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

The impurity profiling of the drug product by using various analytical techniques in the pharmaceutical industry forms a crucial part in the drug development as it can also delay the drug development process. Identification of impurities and modification is done to ensure the safe and efficacious use of the drug product by the consumers. The

The risk analysis is a preliminary quantitative and qualitative process that evaluates the potential risk associated with the drug before administration. The benefit of the drug analysis has to overcome the risk assessment factor to be administered to the patient for its safety. When the drug is prescribed, the medical professional examines all the possible

India has enough competencies and expertise in augmenting the discovery and development of drugs and bringing out new innovative medicines into the market. Pharma research services in India have the expertise in analysing and managing the trends in the market and developing newer strategies to overcome the risks and challenges faced during the development of

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