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P3X Labs

Quality & Certifications

Every P3X Labs batch meets pharmaceutical-grade standards before it ships.

Our Certifications

ISO 9001:2015
GMP Certified
FDA Registered
USP/EP Standards

Certification Details

ISO 9001:2015

International Organization for Standardization

ScopeQuality Management System — entire production and QC chain
Review cycleAnnual external audit

Ensures every process from synthesis to shipment follows a documented, auditable quality management system. External auditors verify compliance annually against the ISO standard.

GMP Certified

Good Manufacturing Practice

ScopeFacility, equipment, personnel, and batch records
Review cycleContinuous — batches not released until GMP criteria are met

Manufacturing practices that guarantee consistency and quality in every batch. Covers raw material sourcing, in-process controls, environmental monitoring, and finished product release.

FDA Registered

U.S. Food & Drug Administration

ScopeResearch compound manufacturing facility registration
Review cycleAnnual registration renewal

Our facility is registered with the FDA as a research compound manufacturer. This registration is maintained annually and confirms that our facility is known to and visible to U.S. regulators.

USP/EP Standards

United States / European Pharmacopeia

ScopeAnalytical methods, reference standards, and purity thresholds
Review cycleOngoing — applied to every batch

Testing methods and purity thresholds adhere to pharmacopeial standards — the same reference methods used by licensed pharmaceutical manufacturers worldwide. Results are reported using pharmacopeial notation on every COA.

What It Means For You

What These Standards Mean

Certifications are only meaningful when they translate into verifiable outcomes. Here is what our standards produce in practice — on every order, every batch.

  • Every batch tested by an independent, accredited laboratory before shipment
  • HPLC and mass spectrometry confirm identity and ≥99% purity on every lot
  • Full Certificate of Analysis (COA) linked to each vial via scannable QR code
  • Lot-level traceability from synthesis to delivery in canonical FDT-YYYY-NNNNNN format
  • Temperature-controlled packaging meets USP storage requirements for lyophilized peptides
  • Endotoxin testing (LAL assay) on every batch — EU/mg results reported on COA

Scan any vial to verify its COA

Every vial ships with a lot number in FDT-YYYY-NNNNNN format and a QR code linking directly to the batch COA.

Shop Verified Compounds

For Research Use Only. Products are not for human or veterinary consumption. Not a drug, dietary supplement, or medical device. Sold exclusively to qualified research professionals.