Pharmaceutical-Grade BAC Water | Houston, TX | HPLC-Tested | COA Every Order
What Is Beyond-Use Dating (BUD)?
BUD vs Expiration Date — Key Difference
An expiration date is assigned by a commercial drug manufacturer based on stability studies conducted over months or years. A beyond-use date is assigned by a compounding pharmacy based on USP <797> guidance, available stability data, and the specific preparation’s storage conditions. BUDs are typically much shorter than commercial expiration dates.
USP 797 BUD Categories for Sterile Preparations
| Category | Room Temp (≤25°C) | Refrigerated (2–8°C) | Frozen |
|---|---|---|---|
| Category 1 (low contamination risk) | 12 hours | 24 hours | N/A |
| Category 2 (with extended BUD data) | Up to 30 days | Up to 90 days | Up to 180 days |
How Bacteriostatic Water Affects BUD
When bacteriostatic water is used as the reconstitution vehicle for a compounded sterile preparation, the 0.9% benzyl alcohol preservative contributes to a longer acceptable BUD compared to preparations made with plain sterile water. The preservative inhibits microbial growth in multi-use preparations, allowing for extended use periods within USP <797> parameters.
For compounding pharmacies purchasing bacteriostatic water as an ingredient, Renew Lab Group provides lot-specific COA documentation — including HPLC benzyl alcohol assay results, endotoxin data, and sterility confirmation — required for BUD documentation compliance.
Documentation Requirements
Compounding pharmacies must document the source and quality of all compounding ingredients. For bacteriostatic water, this includes: supplier COA with HPLC assay, endotoxin testing results, lot number and expiration date. Renew Lab Group provides all required documentation with every order. See our bulk ordering page for pharmacy accounts and our COA guide for documentation details.
Related: USP Manufacturing Standards | Compounding Pharmacies Guide | Contact for Wholesale
