A reference standard is a highly purified and well-characterized material suitable to test the identity, strength, quality, and purity of substances for Chemical, pharmaceutical, and medicinal products. Using reference standards, working standard can be prepared. Reference Standards can be taken from USP, EP, BP, and IP or In-house.
An impurity is “any component of the product which is not the chemical entity defined as the active substance or an excipient in the product”.
Drug Impurities are unwanted chemicals that remain with the active pharmaceutical ingredients (APIs) or develop during formulation or upon aging of both API and formulation. The presence of these unwanted chemicals even in trace amount may influence the efficacy and safety of pharmaceutical product. The control of impurities is an important task pharmaceutical impurities as per the regulatory norms. High Pure and Well characterized impurity Standards are used for Related Substances, Organic impurities and Validation of Analytical Methods.
Isotope Labelled Compound is a chemical substance in which part of the molecules are labeled with an isotope so that observations the isotopic composition make it possible to follow the compound or its fragments through physical, chemical, or biological processes. Isotopic labeling of compounds is a non-radioactive method of labeling, provides site-specific investigation of structures, makes molecules easily detectable by mass spectrometry and NMR, maintaining the physico-chemical properties of the target molecule, and is cost-effective and easy to use.
For Example Deuterium is a non-radioactive isotope of hydrogen that is a different atom than hydrogen. High Pure and well characterized Deuterated Compounds and Isotope Labelled Compounds are used as Internal Standards in Bio-Analytical BA/BE Studies.
A metabolite is the intermediate end product of metabolism. The term metabolite is usually restricted to small molecules. A drug metabolite is a byproduct of break down, or “metabolizing,” a drug into a different substance.
Estimation of Drug metabolites in the blood is an essential part to understand the distribution of drug in the blood. High purity, well characterized drug metabolite standards are required for Bio-Analytical BE/BA Studies.
Some metabolites stay in the body much longer than the parent drug. When that is the case, a drug test has a higher probability of identifying a drug user by looking for the metabolites of the drug, rather than the parent drug.
Research chemicals are chemical substances used by scientists for scientific research and development purposes. Research Chemicals are produced by Custom Synthesis Methods.One characteristic of a research chemical is that it is for laboratory research use only; a research chemical is not intended for human or veterinary use.