Abstract
Abstract In this study an analytical method for the determination of menthol in aqueous cream was developed, together with the complete validation of the production process and stability testing of 18 months' retained reference samples. Cream packed in 500ml plastic screw cap containers was tested and studied. Up to now there has only been a small scale (1.40kg) manual manufacture of 1%w/w menthol in aqueous cream without any formal quality control analysis and testing carried out on the product. The purpose of this work was to enable large scale manufacture of the product, which would require development of an analytical method and validation of the mixing and filling processes. Stability testing of stored reference samples was carried out concurrently. A stability-indicating, gas-liquid chromatographic method, with the use of an internal standard, was developed and validated for the product. Stability testing of samples stored at 25C ± 1C showed no significant degradation over 18 months. Validation of the manufacturing process by a sequential sampling technique showed the process to be satisfactory and workable at all stages. The current formulation in use is 1%w/w menthol triturated directly into aqueous cream BP.
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