This lecture was recorded as a part of the online university teaching (Faculty of Pharmacy, Pharos University in Alexandria). Degradation products are impurities resulting from chemical changes that occur during drug manufacturing. Several degradation products aren’t the inert, harmless substances many people believe them to be—in fact, they can cause adverse events, cancer, or other problems in some cases. Alarming as these degradation products are, there is also the physical stability of the drug to consider. Chemical Degradation. IMPORTANCE Chemical and physical degradation of drug substances may change their pharmacological effects, which is then affecting on their therapeutic and toxicological effect. Forced degradation is the process of subjecting drug compounds to extreme chemical and environmental conditions to determine product breakdown levels and preliminary degradation kinetics, and to identify potential degradation products. Lay abstract: Degradation products are impurities resulting from chemical changes that occur during drug manufacturing. This review deals with the concept of photostability and related aspects and the literature available in the field. These studies are carried out to ensure quality, efficacy, and safety of the formulated products during manufacture, storage, and use. They can also form during storage and … It is catalyzed by H+ and OH- ions. Following is the different pathways of chemical degradation: Hydrolysis, Racemization, Dehydration, Isomerization, Elimination, Oxidation, Photodegradation, Chemical incompatibilities, Isomerization 5. Pharmaceuticals products are used therapeutically based on … Enjoy the videos and music you love, upload original content, and share it all with friends, family, and the world on YouTube. Decarboxilation 4. Hydrolysis reaction between ionic species proceeds faster than neutral molecules. Polymerization 1. understanding and predicting the degradation and stability of drugs and chemicals Developing an understanding of the stability and degradation chemistry of candidate new drug substances and products, and identifying their potential degradation products are critical activities that are carried out during the of a drug’s development. It may also be possible to achieve stability by modification of the chemical structure of the drug. They are used They can also form during storage and transportation in response to changes in light, temperature, pH, and humidity, or due to inherent characteristics of the active pharmaceutical substance, su … More than just chemical stability. Photostability studies of drugs and drug products are an integral part of the product development process in the pharmaceutical industry. Oxidation 3. Hydrolysis 2. Therefore, it will undergo different forms of degradation. CHEMICAL DEGRADATION: Definition: “Change in the physical nature of the drug is called as chemical degradation.” Types: Types of chemical degradation are as under 1. DRUG DEGRADATION PATHWAYS CHEMICAL DECOMPOSITION. Hydrolysis: Definition: “It is defined as the reaction of a compound with water.” 1. Over time, the molecule goes through a self-degradation process to form NDMA. Ester groups break faster than amide. HYDROLYSIS Hydrolysis may be due to following reasons: Ester or amide groups react with one molecule of water and undergoes hydrolysis. Drugs is having several chemical natures along with different functional groups. That occur during drug manufacturing different forms of degradation than neutral molecules hydrolysis reaction between ionic proceeds! Degradation products are impurities resulting from chemical changes that occur during drug manufacturing concept of and! Amide groups react with one molecule of water and undergoes hydrolysis manufacture, storage, and safety the. 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