We provide forced degradation/stress studies that involve exposure of drug substances to heat, humidity and light for solid-state studies, whereas in solution form, stress studies are performed using acid-based hydrolysis and oxidation at various temperatures. The laboratory is equipped with a photostability chamber that provides photostability testing of drug substance and drug products as per

Polymorphism the property of the solid substance to exist in two or more crystalline forms. These forms differ in their physicochemical properties like solubility, stability, dissolution, flowability and hygroscopicity. Crystalline polymorphs although having the same chemical composition, have different internal crystal structures or lattice structures or different molecular conformations. Hence they have different physicochemical properties.

Elemental impurities are the impurities that can come along with the final drug product and can come through different ways either for the raw material source or through the process of synthesis or manufacturing. The common elements found are arsenic, mercury, cadmium, lead, catalysts and environmental contaminants that can appear through many ways even by

Research and development (R&D) in the pharmaceutical industry is the driving factor for the innovation and development of new drug entities to deliver them in the market. To develop a new drug the average cost is estimated to be around $2 billion. Larger investments and funding can create more potential therapeutic research work to provide

Extractables and leachables are compounds that can be extracted from the packaging containers or enclosed containers, manufacturing systems and medical equipment which can come in contact with the drug before it is administered to the patient. Extractables are generally compounds that in the presence of a solvent can be extracted from the container closure system.

Nitrosamine impurities are compounds that are found during the chemical reactions in the pharmaceutical drug product production. They are formed by the reaction of impurities present in the solvent system and the nitrite ions present in the acidic environment. Nitrosamine impurities contain a nitroso group at the dialkyl-substituted amine group. It is important to screen