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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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Residue Solvent (GC)

Analytical >> Analytical Testing Services >> Residual Solvents

Shijiazhuang Rainbowlabs pharmaceutical Technology Co. Ltd (Rainbowlabs) is a FDA-inspected laboratory set up to provide high quality laboratory testing and services to pharmaceutical companies throughout the world.

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Residual Solvents

Analytical >> Analytical Testing Services >> Residual Solvents

Trace analysis of impurities like organic, inorganic and residual solvents and their carry over in the finished product can be performed as per regulatory requirements. The report with suitability of the method along with the limits of detection and quantification.

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Residual Solvents By GC

Analytical >> Analytical Testing Services >> Residual Solvents

To help you achieve the desired quality and performance of your compound, Recro’s veteran scientists customize solutions for your complex products. Our team adheres to global ICH guidelines to ensure the development of safe, effective, high-quality pharmaceutical products.

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Residual Solvent Testing

Analytical >> Analytical Testing Services >> Residual Solvents

PYRAMID has over 4,000-sq. ft. of dedicated laboratory area with state of the art equipments. PYRAMID is a FDA registered Facility. All analyses are performed according to the applicable GLP and cGMP guidelines and regulations as documented in the Code of Federal Regulations (CFR) Title 21.

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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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Cleaning Residual Methods

Analytical >> Analytical Testing Services >> Residual Solvents

From early strategic investigative work on possible formulations to the development and implementation of methods and the generation of regulatory submission data, our team of experienced scientists will work – and communicate – with you at every step.

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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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Quantification & Qualification of Residual Solvents

Analytical >> Analytical Testing Services >> Residual Solvents

Neopharm has two distinct validation departments; chemistry and microbiology. Each validation department is dedicated to development, validation, verification, recovery and inter-laboratory transfer of analytical methods.

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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