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GC Units with Head space for residual solvents

Analytical >> Analytical Testing Services >> Residual Solvents

Well-equipped laboratories performing comprehensive tests for the finished products, WIP, raw materials, equipment cleaning in compliance to ICH guidelines using Pharmacopoeial methods, In-house test methods and customer's requirements.

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Residual Solvents

Analytical >> Analytical Testing Services >> Residual Solvents

AMRI's analysts possess more than two decades of experience analyzing pharmaceutical products for residual solvents and can test products at any stage of development (raw materials, intermediate products and final products).

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Residual Solvents and Organic Volatile Impurities

Analytical >> Analytical Testing Services >> Residual Solvents

Arbro offers pharmaceutical testing and research services to support the development, approval, and manufacture of pharmaceutical raw materials and finished products. Arbro is listed on a number of leading pharmaceutical manufacturer’s licenses as the contract analytical testing site.

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Residual Solvents- 95% of GC Testing

Analytical >> Analytical Testing Services >> Residual Solvents

Residual solvents represent nearly 95% of GC testing at R.D. Laboratories. Residual solvents are trace level chemical residues that are used or produced in the manufacture of drug substances and excipients or in the preparation of drug products

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Residual Solvents

Analytical >> Analytical Testing Services >> Residual Solvents

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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Residual Solvents

Analytical >> Analytical Testing Services >> Residual Solvents

Eurofins BioPharma Product Testing has the wide range of chemistry expertise and state-of-the-art instruments required to perform all types of raw materials testing, including qualification of compendial methods, as well as development, qualification and validation of new methods.

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Residual Solvents

Analytical >> Analytical Testing Services >> Residual Solvents

We have systems capable of performing the current USP monograph for Residual Solvents using dedicated HS-GC-FID systems. We can also perform residual solvent analysis by headspace GC/MS.

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Residual Solvents Testing

Analytical >> Analytical Testing Services >> Residual Solvents

With a nationwide network of 29 environmental laboratories, 3 life sciences labs, 2 LabOps locations, and 46 service centers, Pace Analytical offers compendia (USP, EP, JP) methods of analytical services for qualitative and quantitative assessment of raw materials, APIs and Finished Products.

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Residual Solvents

Analytical >> Analytical Testing Services >> Residual Solvents

Primera specializes in customized analytical method development, transfer and validation using state-of-the-art analytical tools. We also provide cGMP Sample Storage and testing services. With no observations and no 483 findings from two FDA audits, We are in full compliance with GLP/cGMP regulations.

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Residual Solvent Analysis

Analytical >> Analytical Testing Services >> Residual Solvents

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.

Residual solvents in pharmaceutical products are defined as organic volatile compounds that are used or produced in the manufacturing of drug substances or excipients, or in the preparation of drug products, or from packaging and storage. Residual solvents are sometimes crucial in the synthesis of drug substances. Oftentimes, residual solvents are necessary to ameliorate the quality of drug substances or excipients. However, they are pitfalls and have no therapeutic value. Therefore, if the residual solvents are not completely removed by practical manufacturing methodologies, they must be evaluated and justified. Pharmaceutical products should contain low levels of residual solvents as determined by safety data. If the presence of residual solvents in pharmaceutical products exceeds tolerance limits as determined by safety data, they may be harmful to the human health and to the environment. That’s the reason that residual solvents testing becomes one of the important parts of quality control in pharmaceuticals. Contract Pharma Analytical Services providers offer residual solvent analysis programs for drug substances (APIs), drug products and excipients utilizing the U.S. Pharmacopeial Convention guideline (USP 467) for the design of its residual solvent studies. Individual customized programs are available. Residual solvent analysis is a very important QC procedure in the pharma industry. Sampling is typically performed by static headspace and analysis is done by GC/FID (flame ionization detector) using a dedicated column. GC/MS (mass spec) can also be used for residual solvent analysis. There are 3 classes of solvents: Class 1, 2 and 3. Class 3 solvents have a low toxic potential to humans. No long-term toxicity or carcinogenicity data are available for many of these substances. Class 2 solvents are non-genotoxic animal carcinogens. Solvents in this class should be limited in pharmaceutical products because of their inherent toxicity. Class 1 solvents (carcinogens) are strongly suspected of being both harmful to humans and environmental hazards. If possible, they should be avoided or at the least have their levels controlled. Testing of drug substances, excipients, and drug products for residual solvents should be performed when production or purification processes are known to result in the presence of such residual solvents. It is only necessary to test for residual solvents that are used or produced in the manufacture or purification processes.

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