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    Amiloxate

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    Rizal Ibeel
    Amiloxate is an active pharmaceutical ingredient that must contain 95-105% of C15H20O3. It should be stored in tight containers. The document provides specifications for identification, specific gravity, refractive index, acidity, chromatographic purity, and assay of Amiloxate. The assay involves using gas chromatography to analyze Amiloxate samples and a USP reference standard, and calculates the quantity of Amiloxate based on peak responses.

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    Amiloxate

    Uploaded by

    Rizal Ibeel
    80 views2 pages
    Amiloxate is an active pharmaceutical ingredient that must contain 95-105% of C15H20O3. It should be stored in tight containers. The document provides specifications for identification, specific gravity, refractive index, acidity, chromatographic purity, and assay of Amiloxate. The assay involves using gas chromatography to analyze Amiloxate samples and a USP reference standard, and calculates the quantity of Amiloxate based on peak responses.

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    Amiloxate is an active pharmaceutical ingredient that must contain 95-105% of C15H20O3. It should be stored in tight containers. The document provides specifications for identification, specific gravity, refractive index, acidity, chromatographic purity, and assay of Amiloxate. The assay involves using gas chromatography to analyze Amiloxate samples and a USP reference standard, and calculates the quantity of Amiloxate based on peak responses.

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    © All Rights Reserved
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    Download as docx, pdf, or txt
    80 views2 pages

    Amiloxate

    Uploaded by

    Rizal Ibeel
    Amiloxate is an active pharmaceutical ingredient that must contain 95-105% of C15H20O3. It should be stored in tight containers. The document provides specifications for identification, specific gravity, refractive index, acidity, chromatographic purity, and assay of Amiloxate. The assay involves using gas chromatography to analyze Amiloxate samples and a USP reference standard, and calculates the quantity of Amiloxate based on peak responses.

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    Amiloxate contains not less than 95.0 percent and not more than 105.0 percent of C15H20O3.

    Packaging and storage- preserve in thight containers.


    USP Reference standars (11)- USP Amiloxate RS.
    IdentificationA: infrared absorption
    B: ultraviolet Absorption
    Solution: 5.0 g per mL
    Medium: alcohol
    Absorptivities, calculated on the as-is basis, do not differ by more than 3.0%.
    Specific gravity (841): between 1.037 and 1.041
    Refractive index (831): between 1.556 and 1.560 at 200.
    Acidity- transfer 50 mL of alcohol to a suitable container, add 1 mL of phenolpthalein TS, and add
    sufficient 0,1 N sodium hydroxide to obtain a persistent pink color. Transfer 50 mL of this solution to
    a suitable container, add about 5.0 mL of amiloxate, accurately measured ,mix, and titrate with 0,1 N
    sodium hydroxide: bot more than 0,2 mL of titrant per mL of amiloxate is required for neutralization.
    Chromatograpic purityTest solution- use the assay preparation.
    Chromatograpic system- proceed as directed in the assay. To evaluate the system suitability
    requirements, use the standard preparation prepared as directed in the assay.
    Prcedure- inject a volume (about 1 L) of the test solution into the chromatograph, reord
    the chromatogram, and measure all of the peak response. Calculate the percentage of each impurity
    in the portion of amoxilate taken by the formula:
    100(ri / rs)
    In wich ri is the peak response for each impurity; and rs is the sum of the responses of all the peaks;
    not more than 0,1% of any individual impurity is found; and not more than 2.0% of total impurities is
    found.
    AssayStandard preparation- dissolve an accurately weighed quantity of USP amiloxate RS in terbutyl methyl ether, and dilute quantitively, and stepwise if necessary, with ter-buthyl methyl ether
    to obtain a solution having a known concentration of about 20.0 mg per mL.
    Assay preparation- transfer about 2.0 g of amiloxate, accurately weighed, to a 100-mL
    volumetric flask, dilute with acetone to volume, and mix.
    Chromatographic system (see chromatography (621)- the gas chromatograph is equipped
    with flame-ionization detector and a 0.32 mm x 25 mm column coated with a 0.1 m film of Gi. The
    carrier gas is helium, flowing at a arate of about 6 mL per minute. The chromatograph is
    programmed as follows. Initially the temperature of the column is equilbrated at 60o, then the

    temperature is incrased at a rate of 8o per minute to 240o and maintained at 240o ror 10 minutes.
    The injection port temperature is maintained at 240o, and the detector temperature is maintened at
    260o. Chromatograph the standard preparation, and record the peak responces and direct for
    procedure; the resolution, R, between the amiloxate peak and any other peak is not less than 1.0;
    and the realtive standard deviation for replicate injections is not more than 2.0%.
    Procedure-separately inject equal volumes (about 1 L) of the standard preparation and the
    assay preparation into the chromatograph, record the chromatograms, and measure the responses
    for the major peaks. Calculate the quantity in mg, of C15H20O3 in the position of amiloxate taken by
    the formula:
    100(ru/ rs)
    In wich C is the concentration, in mg per mL, of USP amiloxate RS in the standard preparation; and ru
    and rs are the peak responses obtained from the assay preparation and the standard preparation,
    respectively.

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