Dear Rishabh,
There are many processes and activities during manufacturing of a drug product where organic solvents are used in many different aspects. Sometimes, their usage improves product quality and is a necessary factor. Good selection of a solvent
may also be critical for a given process. However, in most cases their presence in a final product is undesirable and manufacturers have to employ safe and effective methods to remove them. New technologies in polymers production, replaced organic solvents usage in a film-coating process almost entirely. Also, in a wetñgranulation process, water is nowadays the most frequently used solvent and only during more complex formulations, when the API is sensitive to moisture or the process requires short time of drying, some organic solvents are involved. However, during an API synthesis, which is a complex process and requires different solvents, organic solvents cannot be easily replaced by water. Even with the use of modern equipment for drying, some amounts of organic solvents can still remain in the
final product. The acceptable limits for residual solvents are being published in pharmacopoeias and in ICH Guideline and analytical methods need to be sensitive enough for this task. Thanks to new technologies in many cases the organic solvents can be replaced by water, supercritical fluids, ionic liquids or other innovations. Still it worth underlining that the aim of drug production is to provide the medicine with an effective therapeutic function and minimize the acquirable risk for human health. It can be concluded from the above presentation that determination of trace organic solvents in pharmaceutical products appears as an important
task, for which the relevant analytical methods will be presented in the next paper.
This text was taken from the conclusion section of a review article entitled "ORGANIC SOLVENTS IN THE PHARMACEUTICAL INDUSTRY " by KATARZYNA GRODOWSKA1,2* and ANDRZEJ PARCZEWSKI. For more details, see attched review. For the solvents names used in the pharmaceutical industry please see Tables 1-3.
Hoping this will be helpful,
Rafik
as per pharmacopoeia solvent s have categorised to safe, toxic& severely toxic .and safe limits also have prescribed in API. . BEAWARE OF BENZENE it is totaly prohibited due to its carcinogenic nature
consult any pharmacopoeia before use any solvent in last stage of API
Dear Rishabh,
The above answers are really very informative. Please also keep in mind that, when you are using any of the organic solvents then it should also comply with the residual limit for it as given in the pharmacopoeia. As long as you comply with the residual limit of a particular organic solvent, you can easily use it in any of your formulation. Benzene and related solvents are not allowed due to their carcinogenic effect.
http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm073395.pdf
document on this link should be interesting
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