Atorvastatin is the drug for lipid-lowering and preventing cardiovascular disease, including in the statin class of medication. Atorvastatin calcium tablets are sold as Lipitor under the brand name and Pfizer packages the medication in combination with other medications such as Atorvastatin / Amlodipine. Atorvastatin calcium in other countries is in the form of tablets by … Read more

The pharmaceutical manufacturers of APIs and the drug product have findings of nitrosamine impurities which may be likely because the human carcinogens in the drugs were of great concern. The detection of nitrosamine impurities was found in some of the commonly prescribed medicine used for the treatment of diabetes, antacids, and others. Some of the … Read more

In the pharmaceutical industry qualification and computer system validation is very important in order to control the quality of the final product and in a way it is a process that verifies the results, documentation, and validation activities which are as per the regulatory guidelines. The computer system validation is a systematic process as it … Read more

In the Pharmaceutical Industry, the Quality Management system (QMS) is an important aspect as the quality of the pharmaceutical products or the drugs is very critical and important as it defines the quality, purity, meeting specification, and safety which is finally involved when it is related to about life and in demand of today’s scenario. … Read more

Doxycycline is a tetracycline broad spectrum and an antibiotic for the treatment of bacterial infections. Doxycycline is also used to treat many diseases like Lyme disease, bacterial pneumonia, typhus, and chlamydia infections, and also for the various infection caused by gram-positive and gram-negative bacteria aerobes and anaerobes and also other types of bacteria. Doxycycline got … Read more

Elemental impurities affect drug effectiveness, it doesn’t have any therapeutic benefit but has a toxic effect on the patients. Elemental impurities may be present in drug products due to different sources such as catalysts, raw materials, excipients, equipment, or packing materials. As per recent necessities, elemental impurities guidance of ICH Q3D, USP Chapters <232>, made … Read more

The US Food and Drug Administration (FDA) finalized International Conference on Harmonization (ICH) guidance on DNA-reactive substances that could potentially cause damage when present at low levels and potentially cause cancer. A potential genotoxic impurity (PGI) has been defined as an “Impurity that shows a structural alert for genotoxicity but that has not been tested … Read more

Data integrity is an important and current top issue for many regulatory authorities these days as many pharmaceutical industries found multiple problems due to poor practices followed during the development and commercialization of products for the patients. In the current scenario, the data integrity has been extended throughout the life cycle of products with the … Read more

Importance of Relative Response Factor in Impurities Quantification Impurities are the constituent in a drug product that isn’t the drug substance or an excipient. Quantification of impurities in drug substances and drug products is achieved by HPLC. What is the Response Factor (RF)? The ratio between the concentration of a composite and its equivalent analytical … Read more