Research-use-only analytical standards

99.59% median purity, proven on every lot.

Live from 444 COAs and 251 lots — 15 tests on every new batch at independent labs, leftover TFA measured, not assumed. Every result lands on that batch's own Certificate of Analysis.

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The quality program · cGMP-aligned manufacturing

From synthesis to certificate.

Finished product is made by contract manufacturers under quality-managed systems. Our leverage is the release program: every new batch is accepted or rejected on 15 tests at U.S. ISO/IEC 17025 labs, and every result is published; earlier batches show their own count. Here is the whole path.

How our testing got here →

SourcingQualified supplier · incoming QC

01 Peptide API & incoming QC Synthesized at a qualified supplier, which checks the raw peptide on receipt: identity, purity, net peptide content, endotoxin. Our own testing starts on the finished product. Proof: Supplier CoA + incoming QC

PreparationClassified cleanrooms

02 Component prep Type I glass washed and depyrogenated by dry heat; sterile lyophilization stoppers, dried and validated. Proof: Validation summary
03 Compounding API dissolved in Water for Injection in a closed, sanitized vessel; bioburden checked before filtration. Proof: Batch record

Aseptic coreSterile core · ISO 5

04 Sterile filtration Redundant 0.22-micron sterilizing-grade filters, integrity-tested before and after every batch. Proof: Filter integrity records
05 Aseptic fill Filled under unidirectional ISO 5 airflow with every fill weight verified; stoppers part-seated for drying. Proof: Media-fill summary
06 Lyophilization A formulation-specific freeze-dry cycle; stoppered inside the chamber under sterile nitrogen, before the vial ever leaves the core. Proof: Cycle + moisture record

FinishingControlled environment

07 Cap & crimp Aluminum overseal crimped under a Grade A air supply; seal force checked. Proof: Batch record
08 100% inspection Every single vial inspected for particulates, container defects and cake quality. Proof: Inspection record
09 Closure integrity Deterministic container-closure integrity testing confirms the seal holds all the way to you. Proof: CCIT report

Independent verificationISO/IEC 17025 labs

10 QC release & lot CoA The layer we own outright: independent testing at accredited U.S. labs — sterility (USP <71>), endotoxin (USP <85>) and the full panel — landing on a public, per-lot Certificate of Analysis. Read every certificate →

The quality-systems layer runs through every stage: executed batch records, continuous environmental monitoring, aseptic process simulations, and QA review with formal change control.

Sterile lyophilized peptide vial: rapidly frozen, vacuum-dried, aseptically filled, and sealed under a crimped cap

444 independent lab reports published
3,444 vials tested, every one third-party
239 / 239 lots passed sterility — zero failures
0 limits exceeded across 96 metal & 108 solvent screens — worst reading ever: 0.01% of its limit

Chromatographic purity, 251 lots 99.59% median

98% lowest lot 98.22% 100%

Reports released, last 12 months

Tested at Vanguard Laboratory · Eagle Analytical Services Inc. + 2 more Read every certificate

Each step answers to a test

Did the fill stay sterile? Sterility at two independent labs — USP <71> and ScanRDI · 239 / 239 lots pass
Did the seal hold? Container-closure integrity by dye ingress, every lot
Did synthesis leave anything behind? Residual solvents by GC-MS, residual TFA by ion chromatography
Is the cake right? Reconstitution check, and HPLC assay against the label claim