Alentris Research Pvt. Ltd. – API Impurities & Contract Research Organization

Pharmacopeial Inhouse Impurities

We have vast experience in the synthesis of complex molecules and we are able to provide in-house pharmacopeial impurities to our clients and fulfil their regulatory requirements.

Welcome To Alentris Research

Alentris is the organisation which built by the scientist and driven by their team members, values, delivery commitments, attention to details, technology, innovation, discovery, community, social responsibility.

Nitrosamine Impurities

We have expertise in the synthesis of various rare and complex impurities of nitrosamine Or N-nitroso amine impurities.The nitrosamine impurities are probable human carcinogens.

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.

Pharmacopeial Inhouse Impurities

We have vast experience in the synthesis of complex molecules and we are able to provide in-house pharmacopeial impurities to our clients and fulfil their regulatory requirements.

Welcome To Alentris Research

Nitrosamine Impurities

We have expertise in the synthesis of various rare and complex impurities of nitrosamine Or N-nitroso amine impurities.The nitrosamine impurities are probable human carcinogens.

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.

Pharmacopeial Inhouse Impurities

We have vast experience in the synthesis of complex molecules and we are able to provide in-house pharmacopeial impurities to our clients and fulfil their regulatory requirements.

Alentris Research Pvt Ltd was founded by the two scientists in Year 2017. Alentris Research are having more than 100 years of experience in synthetic organic and Medicinal chemistry. We are having 4500 square foot area for research and development facility is available at Dehgam Area. At Alentris we, manufacture the API Impurities, API Intermediate and novel customise scaffolds. We are having hands on experience on peptide, carbohydrate and heterocyclic chemistry.

Alentris research having experience team which is help the customers for isolation and characterisation of Unknown impurities. World class R & D and analytical facilities like Mass, HPLC, LCMS, Prep HPLC, Lyophilization, Flash purification technique, fume hoods and latest infrastructure. Team Alentris having expertise in custom synthesis well as CRO, CRAMS and integrated drug discovery projects.

We have made significant strides in expanding our operations and capabilities. Our global presence grew as we successfully entered international markets. With the completion of key milestones, we launched advanced facilities for API synthesis, setting the stage for future innovations. Our commitment to research led us to establish a dedicated R&D facility, which has since been upgraded to a larger, state-of-the-art space to accommodate our growing needs. The installation of cutting-edge analytical equipment, including our first LCMS, has further enhanced our research capabilities. This progress is supported by a talented and expanding team, all working toward achieving ambitious goals. Together, we are building a strong foundation for continued success and growth.

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.

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.

Nitrosamine impurities

Synthesis of known pharmacopeial inhouse Impurities or Analytical standards.

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.

Synthesis of API & intermediates.

Integrated drug discovery projects like - FTEs, FFS.

Analytical services.

At, Alentris Research we provide the solution to our client in very efficient manner. We will provide the analytical impurities and unknown impurities.

In Unknown impurities:

We will increase the formation of impurities by many ways to understand their Degradation Profile such as Hydrolytic Product, Oxidation Product, Photolytic Product, Thermal Degradation Product, Major degradation product, Adduct impurities, Cyclization Impurity, Acid impurity, Base impurity, Impurity Profiling, Synthesis-related impurities, Formulation-related impurities and Metabolite impurities, peptide unknown impurity and Nitrosamine Drug Substance-Related Impurities (NDSRIs).

Some of Examples are below,

Norepinephrine Unknown Impurity Isolation and Characterisation of highly polar compound having stability issues.

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