COA Requirements for Compounding Pharmacy Ingredients

Compounding pharmacies operating under USP <797> must document the quality of every ingredient used in sterile preparations. For bacteriostatic water, that means obtaining and retaining a Certificate of Analysis (COA) from your supplier — not a generic product data sheet, but a lot-specific quality document with actual test results.

What a Compliant BAC Water COA Must Include

A COA suitable for USP <797> ingredient documentation must contain the following elements, all referenced to the specific lot number on your order:

• Product identification: “Bacteriostatic Water for Injection” with USP reference
• Lot/batch number: Matching the lot number on your vial label
• Manufacturing date and expiration date
• HPLC benzyl alcohol assay: Specification (0.85%–0.95%) and actual measured result (e.g., 0.91%)
• Endotoxin test (LAL): Limit (<0.25 EU/mL) and actual measured result
• Sterility test: Method (USP <71>) and result (Conforms)
• pH measurement: Range (4.5–7.0) and actual measured value
• Appearance: Clear, colorless, free from visible particulates
• Manufacturer name and contact information

COA Red Flags to Avoid

Be cautious of suppliers whose COA shows only “Pass/Fail” results without measured values, has no lot number traceable to your shipment, lacks endotoxin or HPLC data, or appears generic (not lot-specific). These are signs of inadequate quality documentation that could put your accreditation at risk.

Renew Lab Group COA Guarantee

Every Renew Lab Group order ships with a complete, lot-specific COA containing all required documentation fields with actual measured values. No request needed — it comes standard. View a sample COA here.

Related: USP 797 Compliance Guide | Open a Pharmacy Account | Shop Now