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
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
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
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
Hydroxychloroquine, a derivative of Chloroquine, has been used for years in the treatment of malaria. The drug is also known to block the entry of many viruses into cells. A small clinical trial has revealed it to be effective in reducing viral loads in COVID-19 patients. Enveloped viruses enter into a host, eventually fusing their … Read more
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
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
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 … Read more
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
The sources of impurities in pharmaceutical drug products and drug substances can be assigned to the drug substance or inert ingredients which are used for the formulation of a drug product. Sources of impurities can also be brought into the drug product during the formulation process or through contact with the packaging. The impurities formation … Read more
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