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Article Title

The stability study of meperidine hydrochloride injection from different ampules

Abstract

Meperidine hydrochloride is used extensively as an analgesic agent. Although it is generally stable, it is not uncommon that the hydrolysis to meperidinic acid rendered this ester drug to a decrease in pH value. Therefore the stability of Meperidine HCl injection is of pharmaceutical concen. The objet of the present research is to assess the decomposition of Meperidine HCl in sealed injection packaged in colorless or in amber ampules. Accelerated tests as well as storage tests were executed at 40°C, 60°C and 80°C for both ampule types. No differences in transparency, pH change or quanty of meperidine were observed either in accelerated tests at 40°C or storage test for six months. Nevertheless, a decrease in pH value without significant changes of transparency and meperidine content was observed in accelerated tests at 60°C after storage for 15 weeks. The pH value and meperidine content decrease significantly in both types of ampules when subjected to accelerated tests at 80°C for 15 weeks. Since the decreases of meperidine content were found to be similar for both types of ampules, the stability of meperidine is not correlated with ampule type.

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