A reference standard of active pharmaceutical ingredient that has been fully characterized to be used as a standard for manufacturing / finished products / research needs of API.
An intermediate which is a regulatory starting material manufactured as per the cGMP manufacturing process – which meets all the requirements of regulatory bodies (quality & regulatory documents) as well as supporting the customers throughout the lifecycle of API manufacturing with all documents/process impurities etc.
Polymorphism is often characterized as the ability of a drug substance to exist as two or more crystalline phases that have different arrangements and/or conformations of the molecules in the crystal lattice. A reference standard of that has been fully characterized to be used as a Polymorph standards for research needs. (Picture of XRD or TG or IR)
Synthetic products which has been identified/fully characterized to be used as referecence standard as per the regulatory requirements to be used as standards for the R&D, Production of API’s or finished products.
Chemical transformations of Active pharma ingredients compounds form new metabolic products with distinct spectroscopic signatures.
The stable deuterium labeled molecule (drug or drug metabolite) are the best internal standard for bio analysis study. We provide labeled products of high quality with complete interpretation data.
PGIs are reactive compounds that can induce genetic mutations by reacting with DNA. If a PGI is present in an active pharmaceutical ingredient (API), it can potentially cause cancer in the patient.
A reference standard of an impurity in the active compound or intermediate that has been fully characterized to be used as a standard.