Chemical Stability of Pyridoxine Hydrochloride 100-mg/mL Injection, Preservative Free

Gupta, Vishnu D

Abstract

Chemical Stability of Pyridoxine Hydrochloride 100-mg/mL Injection, Preservative Free

Author(s): Gupta Vishnu D

Issue: Jul/Aug 2006 - Sterile Preparations

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Page(s): 318-319

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Abstract

This study investigated the chemical stability of pyridoxine hydrochloride injection (100 mg/mL) in sterile water for injection (preservative free) stored at 25°C in disposable polypropylene syringes of various sizes. The United States Pharmacopeia– National Formulary colorimetric assay method was used. The method is accurate and precise, with a percent relative standard deviation of 1.0 based on five readings. The injection was stable for at least 180 days (no decomposition). The pH value of the injection remained constant at 2.4, and the physical appearance of the injection remained clear throughout the study period. The sterility of the injection at various intervals was not determined.

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