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I am developing a Fixed Dose Combination dosage form, which have an active pharmaceutical ingredient in the coat and another one in an extended release core of tablet. During development, I have...
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Vial integrity test is crucial for parenteral solution in the aspect of stability on shelf, and sterility. In vacuum decay test, the samples float in a colorful solution. When pressure reduces by...
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Hi, The formula of DAR measurement based on Beer - Lambert law has been presented by Chen Y under the title of Drug-to-antibody ratio (DAR) by UV/Vis spectroscopy. Based on Beer- Lambert Law...
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We often have molecules like Methotrexate which has two carboxylic groups. These two similar substitution have different pKa. So, the ionization pH of each one is different. Also, they are weak...
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How should visual inspection be done for parenteral solution with dark blue color in transparent vial? We are manufacturing a new parenteral product which has dark blue color and is filling in...
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Unstable drug in aqueous solution is drying by lyophilization process to produce dry cake which makes solution after reconstitution by suitable diluent before administration for patients. In drug...
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