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    USP Class 2 Residual Solvents List Class 1 Residual Solvents List

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    kirandas_mullassery
    The document contains two lists of residual solvents: 1. Class 1 Residual Solvents List which provides concentration limits in parts per million (PPM) for various solvents. 2. USP Class 2 Residual Solvents List which provides permissible daily exposure (PDE) limits in milligrams per day for various solvents. It also notes that no toxicological data was found to set PDE limits for some additional solvents. The document provides information on concentration and exposure limits for residual solvents.

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    USP Class 2 Residual Solvents List Class 1 Residual Solvents List

    Uploaded by

    kirandas_mullassery
    736 views2 pages
    The document contains two lists of residual solvents: 1. Class 1 Residual Solvents List which provides concentration limits in parts per million (PPM) for various solvents. 2. USP Class 2 Residual Solvents List which provides permissible daily exposure (PDE) limits in milligrams per day for various solvents. It also notes that no toxicological data was found to set PDE limits for some additional solvents. The document provides information on concentration and exposure limits for residual solvents.

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    Class of solvents.xlsxdsafcds

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    The document contains two lists of residual solvents: 1. Class 1 Residual Solvents List which provides concentration limits in parts per million (PPM) for various solvents. 2. USP Class 2 Residual Solvents List which provides permissible daily exposure (PDE) limits in milligrams per day for various solvents. It also notes that no toxicological data was found to set PDE limits for some additional solvents. The document provides information on concentration and exposure limits for residual solvents.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as XLSX, PDF, TXT or read online from Scribd
    Download as xlsx, pdf, or txt
    736 views2 pages

    USP Class 2 Residual Solvents List Class 1 Residual Solvents List

    Uploaded by

    kirandas_mullassery
    The document contains two lists of residual solvents: 1. Class 1 Residual Solvents List which provides concentration limits in parts per million (PPM) for various solvents. 2. USP Class 2 Residual Solvents List which provides permissible daily exposure (PDE) limits in milligrams per day for various solvents. It also notes that no toxicological data was found to set PDE limits for some additional solvents. The document provides information on concentration and exposure limits for residual solvents.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as XLSX, PDF, TXT or read online from Scribd
    Download as xlsx, pdf, or txt
    of 2

    Class 1 Residual Solvents List

    SOLVENT CONCENTRATION LIMIT (PPM) 2 4 5 8 1500

    USP Class 2 Residual Solvents List


    SOLVENT PDE (MG/DAY)

    Benzene Carbon tetrachloride 1,2-Dichloroethane 1,1-Dichloroethene 1,1,1-Trichloroethane

    Acetonitrile Chlorobenzene Chloroform Cyclohexane 1,2-Dichloroethene 1,2-Dimethoxyethane N,N-Dimethylacetamide N,N-Dimethylformamide 1,4-Dioxane 2-Ethoxyethanol

    4.1 3.6 0.6 38.8 18.7 1 10.9 8.8 3.8 1.6 6.2 2.2 2.9 30 0.5 0.5 11.8 6 5.3 0.5 2 1.6 7.2 1 8.9 0.8 21.7

    he residual solvents listed below may be of interest to manufacturers of drug substances, excipients, or drug products. However, no adequate toxicological data on which to base a PDE was found.
    1,1-Diethoxypropane 1,1-Dimethoxymethane 2,2-Dimethoxypropane Isooctane Isopropyl ether Methylisopropyl ketone Methyltetrahydrofuran Petroleum ether Trichloroacetic acid Trifluoroacetic acid

    Ethylene glycol Formamide Hexane Methanol 2-Methoxyethanol Methylbutylketone Methylcyclohexane Methylene chloride N-Methylpyrrolidone Nitromethane Pyridine Sulfolane Tetrahydrofuran Tetralin Toluene Trichloroethylene Xylene*

    * Usually 60% m-xylene, 14% p-xylene, 9% o-xylene with 17% ethyl benzene

    Solvents List
    CONCENTR ATION LIMIT (PPM) 410 360 60 3880 1870 100 1090 880 380 160 620 220 290 3000 50 50 1180 600 530 50 200 160 720 100 890 80 2170

    USP Class 3 Residual Solvents List

    Acetic acid Acetone Anisole 1-Butanol 2-Butanol Butyl acetate tert-Butylmethyl ether Cumene Dimethyl sulfoxide Ethanol Ethyl acetate Ethyl ether Ethyl formate Formic acid

    Heptane Isobutyl acetate Isopropyl acetate Methyl acetate 3-Methyl-1-butanol Methylethylketone Methylisobutylketone 2-Methyl-l-propanol Pentane 1-Pentanol 1-Propanol 2-Propanol Propyl acetate

    e, 9% o-xylene with 17% e

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