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GMP-compliant manufacturing, ISO 17025 third-party testing, and a lot-specific Certificate of Analysis with every order. The documentation clinical practices and compounding pharmacies require.
GMP Compliant
Documented manufacturing at every stage
ISO 17025 Tested
Accredited third-party verification
COA Every Order
Lot-specific documentation with every shipment
Manufacturing Standards
Every production lot follows documented Good Manufacturing Practice procedures — from raw amino acid sourcing through final lyophilization and packaging — with full batch records maintained for supply chain traceability.
GMP Compliant
Documented manufacturing procedures at every stage
In-House Analytics
RP-HPLC and ESI-MS on every production lot
Cold-Chain Logistics
Temperature-controlled from manufacture to delivery
Batch Documentation
Full batch records for supply chain traceability
Controlled Access
Clean room environments with monitored controls
Independent analytical testing follows ISO 17025-accredited laboratory protocols. Every production lot is verified by reversed-phase HPLC for purity quantification and ESI-MS for molecular identity confirmation. The resulting lot-specific Certificate of Analysis accompanies every order — not a generic batch document, but a record tied to the specific lot number in your shipment.
Synthesis occurs in monitored clean room environments with documented temperature, humidity, and particulate controls. Standard operating procedures govern every production phase: reagent preparation, solid-phase synthesis, cleavage and deprotection, purification, lyophilization, and packaging. These controls give compounding pharmacies and clinical practices the documentation foundation their compliance workflows require.
99%+
Purity Guarantee
RP-HPLC verified on every production batch
Every peptide that ships from Peptari meets the 99%+ purity threshold — verified by reversed-phase HPLC on the specific lot in your order. This is not a batch average or a certificate from a similar compound. It is documentation from your exact shipment.
Every Batch Tested
No batch ships without a passing HPLC result. No exceptions.
Lot-Specific COAs
Every order includes a Certificate of Analysis tied to the specific lot number.
Retained Samples
Reference samples retained for 24 months for independent re-verification.
Step 1 — HPLC Analysis
Reversed-phase high-performance liquid chromatography (RP-HPLC) is the analytical standard for peptide purity verification. The technique separates the target peptide from synthesis impurities based on differences in molecular polarity, using a C18 stationary phase and an aqueous-organic mobile phase gradient.
UV detection at 220nm — the characteristic absorbance wavelength of the peptide bond — generates a chromatogram where each compound appears as a distinct peak at its retention time. The sharper and more isolated the target peak, the higher the sample purity.
Result output
The chromatogram provides a quantitative purity percentage — the proportion of target peptide relative to all detected compounds. This value appears on every lot-specific COA.
Sample Preparation
Peptide sample dissolved in mobile phase solvent system at precise concentration
Column Separation
Injected into C18 reversed-phase column; compounds separate by hydrophobicity
Gradient Elution
Increasing organic solvent concentration elutes compounds at characteristic retention times
UV Detection at 220nm
Peptide bond absorbance measured at 220nm; chromatogram peak generated per compound
Purity Calculation
Target peak area divided by total detected area yields purity percentage — must meet 99%+ threshold to ship
Electrospray Ionization
Peptide sample ionized via electrospray; charge states generated for detection
Mass-to-Charge Analysis
Ion trap measures mass-to-charge ratio (m/z) with high precision across multiple charge states
Molecular Weight Calculation
Observed molecular weight calculated from m/z spectrum and deconvolved charge state distribution
Identity Confirmation
Observed molecular weight compared against theoretical — agreement within 0.1 Da confirms correct peptide sequence
Step 2 — Mass Spectrometry
While HPLC measures how pure a sample is, ESI-MS (electrospray ionization mass spectrometry) confirms what it is. A sample can be 99% pure but be the wrong compound. Mass spectrometry eliminates this possibility by comparing the measured molecular weight against the theoretical weight of the peptide sequence.
The ESI-MS process ionizes the peptide and measures its mass-to-charge ratio with high precision. Agreement between observed and theoretical molecular weight — typically within 0.1 Da — provides definitive identity confirmation independent of the HPLC purity measurement.
Two tests. One certainty.
HPLC quantifies purity. Mass spectrometry confirms identity. Together, they verify both the composition and the correct compound.
< 1 EU/mg
Endotoxin threshold — LAL assay verified
Step 3 — Endotoxin Testing
Limulus Amebocyte Lysate (LAL) assay — standard part of every production lot, not an add-on option
Beyond Purity
Endotoxins — bacterial lipopolysaccharides released during cell lysis — are not detected by HPLC. A sample can pass purity testing at 99%+ and still carry significant endotoxin contamination. For research applications involving cell culture, animal models, or injection-based protocols, endotoxin levels are a critical quality parameter.
The Limulus Amebocyte Lysate (LAL) assay is the industry-standard method for endotoxin detection. The assay exploits the clotting cascade of horseshoe crab blood cells, which react to even trace levels of bacterial endotoxin. Results are reported in endotoxin units per milligram (EU/mg).
Most research-use-only peptide suppliers stop at HPLC purity. Peptari performs LAL endotoxin testing as a standard part of our quality protocol — not as an add-on or premium option.
Independent Verification
Clinical practitioners and compounding pharmacies require more than a supplier's word on purity. Peptari submits production samples to independent third-party laboratories for verification — an unaffiliated analytical team with no commercial interest in the results. Every lot is eligible for independent review, and third-party COA data is available upon request for any lot number.
Independent verification follows ISO 17025-accredited analytical methods: reversed-phase HPLC for purity quantification and ESI-MS for molecular identity confirmation. Results are cross-referenced against in-house data. This dual-layer verification structure gives your compliance team documentation from two independent sources for any lot in your supply chain.
ISO 17025-Accredited Methods
All third-party testing conducted under ISO 17025-accredited analytical protocols — the international standard for testing laboratory competence.
Independent analytical laboratory (name disclosed upon request)
Third-party results are available upon request for any lot number in your order history.
Dual-layer verification
In-house QC + independent third-party review. Two independent sources of documentation for every lot in your supply chain.
Reading a COA
We don't just provide COAs — we help you understand them. Below is a sample COA with annotations explaining each field.
PEPTARI RESEARCH
Certificate of Analysis
Product Information
Test Results
For Research Use Only — Not for Human or Veterinary Use
Authorized: [Lab Director Signature]
Identity
The full chemical name and common name of the peptide. This confirms the product matches what was ordered.
Sequence Verification
The single-letter amino acid sequence confirms the peptide was synthesized with the correct primary structure.
Lot Traceability
Every production batch receives a unique lot number. This enables full traceability from synthesis to shipment.
Production Date
The manufacturing date anchors the stability window and helps determine shelf life for storage planning.
Visual QC
A visual inspection confirms expected physical characteristics. Discoloration or unusual texture indicates potential degradation.
Primary Purity Metric
Reversed-phase HPLC quantifies the proportion of target peptide relative to all detected compounds. This is the primary quality metric.
Identity Confirmation
Mass spectrometry measures the molecular weight. Agreement with theoretical weight confirms the correct compound was synthesized.
Microbial Safety
The LAL assay detects bacterial endotoxins not visible on HPLC. Critical for cell culture and in vivo research applications.
Handling Instructions
Recommended storage conditions to maintain stability and prevent degradation of the lyophilized product.
Every Peptari order ships with a lot-specific COA. Request a sample to see our documentation firsthand.