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Xechem Nigeria Ltd.

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R & D

Xechem & Nigeria

Microbiology
The Microbiology laboratory is headed by Dr. Swami Nathan who leads a team of well trained microbiologist and technicians with experience in quality control testing of raw material, water, in-process and finished product and packaging material (caps and bottles). Evaluation of manufacturing water is carried out on weekly basis and the results are reported to the Production Department.The Microbial tests are carried out as per the microbial limit test (as per USP 26, 2021, part 61) and absence/presence pathogens like Salmonella, Pseudomonas, E. coli and Staphylococcusaureus is ascertained. Total bacterial count and yeast molds count are alsoincluded in the evaluation.The reference microbial cultures are sub-cultured fortnightly and the purity of the cultures is maintained by microscopic examination and gram staining. The laboratory is equipped with an industrial 8 ft bio-hood, autoclave, incubator, pH meter, stirrer, hot plate, analytical balances, refrigerator, other minor equipments and culture media.All the tests and experiments are conducted following the guidelines for current Good Laboratory Practices (cGLP). To evaluate the efficacy of the NICOSAN™ extract, to be used for production of capsules, a bioassay based on sickle erythrocytes is conducted on extract of each lot or batch..

Chemistry
The major activities of QC –chemistry laboratory are testing of raw materials used in the production of NICOSAN™ and testing in-process material and finished product of NICOSAN™. Raw material testing includes thin Layer Chromatography (TLC) of plant extract, pH measurement and moisture content determination. In process material like NICOSAN™ extract, spray dried powder, formulation and capsules are tested, using High Performance Liquid Chromatography (HPLC), for the presence of active ingredients of the plant materials used. Shelf life of active pharmaceutical ingredient (API) and finished product is evaluated on monthly basis. To carry out all the above tests and analyses the laboratory is equipped with standard equipments like pH meter, TLC apparatus, HPLC system, microscope, rotary evaporator, magnetic stirrers, hot plates, and reagents and chemicals of high purity. All the experiments and tests are conducted keeping in view the guidelines for current Good Laboratory Practices (cGLP)