Nitrosamine impurities
We have expertise in the synthesis of various rare and complex impurities of nitrosamine Or N-nitroso amine impurities. The nitrosamine impurities which are probable human carcinogens. Therefore, to avoid presence of nitrosamine impurities from human medicines and APIs.
The formation of nitrosamines is generally only possible when secondary or tertiary amines react with nitrous acid. Nitrous acid is unstable but can be formed in situ from nitrites (NO2) under acid conditions.
Synthesis of known pharmacopeial inhouse Impurities or Analytical standards.
We have vast experience in the synthesis of complex molecules and we are able to provide in-house pharmacopeial impurities to our clients and fulfill their regulatory requirements. We have more than 5,000 pharmacopeial in-house impurities are in stock.
We need to confirm the structure of impurities by EP/BP/USP followed by a check the purity by the method of HPLC analysis which is mentioned in pharmacopeia.
Custom synthesis and CRAMS related projects.
Alentris Research Pvt Ltd is a leading company in the custom synthesis field, with extensive experience in managing impurities during the scale up at Kilogram scale during synthesis process.
The company’s team has specialized knowledge in organic synthesis, analytical chemistry, and process development. The company’s quality control team uses advanced analytical techniques, such as NMR spectroscopy and mass spectrometry, to ensure that the final product meets the client’s specifications.
Synthesis of API & intermediates.
Our expertise in the synthesis of antifungal category drugs and related key intermediates as well as anticoagulant category drugs with high-quality compliance products.
Developed innovative routes for the manufacturing of key advanced intermediates. The synthesis of APIs (Active Pharmaceutical Ingredients) and intermediates is a crucial aspect of the pharmaceutical industry.
Integrated drug discovery projects like - FTEs, FFS.
Synthesized capability up to mg scale to gm scale and kg scale. Deliver the compounds with complete characterization data like – 1H NMR, Mass, LC-MS, HPLC, etc.
We have a wide range of chemistry expertise like – heterocyclic chemistry, peptide chemistry, carbohydrate chemistry, chiral chemistry, fragment library chemistry, etc.
Analytical services.
We specialize in precise analytical services, including mass analysis, LCMS analysis, HPLC analysis, and Prep HPLC purification. Our state-of-the-art equipment and experienced team guarantee accurate results for your analytical needs, ensuring product safety and quality.
In addition, we offer in-house validation and nitrosamine impurity analysis, working closely with you to meet regulatory requirements and maintain top-tier quality standards. With us, you can trust in efficient and reliable analytical solutions to drive innovation and success.
