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Stability of Ketamine Hydrochloride Injection After Reconstitution in Water for Injection and Storage in 1-mL Tuberculin Polypropylene Syringes for Pediatric Use

Author(s):  Gupta Vishnu D

Issue:  Jul/Aug 2002 - Compounding for BHRT and Legal and Regulatory Issues
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Abstract:  The stability of ketamine hydrochloride (10 mg/mL) in water for injection stored in polypropylene syringes has been studied at 25ºC by means of a stability-indicating high-performance liquid chromatographic assay method. The concentrations of the drug were directly related to peak heights, and the percent relative standard deviation based on five injections was 1.9. The drug decomposed only when the solution was boiled after sodium hydroxide was added. It did not decompose in the presence of an acid or after 30 minutes of boiling. The injection did not lose potency after 30 days of storage at 25ºC, and the pH value of 4.2 did not change. Ketamine hydrochloride appears to be a very stable drug.

Related Keywords: Ketamine hydrochloride injection, stability of after reconstitution

Related Categories: PEER-REVIEWED, STABILITIES, COMPATIBILITIES

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