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 →
Preservative-free sterile water reconstitution diluent
Vialdyne primary owner
This Vialdyne page is the primary SEO owner for buyers evaluating Sterile Water for Injection through a pharmacy QA, clinic procurement, or regulated-sourcing workflow. It should answer whether the buyer can request a batch COA, release-test scope, destination-market review, and add-on documentation before moving into pricing or repeat inventory planning.
Overview
Sterile Water for Injection, catalogued as SWFI, is the unpreserved single-use reconstitution medium for peptides and related sterile injectable preparations. The total absence of any antimicrobial agent is what differentiates SWFI from Bacteriostatic Water, and it makes SWFI the right diluent for two distinct use cases. The first is any preparation that will be used as single-use within a short window post-reconstitution, where multi-use preservation simply is not needed and the preservative would only add unnecessary chemistry to the system. The second is any peptide where benzyl alcohol or other preservatives are chemically incompatible with the peptide or with the downstream application. SWFI is additionally the recommended diluent for sterile-filled finished products whose preservation system is built into the formulation itself rather than the diluent. Vialdyne releases SWFI in 3 ml and 10 ml sterile vial presentations. The release packet documents sterility, LAL endotoxin per USP <85>, and pH against the appropriate pharmacopoeia monograph for the destination market. The selection logic for receiving pharmacies reduces to a three-way branch: peptides that need acidic pH route to the 0.6% Acetic Acid Water option; peptides where preservatives are chemically problematic route to SWFI under single-use prep; preservative-compatible peptides intended for multi-use dispensing route to BAC Water. The correct selection per SKU is documented on the relevant product page and on the released-batch COA.
Applications & buyer fit
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.
Sourced for
Buyer fit
Documentation that ships
Procurement note: Ratio target, the analytical method to verify it, stability protocol, and packaging are defined in the OEM brief before the first commercial run.
Primary buyer fit: 503A / 503B compounding pharmacies, academic and contract research laboratories, and regional distributors and re-sellers.
Specifications
Regulatory note
For single-use preparations, this reconstitution diluent is preservative-free. Confirm sterility, pyrogen (LAL), and injectable-grade compliance against your target market's regulations.
Frequently asked questions
For an injectable-grade water the meaningful controls are conductivity, total organic carbon, bacterial endotoxin, and microbial limits, alongside sterility and container-closure integrity for the filled vial. The certificate should tie a named lot to those results, state the fill volume, and reference the Water for Injection monograph the batch was released against. For pharmacies operating into multiple regions, confirm which pharmacopeial equivalent the documentation supports before you standardize on it. Because there is no preservative, your qualification file should also record the labeled in-use window so the short post-puncture life is captured in your standard operating procedure.
The absence of a bacteriostatic agent shifts the whole handling model toward single-use or a very short refrigerated window, because nothing suppresses organisms introduced at septum entry. Practically, plan preparations around immediate use, treat each pierced vial as effectively single-patient, and avoid pooling doses across days. Where a preparation genuinely needs multi-dose economy and the compound tolerates it, a preserved diluent is the operational alternative; where the compound is preservative-incompatible, accept the short window as the cost of compatibility. Document the discard time on the container so staff do not extend it by habit.
Related peptides
