Our Quality Promise
At CertaPeptides, quality is not just a claim — it is the foundation of everything we do. Our multi-step quality assurance process ensures that every peptide we deliver meets the highest standards of purity and consistency required for rigorous scientific research.
Five-Point Testing Protocol
Every batch undergoes five independent analytical tests before release. No batch ships until all five tests pass our acceptance criteria.
1. HPLC Purity Analysis
Method: Reverse-phase HPLC with C18 column, UV detection at 220nm wavelength. Gradient elution with acetonitrile/water mobile phase containing 0.1% TFA.
Acceptance criteria: ≥98% purity minimum, with our standard production consistently achieving ≥99%. The chromatogram must show a single dominant peak with clearly resolved impurity peaks below 1% each.
What this tells you: HPLC separates the target peptide from synthesis byproducts — truncated sequences, deletion peptides, racemized forms, and degradation products. A purity ≥99% means the vast majority of the material in your vial is the correct, full-length peptide.
2. Mass Spectrometry (ESI-MS)
Method: Electrospray ionization mass spectrometry (ESI-MS) with confirmation of observed molecular weight ±0.1% of theoretical value.
Acceptance criteria: Observed MW must match theoretical MW within instrument tolerance. For example, BPC-157 (theoretical MW: 1419.53 Da) must show an observed peak at 1419.5 ± 1.4 Da.
What this tells you: Mass spectrometry confirms molecular identity. Even if HPLC shows 99% purity, without MS you cannot be certain that the 99% is the correct peptide. MS verification eliminates the risk of mislabeled or substituted compounds.
3. Amino Acid Analysis (AAA)
Method: Acid hydrolysis followed by derivatization and chromatographic quantification of individual amino acids.
Acceptance criteria: Observed amino acid ratios must match the theoretical sequence composition within ±10% for each residue.
What this tells you: AAA provides an independent confirmation of peptide composition. While MS confirms total molecular weight, AAA verifies that each individual amino acid is present in the correct ratio — catching errors that might produce the right MW but wrong sequence.
4. Endotoxin Testing (LAL)
Method: Limulus Amebocyte Lysate (LAL) kinetic turbidimetric assay per USP <85> guidelines.
Acceptance criteria: <1.0 EU/mg (endotoxin units per milligram). This threshold is suitable for most in vitro and in vivo research applications.
What this tells you: Bacterial endotoxins (lipopolysaccharides) are potent immune activators that can confound research results, particularly in cell culture and animal studies involving immune or inflammatory pathways. LAL testing ensures your peptide will not introduce endotoxin artifacts into your experiments.
5. Bioburden Testing
Method: Membrane filtration method per USP <61> with aerobic plate count and fungal enumeration.
Acceptance criteria: Total aerobic microbial count <100 CFU/g; total yeast and mold count <10 CFU/g.
What this tells you: Bioburden testing confirms that the lyophilized peptide has acceptably low microbial contamination, ensuring research integrity for cell culture and animal model work.
Certificate of Analysis (COA)
Every order includes a batch-specific COA containing: HPLC chromatogram with retention times and peak integration data, MS spectrum showing observed vs. expected molecular weight, amino acid analysis ratios, endotoxin test result, bioburden test result, net peptide content, appearance and solubility description, batch/lot number for full traceability, date of manufacture and analysis, and storage recommendations.
COAs are available upon request for any batch — current or historical. We retain all analytical records for a minimum of 5 years.
Storage, Handling & Shipping
All peptides are lyophilized (freeze-dried) using controlled slow-freeze protocols that preserve peptide structure and maximize reconstitution recovery. Products ship in sealed, amber-tinted or light-protected vials with flip-off caps, desiccant packets, and tamper-evident seals.
Long-term storage: -20°C (freezer), stable for 24+ months when kept sealed and dry.
Short-term storage: 2-8°C (refrigerator), stable for 6+ months.
Reconstituted storage: 2-8°C, use within 30 days. Always reconstitute with bacteriostatic water for multi-use protocols.
Supply Chain & Traceability
We source from GMP-certified and ISO 9001-compliant synthesis facilities. Every batch number links to a complete chain of documentation: synthesis records, raw material certificates, analytical test results, packaging records, and shipping logs. This end-to-end traceability means any quality question can be investigated back to the point of synthesis.
Questions about our quality processes? Contact our research support team at research@certapeptides.com.