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DRUG-EXCIPIENT COMPATIBILITY STUDIES - PharmaQuesT
ACCELERATED STABILITY STUDY Different formulations of the same dru are prepared.(Eg. Enalepril maleate As above F 1-F 4) Samples are kept at 400C / 75 % RH. Chemical stability is assessed by analyzing the drug content at regular interval.
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Regulatory Requirements Related to Stability Testing
pharmaquest.weebly.comKinetic Mean Temperature (Virtual temperature) 21°C 26°C 31°C 31°C . Mean Annual Relative Humidity 45% 60% 40% 70% REQUIREMENT OF TEMPERATURE DEPENDED ON TYPE OF TESTING TYPE OF STUDY TEMPERATURE RELATIVE HUMIDITY TIME DURATION Long term 25°C ± 2°C /60% RH ± 5% RH 12 months ...
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PHARMACEUTICAL PACKAGING, COMPONENT AND …
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pharmaquest.weebly.comThe processes involved in dissolution of solid dosage forms: ... Micronization of hydrophobic powders can lead to aggregation and floatation when powder is dispersed into dissolution medium. So, mere increase in S.A. of drug does not ... resulting in imparting hydrophilic character to granules & thus increase in effective surface area & rate of ...
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pharmaquest.weebly.comWhen the reaction rate is independent of concentration of the reacting substance, it depends on the zero power of the reactant and therefore is zero order reaction. In this type of reaction, the limiting factor is something other than concentration, for example, solubility or absorption of light in certain photochemical reactions.
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pharmaquest.weebly.com3. Solubility of solids in liquids 1.Solubility of gases in liquids Pharmaceutical solution of gases includes hydrochloric acid, ammonia water, and effervescent preparation containing carbon dioxide (Aerosol) that are dissolved and maintained in solution under positive pressure. The solubility of such system depends primarily on the pressure ...
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