Quality & Compliance
Every PurelyAminos product undergoes rigorous multi-step quality verification before release. Our processes meet ISO 9001 standards with full traceability from raw material to final shipment.
ISO 9001 Certified
Our quality management system meets ISO 9001:2015 standards, ensuring consistent process control across all synthesis and testing operations.
HPLC Purity Analysis
Every lot is analyzed by reverse-phase HPLC. We report purity as % area and retain raw chromatogram data for each batch.
Mass Spectrometry ID
Identity is confirmed by ESI-MS for every product. Observed and theoretical molecular weights are reported on each COA.
Certificate of Analysis
Full COA included with every shipment, documenting identity, purity, lot number, synthesis date, and storage conditions.
Tested in the USA
All testing and quality verification is performed at US-based laboratories by qualified analytical chemists.
Cold-Chain Shipping
Lyophilized peptides ship with insulated packaging and cold packs to maintain integrity throughout transit.
Our Quality Process
Raw Material Sourcing
Protected amino acids and reagents are sourced from verified suppliers with full documentation of origin and purity.
Solid-Phase Peptide Synthesis
Peptides are assembled using Fmoc SPPS on automated synthesizers with inline monitoring at each coupling step.
Cleavage & Deprotection
Side-chain protecting groups are removed under controlled conditions to yield crude peptide with full sequence integrity.
Purification (RP-HPLC)
Crude peptide is purified by preparative reverse-phase HPLC to achieve ≥95% or ≥99% purity depending on grade.
Identity Verification (ESI-MS)
Every purified lot is analyzed by electrospray ionization mass spectrometry to confirm molecular identity.
Purity Analysis (Analytical HPLC)
Final purity is quantified by analytical RP-HPLC with UV detection. Raw data retained on file.
Lyophilization
Peptide solution is lyophilized under sterile conditions to produce a stable, dry powder with low moisture content.
COA Generation & Batch Release
A Certificate of Analysis is generated, reviewed by QC, and attached to the final product before shipment.
Release Specifications
| Parameter | Standard Grade | High-Purity Grade |
|---|---|---|
| Purity (HPLC) | ≥95% | ≥99% |
| Identity (MS) | ESI-MS confirmed | ESI-MS confirmed |
| Form | Lyophilized powder | Lyophilized powder |
| Counterion | Acetate (TFA-free) | Acetate (TFA-free) |
| Moisture content | ≤8% | ≤5% |
| Storage | −20 °C | −20 °C or −80 °C |
Regulatory Compliance
Research Use Only (RUO)
All products are designated RUO and are not intended for diagnostic, therapeutic, or clinical purposes. Not FDA approved.
Purchaser Responsibility
Buyers are responsible for compliance with all applicable local, state, and federal laws governing the purchase and use of research reagents.
Full Traceability
Each batch is assigned a unique lot number with full records retained, including synthesis data, QC results, and shipping information.