Transcription of ANALYTICAL METHODS FOR RESIDUAL SOLVENTS …
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ANALYTICAL METHODS FOR RESIDUAL SOLVENTS …
Acta Poloniae Pharmaceutica Drug Research, Vol. 67 No. 1 pp. 13 26, 2010 ISSN 0001-6837 Polish Pharmaceutical SocietyOrganic SOLVENTS are routinely applied duringsynthesis of drug substances, excipients, or duringdrug product formulation. They are not desirable inthe final product, mainly because of their toxicity,their influence on the quality of crystals of the drugsubstance and their odor or taste, which can beunpleasant for patients. To remove them, variousmanufacturing processes or techniques (usually underincreased temperature or/and decreased pressure) arein use. Even after such processes, some SOLVENTS stillremain, yet in small quantities. These small quantitiesof organic SOLVENTS are commonly known as organicvolatile impurities (OVIs) or RESIDUAL SOLVENTS (RS).The need to test and control for RS in pharma-ceutical products was recognized in late 70 s.
Analytical methods for residual solvents determination... 15 GC methods GC is a natural choice, as means for RS deter-mination, as organic solvents have relatively low
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