Every lot tested. Every result public.
Every lot of ReconPartner bacteriostatic water is tested per USP <71> Sterility and USP <85> Bacterial Endotoxins. A lot-specific Certificate of Analysis is linked from every product page before you buy.
Our Testing Protocol
USP <71> Sterility
Direct-inoculation sterility testing per USP <71> on 14-day incubation with Fluid Thioglycollate Medium and Soybean-Casein Digest Medium. Every lot must demonstrate no growth to release.
USP <85> Bacterial Endotoxins
Limulus Amebocyte Lysate (LAL) endotoxin testing ensures pyrogen-free release within USP limits. Results appear on every CoA.
Fill Volume Verification
Statistical sampling verifies fill volume is within ±3% of labeled volume across every lot. Short-fill vials are rejected at release.
cGMP Manufacturing
All filtration and filling happens in an FDA-registered, cGMP-compliant US facility under laminar flow in class-100 cleanroom conditions. Full batch records are retained per 21 CFR 211.
What's in Every CoA
Sample Certificate of Analysis
Certificate of Analysis
Bacteriostatic Water 10mL
Lot Number
RP-BAC10-260410
Sterility (USP <71>)
PASS
Endotoxin (USP <85>)
< 0.25 EU/mL
Recent Batch Results
Sample release data from recent bacteriostatic water lots