Every vial, every lot, every time.
Formulated and tested to meet USP-grade standards. Here's how documented processes and QC support each production run.
Full transparency, every batch.
Every production lot ships with a complete Certificate of Analysis. No exceptions, no delays, no "available upon request" runaround. The COA is part of the shipment.
Each COA documents sterility testing results, endotoxin levels (LAL test), pH measurement, benzyl alcohol concentration verification, and container closure integrity. Testing is performed by accredited third-party laboratories.
Need to review a COA before placing an order? We'll send one from a recent production lot so your QA team can evaluate before committing.
What's on every COA
USP CHAPTER
797
Scope
Compounding of sterile preparations
Authority
United States Pharmacopeia
Requirements
Environmental controls, personnel training, process validation, quality assurance protocols
The sterile compounding standard.
USP Chapter 797 is the United States Pharmacopeia's standard for sterile preparation and compounding. It defines the minimum practices and quality standards for preparing compounded sterile preparations (CSPs).
Our manufacturing processes follow documented SOPs and QC controls aligned with USP 797 requirements, including controlled cleanroom conditions, validated sterilization processes, in-process quality controls, and end-product testing.
For wholesale buyers, this alignment provides a documented quality framework from controlled manufacturing through end-product testing.
Formulated and tested to meet USP-grade standards.
Formulated and tested to meet USP-grade standards. The 0.9% benzyl alcohol formulation is produced under current Good Manufacturing Practice (cGMP) guidelines and documented SOPs and QC controls.
cGMP controls cover facility maintenance, documented equipment calibration and preventive maintenance, raw material sourcing and testing, production processes, packaging and labeling accuracy, and record-keeping for traceability.
Every lot is independently tested for sterility, endotoxin, pH, and preservative concentration, then released with a full Certificate of Analysis so quality results can be verified before it ships.
cGMP covers
We don't grade our own homework.
Every production batch is sent to independent third-party laboratories for testing. These results supplement documented in-process QC controls.
Sterility Testing
Per USP <71>, samples are incubated in both fluid thioglycollate medium and soybean-casein digest medium for 14 days. Any microbial growth means the lot is rejected.
Endotoxin Analysis
Limulus Amebocyte Lysate (LAL) testing per USP <85>. Endotoxin levels must fall below established thresholds. Results are quantified and documented on the COA.
pH & Preservative
Each lot is checked for pH and benzyl alcohol concentration against its documented specifications.
From raw material to your receiving dock.
Every vial carries a lot number that traces back through the entire production chain. If you ever have a question about a specific unit, we can tell you exactly where it came from.
Raw Material Intake
Sourced, tested, logged
Compounding
Batch mixed, QC sampled
Fill & Seal
Aseptic fill, crimp sealed
Testing & Release
Third-party lab verified
Ship & Deliver
Lot-linked to your PO
Clean rooms, not cutting corners.
Production takes place in ISO-classified cleanroom environments with HEPA filtration.
Production and quality-control activities follow documented SOPs, with in-process checks and lot records supporting consistent execution and traceability.
Equipment is calibrated on documented schedules and maintained under a preventive maintenance program. Water systems use USP purified water with routine monitoring for bioburden and conductivity.
ISO-Classified Cleanrooms
Controlled environments with HEPA filtration
Documented Process Controls
Production SOPs, in-process QC checks, and traceable lot records
Equipment Maintenance
Documented calibration schedules and preventive maintenance programs
Water System QC
USP purified water with routine bioburden and conductivity monitoring
Ready to see the documentation firsthand?
Request the current shipping lot's COA or get wholesale pricing. Our team typically responds within one business day.
