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ISSN 2063-5346
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DEVELOPMENT AND VALIDATION OF EDC RESIDUAL SOLVENT DETERMINATIONBY HEADSPACE GAS CHROMATOGRAPHY IN SAMPLE(ACTIVE PHARMACEUTICAL INGREDIENT, INTERMEDIATE AND KEY RAW MATERIAL)

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Surendra chourasiya1*, Dr.Rashmi Shrivastwa
» doi: 10.48047/ecb/2023.12.si5a.050

Abstract

Solvents are widely used during the manufacturing, purification and processing of pharmaceutical substances. The residues of these solvents must be removed to the extent possible, as they do not have any therapeutic effect but can cause undesirable effects in theconsumers. These solvent residues concentration should not exceed the limits prescribed in the ICH guidelines. This present review work is emphasized on various techniques are being used to The determination of residual solvents with their merits and demerits.An accurate, precise,linear and sensitive method was developed for residual solvents determination by fast static headspace gas chromatography (HSGC) with flame ionization detector in Sample. Residual solvents in drug substances are quantified using gas chromatography with headspace. As per regulatory guidelines, residual solvents must be controlled for release This paper includes the development and validation of HSGC method for the determination of residual solvents specifically EDC content in Sample. DB-624 capillary column, 30 m long × 0.53 mm internal diameter, the 3 μm film thickness was used for analysis with FID detector. The method can be readily used

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