Microbiological examination of pharmaceutical raw materials | Abstract
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Microbiological examination of pharmaceutical raw materials

Author(s): Rajapandi. Senthilraj, Ganduri Sathyanarayana Prasad and Kunchithapatham Janakiraman

In order to manufacture medicines of acceptable microbiological quality, it is necessary to know the microbial contaminants resulting from raw materials. The microbiological quality of the final product (except manufacturing process) depends only on the quality of the raw materials. Hence it was aimed to assess microbiological quality of fourteen raw materials by conventional methods. Among the chosen samples; Gelatin, Lactose, Sodium alginate and Xanthan gum had higher microbial count and the remaining samples had only few or negligible microbial count in Soyabean-Casein digest broth. Microbial growth was observed in selective media for the samples viz., Thyroxinesodium, Acacia, dried Aluminium hydroxide gel, Gelatin, Lactose, Liquid Paraffin, Sodium alginate, Starch and Xanthan gum. Niacinamide, Magnesium hydroxide, Paracetamol Riboflavin and Tragacanth had not shown any microbial growth on selective media. No selected sample was found to contain any objectionable microorganism. The conventional methods of identification required more than 7 days for completion, so new methods should be followed to avoid wastage of time. The above results indicate that raw materials must be assessed for their microbiological quality, in order to produce quality medicines.