Analytical Data

Technical
Data Sheet

Batch average values independently verified to USP and Ph. Eur. standards. Each lot is manufactured under full aseptic processing in an ISO Class 5 cleanroom environment.

BAC WATER AU · 10ml Bacteriostatic Water for Injection

Active preservative Benzyl alcohol 0.9% w/v
pH (25°C) 5.7  (range 4.5–7.0)
Osmolality 9 mOsm/kg
Endotoxin limit < 0.25 EU/ml
Sterility test Meets USP <71>
Preservative effectiveness USP <51> / Ph. Eur. 5.1.3
Volume 10 ml
Container Type I borosilicate glass vial
Closure Bromobutyl rubber stopper
Sterile filtration 0.22 µm membrane
In-use period (opened) 28 days at 2–8°C
Shelf life (sealed) 24 months
ISO

Class 5 cleanroom

0.22

µm sterile filtration

28d

in-use stability

USP

pharmacopoeial grade

Storage

Storage conditions

Store below 25°C, protected from light. Do not freeze. Sealed vials carry a 24-month shelf life from the date of manufacture.

Once penetrated, store at 2–8°C between withdrawals. Use within 28 days of first opening. Discard any unused portion after this period.

Handling

Use instructions

Inspect visually before each use. Discard if particulate matter or discolouration is observed. Use a single-use needle for each withdrawal to maintain sterile integrity.

Not indicated for use with neonates. For research and clinical use only in accordance with applicable regulations.

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