Quality & Documents

Every lot, every test, on the record.

A bacteriostatic water COA that only says “passes” tells you little. Ours lists each release test with its method and limit, and ties the result to the lot number on your vial.

How we show a COA

Lot data in the open

Product, size, lot, manufacture and expiry dates and every test result are published as text on the product page.

Original file on request

The certificate itself is shown as a locked preview; the PDF is e-mailed with your quote or order.

Same lot on the label

The lot number on the COA is the lot printed on the vial and on the carton packing list.

Lot records shown below are examples of the format: real lot data replaces them as lots are released.

Release specifications

Bacteriostatic Water — 3 mL, 5 mL, 10 mL, 30 mL

Test	Method	Acceptance criterion
Appearance	Visual examination against the stated description	Clear, colorless solution
Water and benzyl-alcohol component identity	Qualified water-grade document review plus GC retention-time and FTIR comparison against a qualified benzyl-alcohol reference	Water grade conforms to the released specification and the preservative is identified as benzyl alcohol; component identity does not by itself establish concentration, sterility or finished-product status
Benzyl alcohol content	GC-FID with a qualified external reference and validated v/v calculation	0.9% ± 0.1% (v/v)
pH	Potentiometry (USP <791>)	5.0–7.0
Elemental impurities	ICP-MS (USP <233>), closed-vessel microwave digestion	Cd NMT 0.2; Pb 0.5; As 1.0; Hg 0.3; Co 0.5; V 1.0; Ni 2.0; Li 5.0; Sb 1.0; Cu 5.0 ppm; sum of Cd, Pb, As, Hg, Co, V and Ni <4.0 ppm
Antimicrobial effectiveness	USP <51>, Category 1 challenge with five specified organisms through 28 days	Meets USP <51> Category 1 criteria for the tested released formulation; this result does not sterilize a contaminated vial or replace aseptic controls
Fill volume	Gravimetric determination with validated density correction	BACW-03ML: 3.00 mL/vial ±3.0%; BACW-05ML: 5.00 mL/vial ±3.0%; BACW-10ML: 10.00 mL/vial ±3.0%; BACW-30ML: 30.00 mL/vial ±3.0%
Particulate matter	Light obscuration (USP <788> Method 1); visible particles per USP <790>	NMT 6000 particles ≥10 µm and NMT 600 particles ≥25 µm per container; essentially free from visible particulates
Bacterial endotoxins	Kinetic chromogenic LAL (USP <85>)	NMT 0.25 EU/mL
Sterility	USP <71>, membrane filtration with demonstrated method suitability	Sterile — no growth

Sterile Water — 3 mL, 10 mL

Test	Method	Acceptance criterion
Appearance	Visual examination against the stated description	Clear, colorless solution
Identification	FTIR	Infrared absorption spectrum concordant with that of the reference standard
Conductivity / Total organic carbon	USP <645> conductivity; USP <643> TOC	Conductivity NMT 1.3 µS/cm at 25 °C; TOC NMT 500 ppb
pH	Potentiometry (USP <791>)	5.0 – 7.0
Elemental Impurities (ICH Q3D / USP <232>, <233>)	ICP-MS (USP <233>), closed-vessel microwave digestion	Cd NMT 0.2; Pb NMT 0.5; As NMT 1.0; Hg NMT 0.3; Co NMT 0.5; V NMT 1.0; Ni NMT 2.0; Li NMT 5.0; Sb NMT 1.0 ppm (ICH Q3D, parenteral); Cu NMT 5.0 ppm. Additional house requirement: Σ of Class 1 + Class 2A (Cd, Pb, As, Hg, Co, V, Ni) < 4.0 ppm
Fill volume (gravimetric)	Gravimetric, density-corrected	3.00 mL/vial ± 5.0%
Particulate matter	Light obscuration (USP <788> Method 1); visible: USP <790>	NMT 6000 particles ≥10 µm and NMT 600 ≥25 µm per container; essentially free from visible particulates
Bacterial Endotoxins	Kinetic chromogenic LAL (USP <85>)	NMT 0.25 EU/mL (USP <85>)
Sterility	USP <71>, membrane filtration; method suitability performed	Sterile — no growth (USP <71>)
Fill volume (gravimetric)	Gravimetric, density-corrected	10.00 mL/vial ± 5.0%

0.6% Acetic Acid Water — 3 mL, 5 mL, 10 mL

Test	Method	Acceptance criterion
Appearance	Visual examination against the stated description	Clear, colorless solution
Acetic acid identity	FTIR compared with a qualified acetic-acid reference standard	Infrared absorption spectrum concordant with that of the reference standard
Acetic acid content	Titration with 0.1 N NaOH, potentiometric endpoint (USP <541>)	0.57%–0.63% (v/v)
pH	Potentiometry (USP <791>)	2.7–3.1
Elemental impurities	ICP-MS (USP <233>), closed-vessel microwave digestion	Cd NMT 0.2; Pb NMT 0.5; As NMT 1.0; Hg NMT 0.3; Co NMT 0.5; V NMT 1.0; Ni NMT 2.0; Li NMT 5.0; Sb NMT 1.0; Cu NMT 5.0 ppm; sum of Cd, Pb, As, Hg, Co, V and Ni <4.0 ppm
Fill volume	Gravimetric, density-corrected	AAW-03ML: 3.00 mL/vial ±5.0%; AAW-05ML: 5.00 mL/vial ±5.0%; AAW-10ML: 10.00 mL/vial ±5.0%
Particulate matter	Light obscuration (USP <788> Method 1); visible particles: USP <790>	NMT 6000 particles ≥10 µm and NMT 600 particles ≥25 µm per container; essentially free from visible particulates
Bacterial endotoxins	Kinetic chromogenic LAL (USP <85>)	NMT 0.25 EU/mL
Sterility	USP <71>, membrane filtration; method suitability performed	Sterile — no growth

Lot records (examples)

Original file on request

Example data · not a real lot

Bacteriostatic Water 10 mL

Lot: EXAMPLE-BW10-2608
Manufactured: 2026-08
Expiry: 2028-08
Container: Clear glass vial · grey butyl rubber stopper · aluminium flip-off seal

Test	Method	Specification	Result
Appearance	Visual examination against the stated description	Clear, colorless solution	Conforms (example)
Water and benzyl-alcohol component identity	Qualified water-grade document review plus GC retention-time and FTIR comparison against a qualified benzyl-alcohol reference	Water grade conforms to the released specification and the preservative is identified as benzyl alcohol; component identity does not by itself establish concentration, sterility or finished-product status	Conforms (example)
Benzyl alcohol content	GC-FID with a qualified external reference and validated v/v calculation	0.9% ± 0.1% (v/v)	0.91% v/v (example)
pH	Potentiometry (USP <791>)	5.0–7.0	5.8 (example)
Elemental impurities	ICP-MS (USP <233>), closed-vessel microwave digestion	Cd NMT 0.2; Pb 0.5; As 1.0; Hg 0.3; Co 0.5; V 1.0; Ni 2.0; Li 5.0; Sb 1.0; Cu 5.0 ppm; sum of Cd, Pb, As, Hg, Co, V and Ni <4.0 ppm	All elements below limits (example)
Antimicrobial effectiveness	USP <51>, Category 1 challenge with five specified organisms through 28 days	Meets USP <51> Category 1 criteria for the tested released formulation; this result does not sterilize a contaminated vial or replace aseptic controls	Meets Category 1 criteria (example)
Fill volume	Gravimetric determination with validated density correction	10.00 mL/vial ±3.0%	10.08 mL (example)
Particulate matter	Light obscuration (USP <788> Method 1); visible particles per USP <790>	NMT 6000 particles ≥10 µm and NMT 600 particles ≥25 µm per container; essentially free from visible particulates	≥10 µm: 120 / container; ≥25 µm: 8 / container (example)
Bacterial endotoxins	Kinetic chromogenic LAL (USP <85>)	NMT 0.25 EU/mL	< 0.10 EU/mL (example)
Sterility	USP <71>, membrane filtration with demonstrated method suitability	Sterile — no growth	No growth (14 days) (example)

The full certificate (PDF) for your lot is sent by our sales team. Request this lot's COA

Original file on request

Example data · not a real lot

Bacteriostatic Water 30 mL

Lot: EXAMPLE-BW30-2608
Manufactured: 2026-08
Expiry: 2028-08
Container: Clear glass vial · grey butyl rubber stopper · aluminium flip-off seal

Test	Method	Specification	Result
Appearance	Visual examination against the stated description	Clear, colorless solution	Conforms (example)
Water and benzyl-alcohol component identity	Qualified water-grade document review plus GC retention-time and FTIR comparison against a qualified benzyl-alcohol reference	Water grade conforms to the released specification and the preservative is identified as benzyl alcohol; component identity does not by itself establish concentration, sterility or finished-product status	Conforms (example)
Benzyl alcohol content	GC-FID with a qualified external reference and validated v/v calculation	0.9% ± 0.1% (v/v)	0.91% v/v (example)
pH	Potentiometry (USP <791>)	5.0–7.0	5.8 (example)
Elemental impurities	ICP-MS (USP <233>), closed-vessel microwave digestion	Cd NMT 0.2; Pb 0.5; As 1.0; Hg 0.3; Co 0.5; V 1.0; Ni 2.0; Li 5.0; Sb 1.0; Cu 5.0 ppm; sum of Cd, Pb, As, Hg, Co, V and Ni <4.0 ppm	All elements below limits (example)
Antimicrobial effectiveness	USP <51>, Category 1 challenge with five specified organisms through 28 days	Meets USP <51> Category 1 criteria for the tested released formulation; this result does not sterilize a contaminated vial or replace aseptic controls	Meets Category 1 criteria (example)
Fill volume	Gravimetric determination with validated density correction	30.00 mL/vial ±3.0%	30.24 mL (example)
Particulate matter	Light obscuration (USP <788> Method 1); visible particles per USP <790>	NMT 6000 particles ≥10 µm and NMT 600 particles ≥25 µm per container; essentially free from visible particulates	≥10 µm: 120 / container; ≥25 µm: 8 / container (example)
Bacterial endotoxins	Kinetic chromogenic LAL (USP <85>)	NMT 0.25 EU/mL	< 0.10 EU/mL (example)
Sterility	USP <71>, membrane filtration with demonstrated method suitability	Sterile — no growth	No growth (14 days) (example)

The full certificate (PDF) for your lot is sent by our sales team. Request this lot's COA

Original file on request

Example data · not a real lot

Sterile Water 10 mL

Lot: EXAMPLE-SW10-2608
Manufactured: 2026-08
Expiry: 2028-08
Container: Clear glass vial · grey butyl rubber stopper · aluminium flip-off seal

Test	Method	Specification	Result
Appearance	Visual examination against the stated description	Clear, colorless solution	Conforms (example)
Identification	FTIR	Infrared absorption spectrum concordant with that of the reference standard	Conforms (example)
Conductivity / Total organic carbon	USP <645> conductivity; USP <643> TOC	Conductivity NMT 1.3 µS/cm at 25 °C; TOC NMT 500 ppb	0.8 µS/cm; TOC 120 ppb (example)
pH	Potentiometry (USP <791>)	5.0 – 7.0	6.0 (example)
Elemental Impurities (ICH Q3D / USP <232>, <233>)	ICP-MS (USP <233>), closed-vessel microwave digestion	Cd NMT 0.2; Pb NMT 0.5; As NMT 1.0; Hg NMT 0.3; Co NMT 0.5; V NMT 1.0; Ni NMT 2.0; Li NMT 5.0; Sb NMT 1.0 ppm (ICH Q3D, parenteral); Cu NMT 5.0 ppm. Additional house requirement: Σ of Class 1 + Class 2A (Cd, Pb, As, Hg, Co, V, Ni) < 4.0 ppm	All elements below limits (example)
Particulate matter	Light obscuration (USP <788> Method 1); visible: USP <790>	NMT 6000 particles ≥10 µm and NMT 600 ≥25 µm per container; essentially free from visible particulates	≥10 µm: 120 / container; ≥25 µm: 8 / container (example)
Bacterial Endotoxins	Kinetic chromogenic LAL (USP <85>)	NMT 0.25 EU/mL (USP <85>)	< 0.10 EU/mL (example)
Sterility	USP <71>, membrane filtration; method suitability performed	Sterile — no growth (USP <71>)	No growth (14 days) (example)
Fill volume (gravimetric)	Gravimetric, density-corrected	10.00 mL/vial ± 5.0%	10.08 mL (example)

The full certificate (PDF) for your lot is sent by our sales team. Request this lot's COA

Original file on request

Example data · not a real lot

0.6% Acetic Acid Water 10 mL

Lot: EXAMPLE-AA10-2608
Manufactured: 2026-08
Expiry: 2028-08
Container: Clear glass vial · grey butyl rubber stopper · aluminium flip-off seal

Test	Method	Specification	Result
Appearance	Visual examination against the stated description	Clear, colorless solution	Conforms (example)
Acetic acid identity	FTIR compared with a qualified acetic-acid reference standard	Infrared absorption spectrum concordant with that of the reference standard	Conforms (example)
Acetic acid content	Titration with 0.1 N NaOH, potentiometric endpoint (USP <541>)	0.57%–0.63% (v/v)	0.60% v/v (example)
pH	Potentiometry (USP <791>)	2.7–3.1	2.9 (example)
Elemental impurities	ICP-MS (USP <233>), closed-vessel microwave digestion	Cd NMT 0.2; Pb NMT 0.5; As NMT 1.0; Hg NMT 0.3; Co NMT 0.5; V NMT 1.0; Ni NMT 2.0; Li NMT 5.0; Sb NMT 1.0; Cu NMT 5.0 ppm; sum of Cd, Pb, As, Hg, Co, V and Ni <4.0 ppm	All elements below limits (example)
Fill volume	Gravimetric, density-corrected	10.00 mL/vial ±5.0%	10.08 mL (example)
Particulate matter	Light obscuration (USP <788> Method 1); visible particles: USP <790>	NMT 6000 particles ≥10 µm and NMT 600 particles ≥25 µm per container; essentially free from visible particulates	≥10 µm: 120 / container; ≥25 µm: 8 / container (example)
Bacterial endotoxins	Kinetic chromogenic LAL (USP <85>)	NMT 0.25 EU/mL	< 0.10 EU/mL (example)
Sterility	USP <71>, membrane filtration; method suitability performed	Sterile — no growth	No growth (14 days) (example)

The full certificate (PDF) for your lot is sent by our sales team. Request this lot's COA

Every size has its own record on its product page. How to read a water COA →

Documents you can request

Lot COA (PDF) — with each quote and shipment
Specification sheet per product
Safety data sheet (SDS)
Packing list with lot numbers per carton

What we do not claim

We publish the tests our product is released against. We do not label it with pharmacopoeia grades, registrations or certifications that a lot's documents do not show.