Certificate of Analysis
BAC Water3mL / vial · Full QC Panel
Report number
ASC-2024-0821-010
Certified
August 28, 2024
Access code
9VR2Z2Q8
Scan to verify
Identity
PASS
Sterility
PASS
Endotoxin
PASS
Heavy metals
PASS
Sample
Client / brand
Ascend Research
Product
BAC Water
Batch number
AR-BAC-3-2408
Product form
Solution in vial
Labeled quantity
3mL / vial
Fill volume
3mL
Declared CompositionComposition per USP Bacteriostatic Water for Injection: water preserved with 0.9% w/v benzyl alcohol. Preservative content as declared by the submitting party.
Benzyl alcohol 27 mg · 100-51-6 · C7H8O
Water for Injection balance · 7732-18-5 · H2O
Test Results
| Analyte | Specification | Result | Unit | Status |
|---|---|---|---|---|
| Identity (HPLC-RT) | Matches reference standard | Confirmed | — | PASS |
| Heavy Metals (ICP-MS) | As, Cd, Pb, Hg, Cr within limits | See detail | ppm | PASS |
| Sterility (PCR) | No growth detected | No Growth | — | PASS |
| Endotoxin (kinetic chromogenic) | < 0.25 EU/mL | 0.04 | EU/mL | PASS |
Analytical Method
Method RP-HPLC (USP <621>)
Column C18, 4.6 x 150 mm, 3.5 um
Mobile phase A: 0.1% TFA in water / B: 0.1% TFA in acetonitrile
Gradient 5-65% B over 20 min
Detection UV 214 nm
Flow rate 1.0 mL/min
Injection 10 uL
Retention time Not applicable
Notes & Methodology
- Identity confirmed by comparison of chromatographic retention time against a characterized reference standard.
- Elemental impurities analyzed by ICP-MS following USP <233> methodology. Acceptance criteria are internal laboratory screening limits for research-use materials and do not represent evaluation against any pharmacopeial monograph or product specification.
- Sterility screening performed by PCR (polymerase chain reaction). This is a nucleic-acid detection method and is not equivalent to a compendial sterility test.
- Bacterial endotoxin determined by USP <85> kinetic chromogenic method.
- This certificate reports analytical results for the sample(s) submitted to United Diagnostics for testing. Sample identification, product name, brand, lot number and labeled content are provided by the submitting party and have not been independently verified. Results reflect only the analytical testing of the specific sample(s) provided and do not constitute an evaluation or endorsement of the manufacturer's processes, quality systems, or overall production.
- United Diagnostics makes no representations regarding the intended use, safety, efficacy, regulatory status, or intellectual property ownership of any material tested. Materials tested are for research use only and are not for human or veterinary use, and not for diagnostic or therapeutic use.
Analyzed by
Alisa Morovitz
Analytical Chemist
Analysis completed 08/27/2024
Reviewed & authorized by
Evan Atkinson
Principal Chemist
Authorized 08/28/2024