Extended Stability of Sodium Bicarbonate Infusions Prepared in Polyolefin Bags

• Published in: Hospital pharmacy (Philadelphia) 2012-07, Vol.47 (7), p.538-543
• Main Authors: Sayre, Brian E., Prettyman, Terrence, Kaushal, Gagan
• Format: Article
• Language: English
• ISSN: 0018-5787; 1945-1253
• DOI: 10.1310/hpj4707-538

Purpose To investigate the stability of 0.1 mEq/mL and 0.15 mEq/mL strengths of extemporaneously compounded sodium bicarbonate preparations. Methods Sterile preparations of sodium bicarbonate of 2 strengths (0.1 mEq/mL and 0.15 mEq/mL) were compounded in accordance with USP standards. To carry out the stability testing, these products were stored under 3 temperature conditions: −20°C, 2°C-8°C, and 23°C-25°C. Under the stability studies, pH, particulate matter, and the active content were monitored for 30 days. Results Sodium bicarbonate infusions are stable for 21 days when stored at −20°C or 2°C −8°C and are stable for 7 days when stored at room temperature (23°C-25°C). These data demonstrate that sodium bicarbonate infusions have extended physical and chemical stability after preparation. Conclusions The stability analysis results show that the observed shelf life was far better than the recommended expiration dates. This will allow the hospitals to give longer dating to sodium bicarbonate preparations, provided they are prepared in a sterile environment and are in compliance with USP guidelines.