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Correspondence to Author: Arya Priyanka, 

M.S.Regulatory Toxicology, DABT.

Abstract:

The manufacture and use of drugs and chemicals have brought numerous benefits to modern society. However, unintended exposure to these chemicals in the final drug formulation can cause a significant health hazard to the Patients and unintended exposure to these agents at the manufacturing workplace can cause a significant health hazard to the workers at the manufacturing plant. Residual Solvants in Pharmaceuticals are defined as organic volatile chemicals that are used or produced in the manufacturing of the drug substance or excipients, or in the preparation of drug products. The aim of the current publication is to determine the Permitted daily Exposure (PDE) and Occupational Exposure Limit (OEL) of 2-Chloropropane, which is a commonly used solvent in Pharmaceutical industry. The following Regulatory Guidelines were followed while deriving the PDE value for 2-chloropropane, ICH Q3C, ICH Q3D, EMA/ CHMP/CVMP/SWP/169430/2012. A Literature Review was conducted to identify toxicity studies of 2-Chloropropane. Hazard and sensitive endpoints were determined. Based on the No Observed Adverse Effect Level/Concentration (NOAEL/NOAEC) and Lowest Observed Adverse Effect Level/ Concentration (NOAEC) reported from battery of toxicology studies like repeat dose, reproductive and development toxicity studies, the PDE value and OEL value was calculated.

Keywords:Permitted Daily Exposure, Occupational Exposure Limit, 2-Chloropropane, Residual Solvant, Cleaning Validation, Multipurpose/Shared Manufacturing Facility, Cross Contamination.

Citation:

Arya Priyanka. Permitted Daily Exposure for 2-Chloropropane as a Residual Solvent in Pharmaceuticals. Journal of Toxicological Research 2024.