Pharmaceutical Residual Rolvents Testing Labs

Medicilon provides expert, rapid analysis of all three classes of residual solvents. Our USP/ICH compliant, state-of-the-art laboratory, and experienced team of scientists allow you to manage the large number of methods that may be involved in identification and quantification of impurities, including residual solvents.

Whether you have impurities that are being introduced in upstream steps from culture growth and harvest, in the downstream processes, or through single-use technology, we have the breadth of capabilities and depth of industry knowledge to support all of your process validation testing needs.

• We have developed and qualified thousands of highly sensitive and selective methods that can help shorten your process validation timelines and minimize costs.

• Our history of cGMP regulatory compliance ensures delivery of the highest quality data.

• Our expertise in biochemistry, molecular & cell biology, virology and chemistry provides you with a single source for all of your validation testing needs.

Solvent Classification

Residual solvents are classified into three classes on the basis of the toxicity level and the degree to which they can be considered an environmental hazard. The list provided in the guideline is not exhaustive, and one should evaluate the synthesis and manufacturing processes for all possible residual solvents.

Class 1. Class 1 solvents are known carcinogens and are strongly suspected of being harmful to humans and of being environmental hazards. They should be avoided, if possible.  However, if using them to produce a medicinal product with a significant therapeutic value is unavoidable, then their levels should be controlled as shown in Table I, unless otherwise justified. 1,1,1-Trichloroethane is included in this table because it is an environmental hazard.

Class 2. Class 2 solvents are nongenotoxic animal carcinogens.  Solvents of this class should be limited in pharmaceutical products because of their inherent toxicity. Table II lists some of these solvents and their tolerable concentration limit. The limits were calculated on the basis of the permitted daily exposure, which assumed a daily dose of 10g of drug product per day.

Class 3. Class 3 solvents have low toxic potential to humans.  However, no long-term toxicity or carcinogenicity data are available for many of them. They have been found less toxic in acute or short-term studies and negative in genotoxicity studies. A concentration 0.5% is acceptable without justification. A higher amount may also be acceptable with proper justification.

Others. In addition to these three classes of solvents, some solvents may be of interest to manufacturers of active substances, excipients and drug products. However, no adequate toxicological data based on permitted daily dose are available. Manufacturers must provide justification if they use these solvents in their products.

Residual Solvents In Pharmaceuticals, commonly known as organic volatile impurities (OVIs), are chemicals that are either used or produced during the manufacture of active pharmaceutical ingredients (APIs), excipients and drug products. OVIs may also contaminate products during packaging, storage in warehouses and/or during transportation. Because residual solvents have no therapeutic benefits but may be hazardous to human health and the environment, it must be ensured that they are either not present in products or are only present below recommended acceptable levels.

Contact Us 

Email : marketing@medicilon.com
Tel : +86 021 58591500

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