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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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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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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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 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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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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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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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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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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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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Our integrated product development services help biopharmaceutical companies shorten time to market, manage risk and access new global markets to maximize portfolio value.

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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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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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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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Pace Analytical Life Sciences offers microbiology laboratory services for the qualitative and quantitative assessment of products, packaging and the manufacturing environment.

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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.

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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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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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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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GVK BIO offers a broad range of analytical services for complex research needs. We perform method development, validate and transfer Good Manufacturing Practice (cGMP) compliant methods for a broad spectrum of pharma compounds.

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GVK BIO offers a broad range of analytical services for complex research needs. We perform method development, validate and transfer Good Manufacturing Practice (cGMP) compliant methods for a broad spectrum of pharma compounds.