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Purify & Characterize Process Impurities

Analytical >> Analytical Method Development >> Impurity Isolation and Identification

Thanks to its innovative techniques (HPLC, SFC or combined preparative HPLC/SFC), DIVERCHIM proposes to its customers to isolate, purify and characterize process impurities as well as reference compounds.

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Impurity Profile Studies

Analytical >> Analytical Method Development >> Impurity Isolation and Identification

State-of-the-art R&D center is located in our Ankleshwar facility. Highly qualified professionals with the scientific bent of mind are working in product development, analytical development and intellectual property rights.

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Analytical Services for Material Characterization

Analytical >> Analytical Method Development >> Impurity Isolation and Identification

Dishman strives to provide a comprehensive portfolio of analytical services to facilitate this work. Analytical services support both process control and material characterisation for laboratory and production chemistry from initial raw material release to release of the final APIs.

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Assay & Purity Testing of products

Analytical >> Analytical Method Development >> Impurity Isolation and Identification

Our testing services are performed using USP/EP guidelines in compliance with FDA and DEA guidelines. Our laboratory is continually updated with new equipment to adapt to changing regulations and the ongoing needs of our clients.

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Impurity Isolation & Identification (Including GTIS)

Analytical >> Analytical Method Development >> Impurity Isolation and Identification

Ash Stevens has a dedicated and experienced analytical department providing comprehensive support from early-stage development to commercial API manufacturing.

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Impurity Profiling

Analytical >> Analytical Method Development >> Impurity Isolation and Identification

Sequent Research is a leading Contract Research Organization that specializes in Analytical and Bio Analytical Services to support the API, Pharmaceutical, Personal Care, Institutional and Nutraceutical companies.

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Purity Testing

Analytical >> Analytical Method Development >> Impurity Isolation and Identification

UPM’s analytical group has a diverse background in analytical method development and in-depth understanding of all facets of the drug development process.

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Impurity Profiling & Identification

Analytical >> Analytical Method Development >> Impurity Isolation and Identification

Globela Pharma Pvt Ltd has uplifted our existing R & D facility, and installed fully functioning in house R & D center- with state of the art infrastructure, and experienced, skilled manpower.

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Impurity Profiling & Validation

Analytical >> Analytical Method Development >> Impurity Isolation and Identification

Neuland is a leading manufacturer of active pharmaceutical ingredients (APIs) and an end-to-end solution provider for the pharmaceutical industry for chemistry related services.

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Gel Permeation Chromatography for Impurities

Analytical >> Analytical Method Development >> Impurity Isolation and Identification

CARBOGEN AMCIS state-of-the-art infrastructure includes process research and development (PR&D) laboratories, one laboratory dedicated to conjugation of small and large molecules and manufacturing capabilities.

Analytical testing is a critical part in every step of drug development and manufacturing. The qualitative and quantitative results generated from validated analytical testing provide first-hand information to control and ensure the quality and safety of raw materials, intermediates, and finished products. Like many other CMC (chemical, manufacturing and control) activities, analytical testing is also frequently outsourced. Many factors are attributed to this rapid market growth, including continuous outsourcing from pharmaceutical companies, growing pipelines for biological candidates, and increasing demand for more analytical details on drugs and process development by regulatory agencies. In response to the changing market dynamics, service providers are striving to provide analytical testing with quality, accuracy, and robustness all within tight timelines. As the contract research organizations (CROs) have become more integrated, small analytical labs need to establish their niche to succeed. Global contract anlytical Laboratories provide QC laboratory analysis, method development, validation and expert advice for both finished products and raw materials for pharmaceutical and biopharmaceutical companies. Impurity isolation and identification offers you critical information on the structure of your impurity, triggering synthesis efforts that contribute directly to CMC filings and better define conditions for the GMP synthesis process. PREPARATIVE SCALE IMPURITY ISOLATION APPLICATIONS include Structure Elucidation, Reference Standards and Toxicology Studies. Instrument & Detection Systems is done via SFC – Preparative & Analytical, HPLC – Preparative & Analytical, RPLC – Preparative & Analytical, UPC2, UPLC, GC/MS, ELSD, MS, CAD Detection, PDA/UV, NMR, Accurate Mass MS etc. Impurity synthesis and analysis is a very important step during the development of new drugs and pesticide. Pharmaceutical and pesticide impurities are chemicals, other than the main active ingredients, generated during the production, storage and other processes. The presence of the impurities affects the pharmaceutical, pesticide safety and the stability. So the drug production, storage and other processes must be strictly controlled to avoid the formation of impurities. The impurity is an important indicator of the quality control of drugs. Qualitative and quantitative analysis of impurities are always required in medicine, pesticide reporting, new product developments and quality control. CRO’s develop chromatographic and classic methods for the enhancement and isolation of critical impurities. Upon isolation of milligram quantities from the original source via HPLC or SFC, they use advanced spectroscopic techniques such as nuclear magnetic resonance (NMR), mass spectrometry (MS), Raman, infrared and ultraviolet. They apply these techniques directly or in conjunction with capillary NMR and hyphenated techniques such as LC/MS/MS, accurate mass and LC-NMR for fast, accurate identification of materials of interest. Upon identification of the target impurity, CRO’s offer scale-up processes for the isolation of gram quantities of impurities or degradants for use as reference materials. Relative response factors are also determined based on rigorous analytical testing. Extensive structural chemistry services for small and large molecules that include: Impurity and degradation product identification and structural elucidation, Characterization of API, product, reference standard and other pharmaceutical ingredients, Molecular weight determination for large biomolecules, Support for regulatory documentation for IND, MAA, DMF, Analytical reference standards qualification etc.

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