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

This study investigated the chemical stability of pyridoxine hydrochloride injection (100 mg/mL) in sterile water for injection (preservative free) stored at 25 deg 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.