Description

Bisacodyl Related Compound C (20 Mg) (4-[(4-Hydroxyphenyl)(Pyridin-2-Yl)Methyl]Phenyl Acetate) is a high-purity analytical reference standard, essential for pharmaceutical research and quality control. This compound, with CAS No. 72901-16-7, serves as a critical impurity marker and system suitability standard in the analysis of the active pharmaceutical ingredient Bisacodyl. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure drug purity, safety, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material (CRM) for the identification and quantification of related substances in Bisacodyl drug substance and finished dosage forms.
• Analytical Method Development & Validation: A critical component for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods according to ICH Q2(R1) guidelines.
• Quality Control (QC) Testing: Employed as a system suitability standard in routine QC laboratories to ensure the analytical system is performing correctly for the assay of Bisacodyl.
• Stability Studies: Used to monitor the formation of degradation products in Bisacodyl formulations under various stress conditions (e.g., heat, humidity, light).
• Regulatory Compliance & Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive impurity characterization data required for drug master files (DMFs) and new drug applications (NDAs).
• Pharmacopeial Testing: Essential for compliance testing against monographs in the United States Pharmacopeia (USP), European Pharmacopoeia (Ph. Eur.), or other international pharmacopeias.

Basic Information

Product Name	Bisacodyl Related Compound C (20 Mg) (4-[(4-Hydroxyphenyl)(Pyridin-2-Yl)Methyl]Phenyl Acetate)
CAS No.	72901-16-7
Molecular Formula	C20H17NO3
Molecular Weight	319.36 g/mol
Synonyms	4-[(4-Hydroxyphenyl)(2-Pyridinyl)Methyl]Phenyl Acetate; Bisacodyl Impurity C; 4'-(Acetyloxy)-4-[(2-pyridinyl)(4-hydroxyphenyl)methyl]phenyl ester; Bisacodyl Related Substance C; 4-[(4-Hydroxyphenyl)(pyridin-2-yl)methyl]phenyl acetate; 2-Pyridyl(4'-hydroxy-4-acetoxy)diphenylmethane; Bisacodyl EP Impurity C
EINECS	Contact for details

Quality Control

Every batch of our Bisacodyl Related Compound C is manufactured and tested under strict quality management systems. The product undergoes rigorous analytical characterization, including HPLC purity assay, identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting compliance with cGMP and relevant pharmacopeial guidelines (USP, Ph. Eur.).

Storage

Preserve in the original, tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive); ensure the container is kept tightly sealed in a low-humidity environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.