Assessment of Genotoxic Impurities

Assessment of Genotoxic Impurities

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 – General consideration and current understanding of the Pharmaceutical industry

Data Integrity – General consideration and current understanding of the Pharmaceutical industry

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

Determination of Response factors of Impurities in Drugs by HPLC

Determination of Response factors of Impurities in Drugs by HPLC

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

Evaluation of Out of Trend (OOT) Results

Evaluation of Out of Trend (OOT) Results

What is Out-of-Trend (OOT)? The analytical results are within the specification but not inside the expected trend related to the initial result or anticipated result. OOT specifies that there may be something incorrect with the analysis or manufacturing process. If the assay of 2nd month stability study found 95.5% (Specification: 105. 0 % to 95.0 … Read more

Use of NMR in Impurity Profiling for Pharmaceutical Products

NMR in Impurity Profiling for Pharmaceutical Products

Nuclear Magnetic Resonance Spectrometry (NMR) is the best instrument technique in the pharmaceutical for the identification and characterization of impurities. NMR is also called proton NMR since it gives structural clarification based on the number of proton pairs present in the structure. The key use of NMR spectroscopy is that it gives identification and molecular … Read more

Importance of Mobile Phase Buffer Selection for HPLC to LC-MS

Importance of Mobile Phase Buffer Selection for HPLC to LC-MS

Considering the more complex products analytical scientist needs to develop a specific, accurate, robust stability-indicating analytical method. At the time of method development, analytical scientists need to focus on the development of the mass-compatible method. At the start of method development, it is important to have systematic information about the sample. Selection of Buffers for … Read more

Drug-Excipient Compatibility Study

Drug Excipient Compatibility Study

What is drug-excipient compatibility? Drug-excipient compatibility study is a very much important stage of formulation development of drug products in combination with excipients. It’s a significant phase of the pre-formulation study. Drug product not only contains active pharmaceutical ingredient (API) but it’s a combination of different forms of excipients. it’s important to study the physical … Read more

What is Out of-Specification Investigation and How to Proceed for it?

What is Out of-Specification Investigation and How to Proceed for it

FDA issued a warning letter to most drug substances and drug product manufacturers. During the inspection, FDA find out the fault, the way the investigation of OOS had been carried out by the manufacturer. There is no proper investigation of the OOS outcome. FDA warning letters often found that the procedure for handling OOS is lacking or … Read more

Overview of Scale-Up and Post-Approval Changes (SUPAC)

Overview of Scale-Up and Post-Approval Changes (SUPAC)

The development of an increase in batch size from small scale to large scale is termed scale-up. This process is required in-depth study and knowledge about the product which needs to be manufactured at a large scale. It’s important to make sure that the applied process is capable enough to manufacture an appropriate quality product. … Read more