Preclinical Laboratory needed for comparison, pilot and pharmacokinetic studies on a single active pharmaceutical ingredient from different brands. A pilot study on different brands of a particular active
1.Quality control checks on the products: weight variation, friability, content uniformity, hardness, disintegration test, dissolution test, identification test, thickness &hardness, and Assay
2. Determination, isolation, characterization and quantitation of different impurities potentially present.
3. Possible Forced degradation studies to determine and changes in drug qualities with a repeat of the above tests. * Impact of temperature, light, oxygen, water etc
4. Pharmacokinetic studies in SIF and SGF of samples as well as forced degraded samples.
Other Pharmaceuticals testing, analysis, scientific research and development, inspection, certification, engineering, failure investigation, and product development needs include :
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