Molecules exist in nature in any of the three states viz., solid. liquid and vapour. But most of the molecules, organic and inorganic , exist in solid states. It is very interesting that if these solid state molecules have therapeutic benefits, they’re used as a drug substance. In a solid state, the molecules or the elements exist as crystals which are oriented in a organised or disorganised ways. Hence multiple orientations are possible for a molecule. In a pharmaceutical drug, these different crystalline orientations are named as Polymorphs. Polymorphism may be defined as the ability of a compound to crystallize in two or more crystalline phases with different arrangements and/or conformations of the molecules in the crystal lattice. Hence, polymorphs are different crystalline forms of the same pure chemical compound. Since these crystalline forms are oriented differently, their free energies are also different which makes them as uniq...
Chemical stability of pharmaceutical molecules is most important as it has impact on the safety and efficacy of the drug products. Stress testing or forced degradation is an analytical tool to study the behaviour of the products as well as to understand the resolving power of the analytical method used. Stress testing reveals the quality of pharmaceutical products exposed over the time period as well as different environmental conditions viz., heat, hydrolysis, oxidation, photolytic etc. ICH guideline defines stress testing as: Studies undertaken to elucidate the intrinsic stability of the drug substance. Such testing is part of the development strategy and is normally carried out under more severe conditions than those used for accelerated testing. Stress studies provides more valuable information about the degradation impurities, called as degradants, which are likely to form during the shelf life of the product lifecycle in a very short period compared to...
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