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    Home > Active Ingredient News > Drugs Articles > Scope of application of pharmaceutical grade propylene glycol solvent content CAS57-55-6 quality standard

    Scope of application of pharmaceutical grade propylene glycol solvent content CAS57-55-6 quality standard

    • Last Update: 2022-08-20
    • Source: Internet
    • Author: User
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    Chinese name 1,2-Propanediol English name 1,2-Propanediol alias Methylethylene glycol propylene glycol 1,2-dihydroxypropane English alias Propane-1,2-diolPropylene GlycolCAS57-55-6123120-98-9EINECS200-338-0 Chemical formula C3H8O2 Molecular weight 76.
    09InChIInChI: 1S/C3H8O2/c1-3(5)2-4/h3-5H, 2H2, 1H3 Melting point -60°C Boiling point 195.
    1°C at 760 mmHg Flash point 85.
    7°C Water-soluble miscible Vapor pressure 0.
    111mmHg Physical and chemical properties at 25°C Colorless, viscous and stable water-absorbing liquid, almost tasteless and odorless
    .

    Melting point -60℃ Boiling point 187.
    3℃ Relative density 1.
    0381 Refractive index 1.
    4326 Flash point 99℃ Solubility Miscible with water, ethanol and various organic solvents
    .

    The product is used as the raw material of resin, plasticizer, surfactant, emulsifier and demulsifier, and can also be used as antifreeze and heat carrier.
    3 drops of bromothymol blue indicator solution were titrated with sodium hydroxide titration solution (0.
    01mol/L) until the solution was blue, and the volume of sodium hydroxide titration solution (0.
    01mol/L) consumed should not exceed 0.
    5ml
    .

    Take 1.
    0ml of this product for oxide and check it according to the law (general rule 0801).
    Compared with the control solution made of 7.
    0ml of standard sodium oxide solution, it should not be deeper (0-007%)
    .

    Take 5.
    0ml of this product for sulfate, check according to the law (general rule 0802), compare with the reference solution made of 3.
    0ml of standard potassium sulfate solution, no deeper (0.
    006%) oxidizing substances take 5.
    0ml of this product, put it in In an iodine volumetric flask, add 1.
    5 ml of potassium iodide test solution and 2 ml of dilute sulfuric acid, seal it tightly, place it in the dark for 15 minutes, add 2 ml of starch indicator solution, if it turns blue, use sodium thiosulfate titration solution (0.
    005mol 2mL 。 /L) titrated until the blue disappears, the consumption of sodium thiosulfate titration solution (0.
    005mol/L) volume should not exceed 0.
    2mL
    .

    Take 1.
    0 ml of this product for reducing substances, add 1 ml of ammonia test solution, and heat it in a 60flC bath for 5 minutes, the solution should not show yellow; quickly add 0.
    15 ml of silver nitrate test solution, shake well, and leave for 5 minutes, the solution should be free of change
    .

    Take the appropriate amount of this product for related substances, accurately weigh it, and dilute it with absolute ethanol to make a solution containing 0.
    5 g of propylene glycol in every lpil, as the test solution; Take an appropriate amount of this product for moisture, and measure it according to the moisture determination method (general rule 0832 first method 1), and the moisture content should not exceed 0.
    2%
    .

    Take 50g of this product from the residue on ignition, heat it to combustion, stop heating, and make natural combustion to 1,000 , at 700 ~ 800aC, burn to constant weight, and the remaining residue should not exceed 2.
    5mg
    .

    Take 4.
    0ml of this product for heavy metals, add 19ml of water and 2ml of acetate buffer (pH 3.
    5), mix well, Check according to the law (the first method of general rule 0821), the heavy metal content should not exceed 5 parts per million
    .

    Take 1.
    0 g of this product for arsenic salt, add 5ml of hydrochloric acid and 23ml of water, shake well, check according to law (general rule 0822), it should be Comply with the regulations (0.
    0002%)
    .

    Propylene glycol - content determination according to gas chromatography (general rule 0521)
    .

    Chromatographic conditions and system suitability test take polyethylene glycol 20M as the stationary phase; the initial temperature is 130°C, maintained for 1 minute, and is heated to 240°C at a rate of 10°C per minute, maintained for 1 minute, and then continued.
    The temperature of the sample port is 230 ° C, and the temperature of the detector is 250 ° C.
    The number
    of
    theoretical plates is not less than 10 000 according to the peak of 1,2-propanediol
    .

    The measurement method takes this product, accurately weighs it, and dilutes it with anhydrous ethanol to make each About the solution containing 1 g in 1 l, accurately measure lpl and inject into gas chromatograph, record the chromatogram; take another 1,2-propanediol reference substance, measure with the same method, calculate with peak area by external standard method, to obtain final product
    .

    Propylene Glycol - class of pharmaceutical excipients, solvents and plasticizers, etc.

    Propylene
    Glycol - Store tightly sealed in a dry place away from light
    .

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