Compliance-first peptide distribution
Stratum Peptide supplies pharmacy-grade peptides and APIs to licensed 503A and 503B pharmacies, telehealth providers, and longevity clinics — released lot by lot against a published Certificate of Analysis and full panel of HPLC, MS, endotoxin, and chain-of-custody records.
Why a regulated channel, right now
The FDA is removing compounded GLP-1s from the shortage list, and state attorneys general are pursuing mislabelers. Peptide Sciences and Paradigm Peptides are out of the market. Surviving demand is consolidating around operators who can prove provenance — lot by lot.
Five inspection layers
Each layer assumes the prior one passed. We do not release a lot on identity alone, and we do not release on purity alone — the panel has to close before anything ships.
HPLC retention time + mass-spectrometry molecular ion
Confirms the peptide is what the label says it is — not a near-isobar or a relabeled research powder.
Catches — Mislabeled APIs, lot substitution, salt-form drift between manufacturing sites.
Area-% against an internal reference standard
Chromatogram released with every lot. Area-% purity, not a “≥95% tested” line buried in a PDF.
Catches — Impurity carryover, residual synthesis byproducts, degradation before release.
Full MS trace, observed vs theoretical m/z
Observed mass within tolerance of theoretical. Every batch trace is published — not just retained on file.
Catches — Sequence variants, missing residues, oxidation, acetylation drift.
LAL endotoxin (EU/mg), Class 2 residual solvents (ICH Q3C)
Endotoxin and RS panels run by the same accredited lab that ran identity. Both panels ship in-box.
Catches — Gram-negative contamination, retained DMF/DCM/ACN above USP limits — common in offshore APIs.
Manufacturing site → receiving → QC release → ship-out
Every vial traces to a manufacturing site, a receiving inspector, a release signature, and a hand-off timestamp.
Catches — Reintroduced returns, undocumented repacking, post-release relabeling for the “research-use” channel.
Twice released, never approximated. Identity and release both run on the same ISO/IEC 17025 accredited panel. The same lab, the same signature path, the same documentation packet.
Every-release documentation
The packet below ships with every lot — physical with the vial, archived against the lot record on our server, and attached to your receiving record when you scan it in.
Documented before what leaves the warehouse.
Each lot release is treated like a construction closeout: spec, deviation log, and clean hand-off before anything ships. No silent corrections, no missing signatures.
All method files public on request.
Who we license to
We deliberately narrow the channel. Every license is checked before an account opens, and re-checked annually. The fact that the buyer list is short is the product.
503A compounding pharmacies
Filling legitimate patient prescriptions for semaglutide, tirzepatide, and other indicated APIs.
503B outsourcing facilities
High-volume compounders operating under cGMP with sterile fills.
Telehealth providers
Practitioners prescribing under a documented patient relationship — not “research-peptide” DTC storefronts.
Regenerative-medicine clinics
Sourcing BPC-157, GHK-Cu, and thymosin alpha-1 for documented clinical protocols.
Sports-medicine practices
Running valid CJC-1295 / ipamorelin protocols under practitioner oversight.
Not licensed to ship to
We do not resell offshore imports relabeled “not for human consumption.” Every order ships from a U.S. climate-controlled facility with documented handling.
Procurement
503A / 503B pharmacies, telehealth providers, and clinics: send us your license and the peptides you’re sourcing. We reply with a procurement brief — current lot IDs in release, expected delivery, and negotiated pricing for recurring orders.
Direct line
stratum-peptide@polsia.app
We respond to inbound license review within one business day. Please include your pharmacy or clinical license, schedule, and the peptides you’re sourcing.