by inpharmedia | Dec 18, 2023 | Blog, Product Development
The Bacterial Endotoxin Test (BET) detects or quantifies endotoxins from gram-negative bacteria using amoebocyte lysate from the horseshoe crab (Limulus polyphemus or Tachypleus tridentatus). Endotoxins are components of gram-negative bacteria’s outer cell...
by inpharmedia | Nov 18, 2023 | Blog, Regulatory
The Food and Drug Administration (FDA) is the federal system that approves any drug related to humans. The Agency provides the sufficient information that enables the sponsors and industry to gather the data and requirements from time-to time. These data can be used... by inpharmedia | Oct 21, 2023 | Blog, Product Development
The FDA guidance discusses on quality considerations for ophthalmic drug products (i.e., solutions, suspensions, emulsions, gels, ointments, and creams) intended for topical delivery in and around the eye. The guidance specifically discusses on: Approaches to...
by inpharmedia | Sep 9, 2023 | Blog, Product Development, Regulatory
Any drug substance or drug product has to maintain the same quality, safety and efficacy throughout the lifecycle of a product. Generally, the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such... by inpharmedia | Aug 15, 2023 | Blog, Product Development, Regulatory
Solvent – A substance, majorly liquid capable of dissolving or diluting other substances to form a solution. Generally, several solvents are used in the manufacturing of drug substance, excipients and drug products as a routine practice. The solvents are used to...
by inpharmedia | Jul 24, 2023 | Blog, Product Development, Regulatory
Every product should have a sufficient level of quality to ensure its efficacy and safety. The impurities/degradation products are the ones that arise during different stages of synthesis, manufacture and storage. They should be controlled at certain level to maintain...
