Testing should be performed for those residual solvents that are used or produced in the manufacture or purification of drug substances, excipients or drug. Where the limits to be applied comply with those given below, tests for residual solvents are not generally mentioned in specific monographs, because the. Pharm Res. Mar;20(3) Residual solvent testing: a review of gas- chromatographic and alternative techniques. B'Hymer C(1). Author information.
Testing Residual Solvents
From cleaning assembly line equipment to engineering pharmaceutical products, solvents play a role at many different stages in the manufacturing process. However, if they are not properly removed, residual solvents can compromise the quality or safety of a product. Taking advantage of residual solvent testing is a way to combat potential quality issues and ensure a safe product. A solvent is a liquid or gas that dissolves or extracts other substances.
Some of the most common solvents used in manufacturing include butane, ethanol, propane, hexane and acetone. Solvents can be used to clean electronics and tools, dissolve greases and oils, or mix or thin pigments. Solvents are also very important for the creation of drugs and other pharmaceutical products.
For example, solvents are often used at the beginning of the manufacturing process to create the active ingredients for ointments and other topical products. Residual solvents are solvents that are used in the manufacturing of materials that are not completely removed after processing. Sometimes solvents are a critical part of the actual makeup of the product. For example, solvents can be used in glue and adhesive manufacturing to control the drying properties.
However, there are guidelines for the amount of residual solvents that can be left behind and still be considered safe. At unsafe levels, they can either be harmful to the environment or humans. For example, removing cleaning solvents is essential during the processing of a circuit board. It can also determine whether the proper solvent purging process was followed during product development. For example, ethanol and other solvents are often used in the production of pharmaceutical products. Here, a safety factor of 2 doesn't need to be taken into account.
In borderline cases, this could lead to a situation where after similar implementation, a sample meets the requirements of the USP but does not however comply with the criteria of the Ph. Read the unabridged version in our technical article or browse through topics that might be of interest to you.
All instrumental resources at a glance. Can we help you further? We will be happy to advise you! Where do solvent residues come from? Class 3 residual solvents solvents of low toxicity Class 2 residual solvents limited solvents Class 1 residual solvents solvents to be avoided The requirements on the analysis methods increase with the increasing potential for danger.
Class 3 residual solvents Depending on their toxicity, these solvents can be defined as sum parameters by investigation using loss on drying. Class 1 residual solvents solvents to be avoided Solvent Concentration Limit ppm Concern Benzene 2 Carcinogen Carbon tetrachloride 4 Toxic and environmental hazard 1,2-Dichloroethane 5 Toxic 1,1-Dichloroethene 8 Toxic 1,1,1-Trichloroethane Environmental hazard.
Analytical challenges and general trends A number of different measurement methods are used because of the large number of matrices and analytes. The main differences in the evaluation of the results between the Ph. When is validation necessary? When it deviates from the statutory limit values - either above or below.
If the sample is not completely dissolved and so another solvent is used. If an unlisted residual solvent is to be determined. If a non-established Head-Space-GC solvent is being investigated. If a method that has not been described is to be used.
If a class-3 solvent is to be analysed with the described GC methods, because determination using loss on drying is either not possible or is not permitted. What are the arguments for method development and a product-specific validation of methods? The methods are reliable as they have been matrix-specific validated. The methods are optimised for the product and the analysis.
There are cost savings due to regular receipt of samples and often lower limits of determination from the optimised methods. Do you need further information? Fachartikel zum Thema Paper: Related topics Company profile: Our services in detail:
Residual solvents in pharmaceutical products are defined as organic volatile compounds. Residual solvents are necessary to ameliorate the. Quality Control in Pharmaceuticals: Residual Solvents Testing and Analysis. Changqin Hu and Ying Liu. National Institutes for Food and Drug. Parent Guideline: Impurities: Guideline for Residual Solvents. Q3C. Approval by .. Therefore, testing should be performed for residual solvents.