API Impurity Isolation

During a manufacturing process or a stability study for an Active Pharmaceutical Ingredient (API) or drug product, a sample may be found to contain impurities. These impurities might occur as degradation products, as intermediates/process impurities originating from the synthetic route, as an unwanted by-product of side-reactions or due to contamination of the original sample. Such […]

Continue Reading

Impurity quantification in pharmaceutical dosage forms

Identification and quantification of impurities in drug compounds is a crucial task in pharmaceutical process development for quality and safety. Related components are the impurities in pharmaceuticals which are unwanted chemicals that remain with the active pharmaceutical ingredients (APIs), or develop during stability testing, or develop during formulation or upon aging of both API and […]

Continue Reading

Identifying and eliminating impurities in API manufacturing

Potential toxic chemicals and carcinogens in treatment drugs are one of the biggest problems to plague Active Pharmaceutical Ingredient (API) manufacturing. Because of this, one of the most important tasks of any manufacturer is to identify impurities before they impact the quality, efficacy and safety of drugs, as well as cause costly project delays. Analyzing […]

Continue Reading

The control of API impurities – A critical issue to the pharmaceutical industry

In the present era, there is a tremendous upsurge for impurity profiling of pharmaceutical products. Presence of impurities in trace quantity in drug substance or drug product is inevitable. Therefore, their level should be controlled and monitored. They can reinforce or diminish the pharmacological efficacy of the Active Pharmaceutical Ingredient (API). Sometimes, the effect produced […]

Continue Reading