What the label states, the lot delivers — net peptide mass, not gross powder weight, purity reported as measured rather than rounded up, and a Certificate of Analysis for every lot.
Net peptide mass, not powder weight; purity as measured, not rounded up; a COA per lot.
Net peptide + purity not rounded up. COA per lot.
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GIP / GLP-1 dual receptor agonist
Vialdyne primary owner
This is the primary portfolio page for buyers who need Tirzepatide release documentation, destination-market review, and pharmacy-style supplier qualification before pricing. The page should answer whether the batch packet, add-on tests, fill ladder, and regulatory posture are sufficient for the buyer's own QA file.
Overview
For 503A patient-specific compounders and 503B outsourcing facilities, Tirzepatide arrives as a fully-characterised 39-residue GIP / GLP-1 balanced dual agonist API. The defining structural feature is a C20 fatty-diacid attached to a lysine side chain, which mediates reversible serum-albumin binding and locks in the once-weekly PK that separates this molecule from the earlier GLP-1 mono-agonist generation. The same active drives the FDA-approved finished products Mounjaro (T2DM) and Zepbound (chronic weight management); the API supplied here is the upstream feedstock, not a finished dosage form. Every Vialdyne lot of lyophilised Tirzepatide acetate is released at ≥99.0% HPLC main-peak area, with a batch COA bundling RP-HPLC peak integration, ESI-MS identity within 0.5 Da of the 4813.45 Da theoretical, Karl Fischer water determination, and counter-ion quantitation. LAL endotoxin per USP <85>, microbial limits per USP <61>/<62>, and full LC-MS/MS sequence confirmation are available as documented add-ons on the same lot and are the recommended scope when qualifying a new supplier for sterile compounding. The fill ladder spans 2 mg to 120 mg across twelve nominal strengths so a single qualified supplier covers everything from pilot work to weekly dispensing inventory; sterile-filled presentations and pre-blended Tirzepatide + Cagrilintide co-lyophilisates can be arranged under a project-specific change-control with full ICH-Q1A stability commitment.
Applications & buyer fit
Most buyers in this category are 503A and 503B compounding pharmacies fulfilling metabolic and weight-management protocols, plus research labs investigating GLP-1 / GIP / GCG receptor pharmacology. The procurement decision usually hinges on three things: documented purity at scale, a regulatory team that can respond on destination-market questions in writing, and the ability to supply consistent counter-ion form (acetate by default) across recurring orders.
Sourced for
Buyer fit
Documentation that ships
Procurement note: Supplied as a documented active in acetate counter-ion form by default; the buyer verifies current scheduling and compounding eligibility for the destination market.
Primary buyer fit: 503A / 503B compounding pharmacies and academic and contract research laboratories.
Specifications
Certificate of Analysis
Published released-batch COAs for Tirzepatide, every lot HPLC-verified. These are previews — request the full high-resolution certificate for any lot.
VerifiedRequest full COA →Tirzepatide
VD260428-TR216 · 99.32%
VerifiedRequest full COA →Tirzepatide
VD260428-TR208 · 99.50%
VerifiedRequest full COA →Tirzepatide
VD260428-TR217 · 99.25%
VerifiedRequest full COA →Tirzepatide
VD260428-TR209 · 99.62%
VerifiedRequest full COA →Tirzepatide
VD260428-TR210 · 99.51%
VerifiedRequest full COA →Tirzepatide
VD260428-TR206 · 99.61%
VerifiedRequest full COA →Tirzepatide
VD260428-TR211 · 99.36%
VerifiedRequest full COA →Tirzepatide
VD260428-TR212 · 99.45%
VerifiedRequest full COA →Tirzepatide
VD260428-TR213 · 99.63%
VerifiedRequest full COA →Tirzepatide
VD260428-TR207 · 99.43%
VerifiedRequest full COA →Tirzepatide
VD260428-TR214 · 99.50%
VerifiedRequest full COA →Tirzepatide
VD260428-TR215 · 99.57%
Regulatory note
As a finished drug, Tirzepatide is FDA-approved and marketed under Mounjaro and Zepbound. What we supply, however, is the pharmaceutical-grade active for research and, where local rules allow, for formulation by compounding pharmacies. That active does not presently appear on the 503A bulks list. Whether it may be compounded turns on the destination market's shortage status and regulatory stance at the moment of dispensing, and confirming that at dispense time is the buyer's responsibility.
Selected literature
Frequently asked questions
The CAS Registry number is 2023788-19-2, molecular formula C225H348N48O68, average MW 4813.45 g/mol. Structurally it is a 39-amino-acid sequence carrying a C20 fatty-diacid albumin-binder on a lysine side chain. The full identity stack (sequence, CAS, formula, theoretical MW, isotope envelope) is reproduced on every released batch COA and on the SDS.
Receptor scope is the headline difference: Semaglutide is a selective GLP-1 mono-agonist, whereas Tirzepatide is a balanced co-agonist of GIP and GLP-1 receptors. The backbone is also longer (39 residues vs 31), and the lipidation chemistry differs, Tirzepatide uses a C20 diacid, Semaglutide a C18 diacid, with related but distinct linker geometry. Both are dosed once-weekly because both rely on albumin-binding for half-life extension; the dual-receptor mechanism is what produces the larger HbA1c and body-weight reductions seen in head-to-head Phase 3 readouts.
Acetate is the standard counter-ion released from our process. Compounding pharmacies should default to acetate because residual TFA from older purification routes is documented to confound cell-based potency assays and is harder to clear from the final dosage form. TFA-salt material is available only on explicit written request with a documented downstream need, and the lot certificate will flag the counter-ion change for the pharmacy's QA file.
Twelve nominal strengths are catalogued: 2, 5, 10, 15, 20, 30, 40, 50, 60, 80, 100, and 120 mg. The 5-20 mg fills are the workhorses for 503A patient-specific compounding because they map cleanly onto the typical reconstitution-and-aliquot worksheets; the 40-120 mg fills support 503B batch dispensing and weekly clinic inventory builds. Custom strengths, ISO-class sterile fills, and co-lyophilised Tirzepatide + Cagrilintide presentations are scoped under a separate change-control with stability commitment per ICH-Q1A.
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