Certificate PL-26-00139 · BAC Water 3 mL · lot PL-2610-017
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PrymaLab
PrymaLab
PrymaLab Analytical · In-house laboratory
3705 Music Branch Rd, Ashland, KY 41102 · +1 (606) 465-9063 · prymalab.net
Certificate no.
PL-26-00139
Verification key
N9SQ8J5Z
Scan or enter both at
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Certificate of Analysis · Lot release

BAC Water 3 mL

Lot PL-2610-017 · Solution · Label claim 3 mL per vial
Tested in-house by PrymaLab
In-house analytical result,
not an independent third-party test
Lot / batch number
PL-2610-017
Date made
2026-10-01
Date of analysis
2026-10-05
Date issued
2026-10-19
Retest / expiry
2028-10-01
Units in lot / sampled
376 / 3
Storage
—
Certificate type
Lot COA, 2 pages
Compound
Bacteriostatic water
Sterile water for injection with benzyl alcohol as preservative; a diluent, not a peptide
CAS number
7732-18-5 (water) · 100-51-6 (benzyl alcohol)
Molecular formula
H2O + benzyl alcohol (C7H8O)
Theoretical mass (avg.)
n/a
Structure
Water for injection preserved with benzyl alcohol
Purity · RP-HPLC, area %
—
Not applicable: bacteriostatic water is a diluent (no HPLC purity test)
Benzyl alcohol · USP <341>
0.92%
Specification 0.85–0.95% • pH 5.8 (specification 4.5–7.0)
Overall conclusion
PASS
Meets every specification for the tests performed
TestMethodSpecificationResultConclusion
Benzyl alcohol contentUSP <341>0.85–0.95%0.92%PASS
pHpH measurement4.5–7.05.8PASS
Bacterial endotoxinLAL, kinetic< 0.5 EU/mL0.09 EU/mLPASS
SterilityUSP <71>, 14-dayNo growthNo growthPASS

1HPLC chromatogram

Data file: — · Column — · UV —
No HPLC test applies to bacteriostatic water.
Not applicable: no HPLC or mass-spectrometry test applies to bacteriostatic water. The tests performed are listed in the table above.
PrymaLab
PrymaLab
Certificate of Analysis · continued
BAC Water 3 mL · Lot PL-2610-017 · Certificate PL-26-00139
Lot PL-2610-017
Method, peak table and approval

2HPLC method · —

Column
—
Detection Wavelength
—
Not applicable
No HPLC test applies to bacteriostatic water

3Gradient program

Time (min)% A% B

4Peak table

PeakRT (min)AreaArea %
Not applicable to bacteriostatic water · Purity = main peak area ÷ total integrated area × 100, to two decimals; main peak shaded.

5Identity by mass spectrometry

Not applicable
No mass-spectrometry test applies to bacteriostatic water

6Additional tests

TestPerformed byDateReport / file
Benzyl alcohol contentPrymaLab Analytical2026-10-05—
pHPrymaLab Analytical2026-10-05—
Bacterial endotoxinPrymaLab Analytical2026-10-05—
SterilityPrymaLab Analytical2026-10-19—
A test with no row here was not performed on this lot. Outside-laboratory reports, when used, are attached and named below.

7Review and approval

D. Reynolds
Analyst · performed the testing
Date: 2026-10-19
S. Calloway
Reviewer · checked against raw data
Date: 2026-10-19
M. Phelps
Lab Director · approved for release
Date: 2026-10-19