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  • Nitrosamine Impurities and the Sartans

    Nitrosamine Impurities and the Sartans

    Medicine Regulatory Authorities first became aware of the presence of the nitrosamine impurity, N-nitrosodimethylamine (NDMA), in products containing valsartan in July 2018. Valsartan is an Angiotensin II Receptor Blocker (ARB) and belongs to a family of analog compounds commonly referred to as the sartans. Further nitrosamine impurities were subsequently detected in other medicines belonging to … Read more

    A Glimpse on Quality by Design (QbD) Approach in Pharmaceutical Industry

    Quality-by-Design approach in Pharmaceutical Industry

    The concept of Quality by design (QbD) means signifies designing and developing pharmaceutical products and manufacturing processes to ensure predefined product quality objectives. Quality by Design (QbD) brings a systematic approach to drug development that aims to ensure quality by applying analytical and risk-management methodologies to design, development and manufacturing. The main concept of (QbD) … Read more

    Recent Control and Testing Strategies for Genotoxic Impurities

    Recent Control and Testing Strategies for Genotoxic impurities

    A short review of Recent Control and Testing Strategies for Genotoxic impurities Analytical Method development and routine QC analysis for the determination of Genotoxic impurities (GI) at trace levels present exceptional challenges to pharmaceutical development and QC laboratories. These impurities are required to be controlled at trace levels in new drug substances and drug products. The International Conference … Read more

    Classification of Pharmaceutical Drug Impurities

    classification of impurities in pharmaceutical drug products

    Impurities in pharmaceutical drug substances: Impurities are defined as a foreign particle that affects the purity of a substance. Usually, impurities occurring in many pharmaceutical or medicinal preparations may be of different types. Types of Impurities in pharmaceutical drug substances: According to the ICH, guideline impurities are classified as organic impurities, inorganic impurities, and residual solvents. Basically, Veeprho involves … Read more

    Effect of Hydroxychloroquine on COVID-19

    Effect of hydroxychloroquine on COVID-19

    What is Hydroxychloroquine? CAS Number – 118-42-3Molecular Formula – C18H26ClN3OMolecular Weight – 335.872 g/mol Hydroxychloroquine is a disease-modifying anti-rheumatic drug (DMARD). It regulates the activity of the immune system, which may be overactive in some conditions. Hydroxychloroquine can modify the underlying disease process, rather than simply treating the symptoms. Recent studies have shown that both … Read more

    Control of Pharmaceutical Impurities in Pharmaceutical Drug Products

    Control of pharmaceutical impurities in drug products

    Impurities in pharmaceutical products do not offer any therapeutic benefit for the patient and sometimes they are potentially toxic. The impurity level is a critical quality attribute for a drug substance or a drug product. Impurity control is one of the most important tasks in a process scale-up. Pharmaceutical impurities can be controlled by understanding … Read more

    Impurity Profiling in Drug Development

    Impurity-Profiling

    Impurities in pharmaceuticals are unwanted chemicals that remain with the active pharmaceutical ingredients (APIs) or develop during formulation or upon ageing 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 … Read more

    Impurities in Pharmaceutical Drug Substances

    Impurities-in-pharmaceutical-drug-substances

    Impurities are defined as foreign particle that affects the purity of a substance. Usually, impurities occurring in many pharmaceutical or medicinal preparations may be of the following types. 1) Types of pharmaceutical drug substances: There are several types of drug substances (Medicine) in the world of medicine like  The major, main and important content of the … Read more

    Sources of Impurities in Pharmaceutical Substances

    Sources of Impurities in Pharmaceutical Substances

    The sources of impurities in pharmaceutical drug products and drug substances can be assigned to the active ingredients or inert components used in formulation. Impurities can also arise during the formulation process or through contact with the packaging. The formation of impurities may take place either in drug substances or drug products, often during intermediate … Read more