Puritan Labs Private Limited

In their own words

Puritanlabs is a research based, innovation driven organization offering a comprehensive range of high-quality Reference Standards, Impurities, Deuterated & Labelled Compounds, Metabolites, Chiral Compounds & Conjugate Impurities. Puritan Labs Private Limited has come a long way ever since, transcending industrial and vertical boundaries. We supply reference standards worldwide to a client base that includes major biotechnology corporations, pharmaceutical and diagnostic companies, clinical and bio-analytical CROs, manufacturers of specialty chemicals, as well as to Hospital researchers, universities and various other research institutions Right from pharmaceutical APIs impurities and intermediates impurities, formulations impurities, synthesis of complex impurities (Reference standards, Working Standards, Impurities, Deuterated Compounds, Labelled Compounds, Metabolites, Chiral Impurities, NCE impurities, Pharmacopeia impurities, Non-pharmacopeia impurities, Formulation impurities, Complex impurities, Reference chemicals, USP standards, ICH impurities) We are well accepted and appreciated by the industry. Puritan Labs Pvt ltd has strong presence in Custom Synthesis & is managed by a blend of highly experienced and young talent who excel in Impurity synthesis. On a need base module, we also develop method & Synthesis compounds as per the desired specification provided by the customer adhering to the highest standard of Quality, Service and most off all confidentiality. Puritan Labs Pvt ltd possesses a unique combination of Quality, Technical Skills and our vast knowledge of untapped market. Therefore, we are the best partner for Custom Synthesis in India The control of pharmaceutical impurities is currently a critical issue to the pharmaceutical industry. Structure elucidation of pharmaceutical impurities is an important part of the drug product development process. Impurities can have unwanted pharmacological or toxicological effects that seriously impact product quality and patient safety. Potential sources and mechanisms of impurity formation are discussed for both drugs. The International Conference on Harmonization (ICH) has formulated a workable guideline regarding the control of impurities Impurities in pharmaceutical products are the unwanted chemicals that remain with the active pharmaceutical ingredients (APIs), or develop during formulation, or upon aging of both API and to medicines. The presence of these impurities even in trace amounts may influence the efficacy and safety of the pharmaceutical products. Identification and quantification of impurities (Impurity Profile) is now becoming important critical product quality parameter and getting critical review from regulatory authorities. Because of this, limit and threshold values for impurities are specified by pharmacopoeias and ICH guidelines. Analysis of impurities according to this set of specifications is mandatory for the pharmaceutical product release for the human consumption. Impurity Profile study is also very important for market approval for finished dosage forms from regulatory authorities As a company founded by highly experience R&D professionals & researchers, we recognize the inextricable connection between the quality of tools and practices and the success of research. All our services are delivered according to strict ICH-GMP/ GLP guidelines and are accompanied with certificates of analysis. Complementing to our full commitment to quality, we allocate uncompromised resources to innovate best practices and tools that fosters the drug discovery and development. At Puritan Labs Pvt Ltd we are committed to Quality and timely deliverance of the assignments undertaken by us. We work in close co-ordination with our customers to accomplish the assignments.

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