October 17, 2020

Difference Between LC, LC-MS, LC-MS-MS, and HR-MS

What is LC? Liquid chromatography (LC) is fast and effective separation technique for the constituent of a mixture and purification of compounds. It is based on […]
August 29, 2020
Considerations for pharmaceutical product lifecycle management

Technical & Regulatory considerations for Pharmaceutical Product Lifecycle Management

Introduction  Product Lifecycle Management(PLM) is the route of handling the entire lifecycle of a product from its beginning, through product machine design and manufacturing procedure, to […]
August 28, 2020
Qualification of Pharmaceutical Working Standard

Qualification of Pharmaceutical Working Standards

The certified standard is very much important in pharmaceutical analysis. It ensures that the performed analysis is accurate and assure the safety of drug product. The […]
August 27, 2020
Nitrosamine impurities in phrmaceuticals and foods

Nitrosamine Impurities in Pharmaceuticals & Foods

Overview Nitrosamines are general organic complexes and found often in foods, vegetables, rubber products, pharmaceutical products, and even in water in trace levels. Nitrites found in […]
August 26, 2020
Data integrity and its Compliance

Data integrity and its Compliance

Introduction In the Pharmaceutical industry, data Integrity plays a pivotal role as it judges the safety and quality of pharmaceutical products. Data Integrity (DI) is very […]
August 25, 2020

Different Types of Isomeric Impurities Present in Pharmaceutical Products

Isomers are complexes with identical molecular formulas but different arrangements and activities. Isomers of similar compounds have likely to own dissimilar chemical or physical properties which can […]
August 24, 2020
Importance of Relative Response Factor in Impurities Quantification

Importance of Relative Response Factor in Impurities Quantification

Impurities are the constituent in drug product which isn’t the drug substance or an excipient. Quantification of impurities in drug substance and drug product is achieved […]
August 22, 2020
Image for Separation of Closely Eluting Impurities by Selecting Appropriate Stationary Phase

Separation of Closely Eluting Impurities by Selecting Appropriate Stationary Phase

Background HPLC column is the heart of HPLC hence selecting the appropriate stationary phase is the most important part of method development. The selection of the […]
August 21, 2020
Drug master file DMF

Review on Drug Master File (DMF)

Introduction Drug master file (DMF) is a submission to Food and Drug and Administration (FDA) and is a kind of confidential document which contains detailed information […]