What's on the label is the measured result — net peptide mass, not gross powder weight, plus RP-HPLC purity, on a lot-numbered COA for every batch.
Net peptide mass and RP-HPLC purity — a lot-numbered COA for every batch.
Net peptide mass + HPLC purity, per lot.
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 →
Type A neurotoxin · heavily regulated biological
Overview
Botulinum Toxin Type A is a 150 kDa zinc-metalloprotease neurotoxin produced by Clostridium botulinum, and one of the most potent biological toxins known by mass. The molecule consists of a heavy chain that binds to and is internalized by motor-neuron presynaptic terminals at the neuromuscular junction, and a light chain that proteolytically cleaves SNAP-25 (a SNARE protein required for acetylcholine vesicle docking), thereby blocking neurotransmitter release. The therapeutic application uses controlled local injection of dilute neurotoxin to produce localized chemodenervation lasting 3-4 months, the mechanism behind approved indications including blepharospasm, cervical dystonia, spasticity, chronic migraine, hyperhidrosis, and cosmetic glabellar-line treatment (the latter under brand names Botox, Dysport, Xeomin, Jeuveau, and biosimilars). PeptideXpo distributes Botulinum Toxin Type A only to qualified buyers with explicit import authorization, controlled-substance licensing, and chain-of-custody documentation in their destination jurisdiction. The product is supplied as the lyophilized 150 kDa complex stabilized with human serum albumin, in the standard 100 IU vial format. As a Schedule 1 select-agent in the US and analogous classifications worldwide, orders require full compliance review including end-user declaration, intended-use specification, and storage / handling protocol confirmation prior to acceptance. Material is shipped via controlled-cold-chain logistics with monitoring documentation.
Who buys this, and why
Custom-blend buyers are almost always OEM clients building a branded product around a specific ratio of two or more peptides. The development workflow is collaborative: ratio target, analytical method to verify it, stability protocol in the chosen carrier, and packaging selection are all defined in the OEM brief before the first commercial run. Sample-stage volumes are usually 5-10 g of finished blend; commercial MOQ depends on the components.
Primary buyer fit: regional distributors and re-sellers.
Specifications
Documentation available on request
Regulatory note
Highly regulated neurotoxin classified as a select agent in the US and analogous classifications worldwide. Sold only to qualified buyers with appropriate licensing in their jurisdiction. Order requires full compliance review and import authorization documentation prior to acceptance.
Frequently asked questions
Botulinum Toxin Type A is on the HHS Select Agents and Toxins List in the US (administered by CDC's Federal Select Agent Program) and analogous controlled-biological-agent lists worldwide, because the molecule is acutely toxic at extremely low doses (LD50 in humans estimated at 1-3 ng/kg systemically) and has historical bioweapon potential. Practically, this means buyers must demonstrate (1) a legitimate clinical or research use case, (2) appropriate facility security and storage controls, (3) registered status with their national select-agent regulator, and (4) chain-of-custody documentation throughout the procurement and use lifecycle. PeptideXpo's compliance review for Botulinum Toxin orders includes verification of all four elements before order acceptance.
The bulk active is purified Botulinum Toxin Type A complex, supplied as the lyophilized 150 kDa protein stabilized with human serum albumin. The approved finished products (Botox, Dysport, Xeomin, Jeuveau, Daxxify and biosimilars) are the same active in finished-dose formulations with brand-specific stabilizers, fill volumes, and reconstitution conventions. The clinically-significant differences between brands relate to the accessory proteins surrounding the 150 kDa core toxin (Xeomin is the 'naked' 150 kDa toxin without complex proteins, while Botox includes the full 900 kDa complex), which affects immunogenicity and diffusion characteristics. Bulk material is supplied only to qualified buyers building approved finished products or running registered research programs.
Botulinum Toxin Type A requires strict cold-chain logistics throughout the supply chain: lyophilized bulk active maintains the standard 2-8 °C refrigerated storage requirement, with excursions above 8 °C limited to brief operational handling (loading, unloading) and never exceeding 25 °C. Shipping uses validated cold-chain packaging with continuous temperature monitoring (typically electronic data loggers) throughout transit; the temperature record is part of the released-batch documentation chain. Frozen shipment (-20 °C) is used for long-haul international transit where the 2-8 °C window can't be reliably maintained. Buyers receiving Botulinum Toxin must have validated cold-chain storage in place before delivery; PeptideXpo's logistics team confirms the receiving facility's cold-chain capability as part of the pre-shipment compliance check.
