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    GUID - 1 en-US

    Uploaded by

    Dilawar Bakht

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd

    GUID - 1 en-US

    Uploaded by

    Dilawar Bakht
    20 views2 pages

    Original Title

    GUID-D2CCF1B7-6AB0-4EED-86B3-2681E5435860_1_en-US

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    20 views2 pages

    GUID - 1 en-US

    Uploaded by

    Dilawar Bakht

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 2

    Printed on: Wed Jan 18 2023, 02:21:05 AM(EST) Status: Currently Official on 18-Jan-2023 DocId: GUID-D2CCF1B7-6AB0-4EED-86B3-2681E5435860_1_en-US

    Printed by: Rock Pharma Official Date: Official as of 01-May-2015 Document Type: NF @2023 USPC
    Do Not Distribute DOI Ref: mpb1j DOI: https://doi.org/10.31003/USPNF_M968_01_01
    1

    System suitability
    Hydrogenated Lanolin Samples: Standard solution A, Standard solution B, Standard
    CAS RN®: 8031-44-5. solution C, and Standard solution D
    [NOTE—See Table 2 for relative retention times.]
    DEFINITION
    A mixture of higher aliphatic alcohols, hydrocarbons, and Table 2
    sterols is obtained from the direct high-pressure, Relative
    high-temperature hydrogenation of lanolin. During the Retention
    hydrogenation process, the esters and acids present are Component Time
    reduced to the corresponding alcohols. Alcoholic derivatives Cetyl alcohol 1.00
    may be further reduced to hydrocarbons. It may contain
    antioxidants. Stearyl alcohol 1.15

    IDENTIFICATION Cholestane 1.63


    • A. Cholestanol 1.77
    Sample: 50 mg
    24,25-Dihydrolanosterol 1.85
    Analysis: Dissolve the Sample in 5 mL of methylene chloride,
    and add 1 mL of acetic anhydride and 0.1 mL of
    sulfuric acid. System suitability requirements
    Acceptance criteria: A green color is produced. Resolution: NLT 30 between cetyl alcohol and stearyl
    • B. CHROMATOGRAPHIC IDENTITY alcohol, Standard solution A
    Analysis: Proceed as directed in the test for Chromatographic Analysis
    Profile of Fatty Alcohols, Hydrocarbons, and Sterols in the Samples: Standard solution A, Standard solution B, Standard

    al
    Assay. solution C, Standard solution D, and Sample solution
    Acceptance criteria: The retention times of the cetyl Identify the peaks from Standard solution A, Standard
    alcohol, stearyl alcohol, cholestane, cholestanol, and solution B, Standard solution C, and Standard solution D.
    24,25-dihydrolanosterol peaks of the Sample solution Calculate the percentage of cetyl alcohol (stearyl alcohol,
    correspond to those of Standard solution A, as obtained in ci cholestane, cholestanol, or 24,25-dihydrolanosterol) in
    the Assay. the portion of Hydrogenated Lanolin taken:
    ASSAY Result = (rU/rS) × (CS/CU) × 100
    • CHROMATOGRAPHIC PROFILE OF FATTY ALCOHOLS,
    HYDROCARBONS, AND STEROLS rU = peak response of cetyl alcohol (stearyl alcohol,
    Standard solution A: 2.5 mg/mL of USP Hydrogenated cholestane, cholestanol, or
    ffi
    Lanolin RS in dehydrated alcohol 24,25-dihydrolanosterol) from the Sample
    Standard solution B: 0.5 mg/mL of cholestane, 0.5 mg/mL solution
    of cholestanol, and 0.25 mg/mL of 24,25-dihydrolanosterol rS = peak response of cetyl alcohol (stearyl alcohol,
    in dehydrated alcohol cholestane, cholestanol, or
    Standard solution C: 0.5 mg/mL of USP Cetyl Alcohol RS in 24,25-dihydrolanosterol) from Standard solution
    dehydrated alcohol. [NOTE—Vortex or sonification helps C, Standard solution D, or Standard solution B
    O

    standard preparation.] CS = concentration of USP Cetyl Alcohol RS (USP


    Standard solution D: 0.5 mg/mL of USP Stearyl Alcohol RS Stearyl Alcohol RS, cholestane, cholestanol, or
    in dehydrated alcohol. [NOTE—Vortex or sonification helps 24,25-dihydrolanosterol) in Standard solution C,
    standard preparation.] Standard solution D, or Standard solution B
    Sample solution: 2.5 mg/mL of Hydrogenated Lanolin in (mg/mL)
    dehydrated alcohol CU = concentration of Hydrogenated Lanolin in the
    Chromatographic system Sample solution (mg/mL)
    (See Chromatography á621ñ, System Suitability.)
    Mode: GC Acceptance criteria
    Detector: Flame ionization Sample solution: Chromatogram exhibits a profile similar
    Column: 0.25-mm × 30-m fused-silica capillary; 0.25-µm to that in the chromatogram of Standard solution A.
    layer of phase G2 Cetyl alcohol, stearyl alcohol, cholestane, cholestanol,
    Temperatures and 24,25-dihydrolanosterol: See Table 3.
    Detector: 350°
    Injection port: 325° Table 3
    Column: See Table 1. Acceptance
    Name Criteria (%)
    Table 1
    Cetyl alcohol 2–15
    Hold Time
    Initial Temperature Final at Final Stearyl alcohol 0.5–10
    Temperature Ramp Temperature Temperature
    (°) (°/min) (°) (min) Cholestane 2–13

    100 — 100 5 Cholestanol 3–11

    100 5 300 15 24,25-Dihydrolanosterol 3–15

    Carrier gas: Helium IMPURITIES


    Flow rate: 1 mL/min • RESIDUE ON IGNITION á281ñ: NMT 0.1%, determined on
    Injection volume: 1 µL 5.0 g

    https://online.uspnf.com/uspnf/document/1_GUID-D2CCF1B7-6AB0-4EED-86B3-2681E5435860_1_en-US 1/2
    Printed on: Wed Jan 18 2023, 02:21:05 AM(EST) Status: Currently Official on 18-Jan-2023 DocId: GUID-D2CCF1B7-6AB0-4EED-86B3-2681E5435860_1_en-US
    Printed by: Rock Pharma Official Date: Official as of 01-May-2015 Document Type: NF @2023 USPC
    Do Not Distribute DOI Ref: mpb1j DOI: https://doi.org/10.31003/USPNF_M968_01_01
    2

    SPECIFIC TESTS Acceptance criteria: NMT 3.0%


    • MELTING RANGE OR TEMPERATURE á741ñ: 45°–55°. Allow to
    stand at 20° for 16 h. ADDITIONAL REQUIREMENTS
    • FATS AND FIXED OILS, Acid Value á401ñ: NMT 1.0, • PACKAGING AND STORAGE: Preserve in well-closed
    determined on 5.0 g containers, protected from light. Do not store above 45°.
    • FATS AND FIXED OILS, Hydroxyl Value á401ñ: 140–180 • LABELING: Label it to indicate the name and amount of the
    • FATS AND FIXED OILS, Saponification Value á401ñ: NMT 8.0. antioxidant added.
    Heat under reflux for 4 h. • USP REFERENCE STANDARDS á11ñ
    • LOSS ON DRYING á731ñ USP Cetyl Alcohol RS
    Sample: 2.0 g USP Hydrogenated Lanolin RS
    Analysis: Dry the Sample in an oven at 105° for 1 h. USP Stearyl Alcohol RS

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    https://online.uspnf.com/uspnf/document/1_GUID-D2CCF1B7-6AB0-4EED-86B3-2681E5435860_1_en-US 2/2

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