Ask sales for the lot-numbered COA matched to the offered or supplied batch; it records the tests actually completed, their specifications, and the reported results.
Review the matching batch COA for the analytical scope and results recorded for that lot.
Matching batch COA available.
PCAC will review 7 peptides for the 503A bulks list, BPC-157, KPV, TB-500, MOTS-c, Emideltide, Semax, Epitalon. Read our briefing →
PCAC will review 7 peptides for the 503A bulks list. Read →
FDA PCAC reviews 7 peptides in July. Read →
Reference-code fill; Tirzepatide identity verified per batch COA · 60 mg
Overview
GLP1-T-60 is the largest fill in the Tirzepatide-class reference-code family at 60 mg lyophilized per vial. The fill size targets distributor workflows that require larger-than-standard per-vial quantities for fractionation into smaller dispensing presentations or for direct use in higher-dose research and compounding protocols. The 'T' code designation indicates Tirzepatide GIP/GLP-1 dual agonist material per the upstream supplier price-table convention; identity confirmation against the released batch COA is essential at order time. For direct procurement, the named Tirzepatide SKU with its broader 12-fill-size flexibility (2 mg through 120 mg) is generally the cleaner procurement route. Distributor buyers fractionating the T-60 fill into smaller downstream presentations should plan the fractionation workflow under sterile or near-sterile conditions: lyophilized peptide is exposed to ambient air during the fill-split step and any contamination introduced at that point compromises the subsequent fills. PeptideXpo offers optional pre-fractionation OEM service that splits the T-60 batch into smaller standardized fills under ISO 7/8 cleanroom conditions, eliminating the in-house sterile-fill burden for the buyer.
Who buys this, and why
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.
Primary buyer fit: regional distributors and re-sellers.
Specifications
Documentation available on request
Regulatory note
Reference code; verify API identity via batch-specific COA before order placement.
Frequently asked questions
GLP1-T-60 at 60 mg lyophilized per vial targets two specific workflows: (1) distributor buyers who plan to fractionate the larger batch into smaller dispensing-fill sizes under their own ISO-compliant cleanroom conditions, and (2) buyers in high-volume research or compounding contexts where the per-vial overhead amortization at 60 mg meaningfully improves cost economics versus repeated smaller orders. For buyers without in-house sterile-fill capability, PeptideXpo can pre-fractionate the T-60 batch into smaller standardized fills under ISO 7/8 cleanroom conditions as part of the OEM service, eliminating the post-purchase sterile-fill burden.
Fractionating a 60 mg lyophilized bulk vial into smaller standardized fills requires: (1) controlled-environment reconstitution of the bulk lyophilizate in a clean diluent (typically Water for Injection), (2) sterile-filtration of the reconstituted solution through 0.22 μm filters into a sterile holding vessel, (3) controlled-aliquot fill of the filtered solution into individual smaller vials under ISO 7/8 cleanroom conditions, and (4) terminal re-lyophilization in the smaller vials to produce the final dispensing format. Each step requires the buyer to have appropriate facility infrastructure and validated procedures. PeptideXpo's pre-fractionation OEM service eliminates the need for the buyer to maintain this infrastructure, particularly useful for distributors who don't operate their own sterile-fill facilities.
The pre-fractionation workflow runs through PeptideXpo's ISO 7/8 cleanroom facility: the bulk T-60 batch is reconstituted, sterile-filtered, aliquoted into the buyer's specified smaller-fill format (typically 5 mg, 10 mg, or 15 mg per smaller vial), and terminal-lyophilized. The released-batch documentation covers both the original bulk-vial QC (HPLC, mass spec, water content) and the smaller-vial release testing (sterility per USP <71>, container-closure integrity, fill-weight verification). Lead time adds approximately 1 week to the standard 14-21 day production schedule. Pricing is configured per smaller-vial output rather than per bulk T-60 input. Discuss the target fill size and quantity at quote stage to receive specific pricing.
Related peptides
GIP / GLP-1 dual receptor agonist
Reference-code fill; Tirzepatide identity verified per batch COA · 10 mg
Reference-code fill; Tirzepatide identity verified per batch COA · 30 mg