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Isolate, Purify & Characterize Reference Substance

Analytical >> Analytical Method Development >> Reference Substances / Qualification

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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Reference Standard Qualification

Analytical >> Analytical Method Development >> Reference Substances / Qualification

KriSan Biotech offers world class services of new drug process and analytical R&D for small molecules and peptides from Pre-clinical (IND) to Phase II.

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Reference Standard Characterization

Analytical >> Analytical Method Development >> Reference Substances / Qualification

We provide full range of analytical services, State-of-the-art instruments, cutting-edge technologies, and experienced scientific staff ensure efficient, high-quality and cost-effective services.

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RLD Evaluations

Analytical >> Analytical Method Development >> Reference Substances / Qualification

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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Reference Standard Management

Analytical >> Analytical Method Development >> Reference Substances / Qualification

Sequent follow ICH guidelines for cost effective standard characterisation with CoA; assure each standard fit for use in method validations/sample analysis/PK studies /product release.

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Reference Standard Qualification

Analytical >> Analytical Method Development >> Reference Substances / Qualification

Acceleration Laboratory Services is the foremost Contract Solutions Provider for the pharmaceutical research. The ultimate goal for our associates is to deliver superior solutions to our clients, on time, and on point, while maintaining a fun and empowering work environment.

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Reference Materials

Analytical >> Analytical Method Development >> Reference Substances / Qualification

Merck offers a range of first-class reference materials for analytical methods under the trade name Certipur®, all of which are traceable to international standards.

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Reference Standards

Analytical >> Analytical Method Development >> Reference Substances / Qualification

We have a large number of Anaytical Reference Standards available in stock for delivery

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Reference Standard Characterization

Analytical >> Analytical Method Development >> Reference Substances / Qualification

Our laboratories, equipped with the most modern instrumentation is operated by a well trained and highly motivated staff with an average of over 10 years of practical experience. The Pharmaceutical Analytical Laboratory is GMP inspected and under control of the respective authorities.

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Reference standard qualification and maintenance

Analytical >> Analytical Method Development >> Reference Substances / Qualification

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

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. The US Food and Drug Administration defines a reference-standard material as a "highly purified compound that is well characterized" . The US Pharmacopeia (USP) defines reference-standard materials as "highly characterized specimens of drug substances, excipients, reportable impurities, degradation products, compendial reagents, and performance calibrators". Scientists performing analytical testing use reference standards to determine quantitative (e.g., assay and impurity) as well as qualitative (e.g., identification tests) data, performance standards, and calibrators (e.g., melting point standards). The quality and purity of reference standards, therefore, are critical for reaching scientifically valid results. Reference standards can be segregated into two groups: chemical and nuclidic. Chemical purity must be determined for both groups; nuclidic reference standards, however, also need to be evaluated for radionuclidic and radiochemical purity. Reference-standard materials can be broadly categorized as such: Assays—used to determine potency for active pharmaceutical ingredients (APIs) and salts, Degradation products—used to identify and possibly to quantitate degradation products, Process impurities—used to identify and possibly quantitate process-related compounds, Resolution—used to determine assay performance or impurity method and Metabolites—used to identify and possibly to quantitate substances generated through a metabolic process. The level of characterization depends on the intended use of the reference standard. For example, a reference standard used to determine potency requires full characterization and qualification. A reference standard used as a resolution component or identification requires less discerning analyses.

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