Drug Metabolite Impurities, Pathways & Analytical Techniques

 Metabolites are the intermediate products of metabolic reactions catalyzed by various enzymes that naturally occur within cells. The term metabolite is usually used for small molecules.

Metabolites forms may be integral or pharmacological and formed during the natural biochemical process of degrading and eliminating the compounds from chemical compounds. It is important to know how the drug products are metabolized and what are its probable side effects. e.g. Sugars are metabolites into fructose or glucose, which are both present in the metabolic pathways.

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Evaluation of Photodegradation Pathways

 Photostability study provides useful information about the handling and packing of drug substance and drug products.

Most of the drug substances are light-sensitive hence during formulation it may degrade at the time of processing, manufacturing, and storage. Due to photodegradation, there may be a chance loss of potency, impact on efficiency, and harmful biological properties.

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Patenting in the Indian Pharmaceutical Industry

 Indian Pharmaceutical Industry is considered highly progressive in the field of drug manufacturing and technology. Today India has the global presence in the field of generic drugs and hence protecting the new drugs combinations and its process by means of intellectual property rights (IPR).

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Impurity Profiling in Drug Development

 Impurities in pharmaceuticals are unwanted chemicals that remain with the active pharmaceutical ingredients (APIs) or develop during formulation or upon aging of both API and formulation. In the pharmaceutical industry, an impurity is considered as any other inorganic or organic material, or residual solvents other than the drug substances, or ingredients, that arise out of synthesis or unwanted chemicals that remains with APIs. The presence of these unwanted chemicals even in trace amount may influence the efficacy and safety of pharmaceutical product.

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Forced Degradation Studies for Drug Substances and Drug Products- A Regulatory Considerations

 Various regulatory guidance is available which provides useful definitions and general comments about degradation studies. However, guidance concerning the scope, timing, degradation condition, and best practices for degradation studies is very general. Various issues related to stress testing are addressed in numerous guidance documents but not always in the context of stress testing. Therefore, stress-testing conditions should be realistic and not excessive.

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Potential Impurities in Drug Substance & Drug Products

 Potential impurities are the substance which are formed during the reaction or already present in the form of starting materials, by-products, or intermediate products. Potential Impurities have no therapeutic value and are potentially harmful.  Therefore, they need to be controlled.

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Nitrosamine Impurities Trace in Metformin

 Metformin is a prescription drug used to control high blood sugar in patients with type 2 diabetes. The Regulatory agency announced that traces of Nitrosamine present in generic drug substances and drug products, further FDA and EMA investigation also led to the detection of these Nitrosamine impurities in low levels of NDMA impurity in Metformin.

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