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.
FDA PCAC reviews 7 peptides for the 503A bulks list (BPC-157, KPV, TB-500, MOTs-C, Emideltide, Semax, Epitalon). Read our compounder's decision tree. Read our briefing →
FDA PCAC reviews 7 peptides for the 503A bulks list in July. Read →
FDA PCAC: 7 peptides under review. Read →
GLP-1 receptor agonist
Vialdyne primary owner
This is the primary page for buyers qualifying Semaglutide through a pharmacy QA lens. It focuses on batch documentation, sterile-compounding add-ons, formulation route questions, and destination-market review rather than general catalog assortment.
Overview
Semaglutide is the workhorse 31-amino-acid GLP-1 receptor agonist of the current era. Two engineered substitutions (Aib at position 8, Arg at position 34) plus a γGlu-2xOEG-linked C18 fatty-diacid on Lys26 give the molecule its DPP-4 resistance and reversible albumin binding, which together produce the once-weekly PK profile. The same API underpins three approved finished products: subcutaneous Ozempic for T2DM, subcutaneous Wegovy for chronic weight management, and oral Rybelsus paired with SNAC absorption enhancer, plus the corresponding EU equivalents. For compounding pharmacy buyers, every Vialdyne lot of Semaglutide acetate is released against a ≥99.0% HPLC main-peak specification. The standard batch packet includes RP-HPLC peak integration, ESI-MS within 0.5 Da of the 4113.58 g/mol average, Karl Fischer water, and counter-ion quantitation. For 503A and 503B sterile-compounding scope, LAL endotoxin per USP <85> and microbial limits per USP <61>/<62> are validated add-on tests on the same lot, no re-sampling, and the documentation supports both EU GMP Annex 1 aseptic-process expectations and US 503B outsourcing-facility QA files. Seven standard fill strengths from 2 to 50 mg map onto pilot, weekly dispensing, and small-batch outsourcing workflows. For practitioners building CagriSema-style fixed combinations, use the dedicated co-lyophilised CagriSema SKU rather than mixing two reconstituted vials, the amylin component is surface-active in dilute aqueous solution and the co-lyophilised cake preserves the released ratio.
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 Semaglutide, every lot HPLC-verified. These are previews — request the full high-resolution certificate for any lot.
VerifiedRequest full COA →Semaglutide
VD260428-SM177 · 99.45%
VerifiedRequest full COA →Semaglutide
VD260428-SM178 · 99.25%
VerifiedRequest full COA →Semaglutide
VD260428-SM179 · 99.34%
VerifiedRequest full COA →Semaglutide
VD260428-SM175 · 99.47%
VerifiedRequest full COA →Semaglutide
VD260428-SM180 · 99.50%
VerifiedRequest full COA →Semaglutide
VD260428-SM176 · 99.34%
Regulatory note
Semaglutide reaches patients as several FDA-approved finished products, namely Ozempic, Wegovy, and Rybelsus. The active on its own, though, has not made the 503A bulks list this cycle. Because compounding eligibility follows the destination market's shortage status and regulatory stance, it falls to buyers to confirm this at the point of dispense.
Selected literature
Frequently asked questions
Three engineered features carry the PK profile. Position 8 carries an Aib substitution (in place of Ala) that blocks the standard DPP-4 cleavage site. Position 34 carries Arg in place of Lys, which keeps off-target lipidation out of the synthesis step. And Lys26 carries the load-bearing modification: a C18 fatty-diacid attached through a γGlu-2xOEG spacer, which mediates reversible albumin binding and extends half-life from the minutes-scale of native GLP-1 to roughly seven days. Tirzepatide and Retatrutide were designed using the same general lipidation playbook, but with different fatty-acid chain lengths and slightly different linker geometries.
The API is identical across all three approved finished products; the formulation chemistry is what changes. The subcutaneous presentations (Ozempic, Wegovy) deposit Semaglutide directly into adipose tissue, where the albumin-binding kinetics give predictable absorption. The oral presentation (Rybelsus) co-formulates Semaglutide with SNAC (sodium N-(8-[2-hydroxybenzoyl]amino)caprylate), a permeation enhancer that locally raises gastric pH, briefly increases gastric epithelial permeability, and shields the peptide from proteolysis long enough for transcellular absorption. The pharmaceutical-grade active released by Vialdyne is suitable for compounding into either route, subject to the receiving pharmacy's own stability work and any state-board route-specific compounding rules.
For multi-dose vial workflows, reconstitute in bacteriostatic water for injection (BWFI); for single-use sterile prep, use sterile water for injection (SWFI). The cake will go into solution within about a minute with a gentle swirl; never vortex, the resulting foam entrains air and accelerates surface-mediated aggregation, which can show up as a slow potency loss that the standard release HPLC will not flag. Working solutions should be sub-divided immediately into single-use aliquots and held at -20 C. In compounding-pharmacy use, the freeze-thaw cycle count is the dominant operational driver of measured-potency loss, slow temperature drift is a much smaller contributor, so the practical rule is: thaw once, dispense, and refreeze the residual no more than twice.
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Long-acting amylin analog
