Bisacodyl USP

Bisacodyl USP, identified by the chemical name bisacodyl, is a pivotal active pharmaceutical ingredient (API) within pharmaceuticals and nutraceuticals. Its versatile applications extend to various drug delivery and care solutions, contributing to the diverse landscape of other drug and care solutions within the market.

Chemical Name: Bisacodyl

CAS Number: 603-50-9

Chemical Inventories: AICS (Australia), ECL (Korea), EINECS (EU), NDSL (Canada), PICCS (Phillipines), TCSI (Taiwan), TSCA (USA)

Certifications & Compliance: FDA 29 CFR 1910.1200, United States Pharmacopeia (USP)

    Enhanced TDS

    Identification & Functionality

    Chemical Name
    Bisacodyl
    Industry
    Over the Counter
    Pharma & Nutraceuticals Functions
    OTC
    Molecular formula
    C₂₂H₁₉NO₄
    Technologies
    Pharmaceuticals & Nutraceuticals
    Product Families
    Pharmaceuticals & Nutraceuticals — Pharmaceutical Actives & Precursors
    Active Pharmaceutical Ingredients (APIs)
    Definition

    Bisacodyl contains not less than 98.0% and not more than 102.0% of bisacodyl (C₂₂H₁₉NO₄), calculated on the dried basis.

    Molecular Structure

    Chemical Structure

    Bisacodyl Chemical Structure - 1

    Applications & Uses

    Markets
    Healthcare & Pharma
    Applications
    Healthcare & Pharma — Drug Delivery & Care Solutions
    Other Drug & Care Solutions
    Use Level
    0.996 mg of bisacodyl per mg of material on the as is basis

    Properties

    Physical Form
    Powder
    Soluble In
    Benzene Soluble,
    Chloroform Soluble,
    Propylene Glycol Soluble
    Typical Properties
    ValueUnitsTest Method / Conditions
    Molecular Weight361.39--
    Microbiological Values
    ValueUnitsTest Method / Conditions
    Bisacodyl (dried basis)98.0 - 102.0%-

    Regulatory & Compliance

    Certifications & Compliance
    FDA 29 CFR 1910.1200,
    United States Pharmacopeia (USP)
    Chemical Inventories
    AICS (Australia),
    ECL (Korea),
    EINECS (EU),
    NDSL (Canada),
    PICCS (Phillipines),
    TCSI (Taiwan),
    TSCA (USA)
    FDA Disclaimer

    These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

    USP Reference Standards
    • USP Bisacodyl RS USP Bisacodyl Related Compound A RS 4,4′-(Pyridin-2-ylmethylene)diphenol
    • C18H15NO2 277.32 USP Bisacodyl Related Compound B RS 2,4′-(Pyridin-2-ylmethylene)diphenol
    • C18H15NO2 277.32 USP Bisacodyl Related Compound C RS 4-[(4-Hydroxyphenyl)(pyridin-2-yl)methyl]phenyl acetate
    • C20H17NO3 319.35 USP Bisacodyl Related Compound E RS 2-[(4-Acetoxyphenyl)(pyridin-2-yl)methyl]phenyl acetate
    • C22H19NO4 361.39

    Technical Details & Test Data

    Assay Procedure

    ASSAY 

    PROCEDURE

    Buffer: 1.58 g/L of ammonium formate in water; adjusted with formic acid to a pH of 5.0

    Mobile phase: Acetonitrile and Buffer (45:55)

    Diluent: Acetonitrile, acetic acid, and water (30:4:66)

    Standard solution: 0.5 mg/mL of USP Bisacodyl RS in Diluent

    Sample solution: 0.5 mg/mL of Bisacodyl in Diluent

    Chromatographic system (See Chromatography (621), System Suitability.)

    Mode: LC Detector: UV 265 nm

    Column: 4.6-mm x 25-cm; 5-um packing L1

    Flow rate: 1.5 mL/min Injection volume: 10 pL

    Run time: NLT 2 times the retention time of bisacodyl

    System suitability

    Sample: Standard solution uitability requirement: ailing factor: NMT 1.5 Relative standard deviation: NMT 0.73%

    Analysis Samples: Standard solution and Sample solution Calculate the percentage of bisacodyl (C22H19NO4) in the portion of Bisacodyl taken:

    Result = (rur) × (C/Cu) × 100

    ru = peak response of bisacodyl from the Sample solution

    rs = peak response of bisacodyl from the Standard solution

    Cs = concentration of USP Bisacodyl RS in the Standard solution (mg/mL)

    Cu = concentration of Bisacodyl in the Sample solution (mg/mL)

    Acceptance criteria: 98.0%-102.0% on the dried basis