehensive related substances analysis with MS identification of individual impurity identities. Meets ICH Q3A/Q3B thresholds for drug-grade submissions.

  • Gradient LC-UV quantitation of all related substances above 0.05% threshold
  • LC-MS identification of each impurity (deletion sequences, racemization products, oxidized species)
  • ICH Q3A/Q3B reporting thresholds applied and flagged
  • Acceptance criteria aligned with FDA 503B compounding requirements
  • GMP-adjacent documentation package
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Endotoxin Screen (Add-On)

$150 – $250 / sample

Required for injectable peptide products. Bacterial endotoxins test per USP <85>. Commonly bundled with the purity or impurity profile for compounding pharmacy clients.

  • LAL (Limulus Amebocyte Lysate) method
  • USP <85> Bacterial Endotoxins Test
  • Gel-clot or kinetic turbidimetric method
  • Results in EU/mL with Pass/Fail vs. client threshold
  • Mandatory for 503B compounding pharmacy submissions
Analytical Method

RP-HPLC + LC-MS/MS Platform

The same instrument platform used in peptide pharmaceutical QC — applied to research peptide and compounding pharmacy testing with full ISO 17025 traceability.

ChromatographyReversed-phase C18 (RP-HPLC), gradient elution
Mobile phase0.1% TFA or formic acid in water/acetonitrile
UV detection214 nm (peptide bond) + 280 nm (Trp/Tyr/Phe)
Mass spectrometerSciex 4500 triple quadrupole LC-MS/MS
MS scan modesFull scan (Q1), MS/MS (Q3) for fragmentation
Sequence coverageb/y ion series, de novo or reference-matched
Mass accuracy± 1 Da (Q1 full scan); sub-Da with IS correction
Purity frameworkUSP <621> liquid chromatography
Impurity thresholdsICH Q3A/Q3B reporting/identification limits
EndotoxinLAL, USP <85> Bacterial Endotoxins Test
Sciex 4500 LC-MS/MS instrument at Prodigy Labs
How It Works

From Sample Receipt to COA

A four-step process from sample intake through accredited report delivery.

1

Sample Intake

Ship lyophilized or solution-phase peptide (≥ 1 mg recommended). Intake form captures sequence, expected MW, purity target, and intended use. Rush samples flagged at intake.

2

Sample Preparation

Dissolve in appropriate solvent (water, DMSO/water, ACN/water). Centrifuge and filter for particulates. Prepare at appropriate concentration for UV linearity range.

3

Chromatographic Analysis

RP-HPLC gradient run with UV detection. Peak integration, purity calculation by area normalization. System suitability checked per USP <621> before sample injection.

4

Mass Spec Confirmation

LC-MS full scan for molecular weight confirmation. MS/MS fragmentation for sequence verification (if requested). Impurity masses identified by exact mass search.

5

COA Generation & Review

Accredited COA generated with analyst signature, instrument calibration data, reference standard traceability, and Pass/Fail determination. Delivered as signed PDF.

Regulatory Context

Standards & Frameworks

The regulatory landscape driving demand for accredited peptide COAs — and the standards our methods are designed around.

FDA 503B Compounding Pharmacies

FDA's CDER enforcement program targets 503B outsourcing facilities producing peptide injectables. Outsourcing facilities must demonstrate sterility, purity, and potency with third-party COAs. ISO 17025 documentation is the accepted standard.

ICH Q3A / Q3B Impurities

ICH Q3A (new drug substances) and Q3B (new drug products) define reporting, identification, and qualification thresholds for related substance impurities. Prodigy's impurity profiling panel applies these thresholds to classify and report each impurity.

USP <621> Chromatography

USP <621> governs liquid chromatography system suitability requirements (theoretical plates, tailing factor, resolution, repeatability). Our RP-HPLC methods are validated to USP <621> acceptance criteria before each sample run.

USP <85> Bacterial Endotoxins

Required for all injectable and parenteral peptide products. The LAL-based endotoxin test determines bacterial endotoxin units (EU/mL or EU/mg) against USP <85> acceptance criteria. Essential for 503B compounding pharmacy submissions.

ICH Q6B Specifications

ICH Q6B defines specification-setting principles for biotechnological/biological products, including peptides. Applies to identity, purity, potency, and quantity testing. Our COA format is aligned with Q6B documentation requirements.

ISO 17025 Accreditation

Our laboratory operates under ISO 17025 quality management requirements — the international standard for testing laboratories. Accredited COAs carry a level of third-party validation that non-accredited lab reports cannot provide to regulatory reviewers.

Who We Serve

Target Clients

From research-grade suppliers to IND-enabling CROs — if your peptide needs an accredited COA, this is the workflow.

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Research Peptide Suppliers

Differentiate catalog listings with ISO 17025-accredited COAs. Command premium pricing. Win accounts from buyers who can no longer accept unaccredited supplier data.

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503B Compounding Pharmacies

FDA-compliant documentation for semaglutide analogs, BPC-157, TB-500, PT-141, and other peptide injectables. Endotoxin + purity + identity bundled in one accredited package.

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Peptide Therapeutics CROs

IND-enabling purity and sequence verification for early-stage peptide drug candidates. Full impurity profiling to ICH Q3A/Q3B thresholds with drug regulatory documentation.

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Academic Core Facilities

Rapid purity verification for synthesized peptides. Cost-effective QC before downstream biological experiments. COA documentation for grant reports and publications.

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Biotech Drug Discovery

Sequence verification for novel therapeutic peptide candidates. Identity confirmation during lead optimization. Impurity identification to guide synthetic chemistry optimization.

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Peptide API Suppliers

Certificate of Analysis documentation for pharmaceutical ingredient sales. Full impurity profiles and stability-indicating method development for drug master file submissions.

What You Receive

COA Deliverables

Every report is signed, dated, and accreditation-stamped. Full traceability from instrument calibration to final result.

Ready to Submit Samples?

Contact us to discuss your testing requirements, confirm turnaround time, and receive a sample submission form.

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