Bacteriostatic water (BAC water)- (for injection (bWFI))- is a common diluent for parenteral
pharmaceutical products. bWFI is sterile water for injection containing one or more suitable
antimicrobial agents to suppress the growth of microbial contaminants. United States Pharmacopeia
(USP) monograph describes bWFI with pH ranging from pH 4.5 to 7.0. Lacking buffering reagents, bWFI
has very low ionic strength, no buffering capacity and is prone to sample contamination. These
characteristics pose a challenge for accurate bWFI pH measurements which are characterized by long
response times and noisy signals, resulting in inconsistent results. The challenging nature of bWFI pH
measurement, however, is not fully recognized as pH is generally considered a routine analytical
technique. Even with the addition of KCl to increase ionic strength as recommended by the USP bWFI
monograph, variability in pH results is still observed without careful consideration of other critical
measurement factors. To bring awareness to the challenges associated with bWFI pH measurement, we
present a comprehensive characterization of the bWFI pH measurement process that includes an
evaluation of probe suitability, measurement stabilization time, and pH meter settings. While these
factors may be non-critical and sometimes overlooked when developing pH methods for buffered
samples, they can have a significant impact on bWFI pH measurement. We present recommendations
that can help reliable bWFI pH measurements for routine execution in a controlled environment. These
recommendations also apply to other pharmaceutical solutions or water samples with low ionic
strength.
Reference:
Hu J, Kyad A, Burke K, Sakiyama L, Moraes De Souza C, Pope S, Blue L, Cohen D, Semin D, Goudar C.
Critical Aspects of pH Measurement for Bacteriostatic Water for Injection. J Pharm Sci. 2023
Aug;112(8):2307-2310. doi: 10.1016/j.xphs.2023.02.023. Epub 2023 Mar 3. PMID: 36870668.
Bacteriostatic Water
$5.00 – $25.00
Bacteriostatic water (BAC water)- (for injection (bWFI))- is a common diluent for parenteral
pharmaceutical products. bWFI is sterile water for injection containing one or more suitable
antimicrobial agents to suppress the growth of microbial contaminants. United States Pharmacopeia
(USP) monograph describes bWFI with pH ranging from pH 4.5 to 7.0. Lacking buffering reagents, bWFI
has very low ionic strength, no buffering capacity and is prone to sample contamination.
| Weight | .5 oz |
|---|---|
| Size | 10ML, 2ML, 30ML |
47 reviews for Bacteriostatic Water
| 5 star | 97% | |
| 4 star | 2% | |
| 3 star | 0% | |
| 2 star | 0% | |
| 1 star | 0% |
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AR is the only place I purchase Bac water from. It’s consistent and shipping is quick.
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