Description

Bisacodyl Related Compound E (20 Mg) (2-[(4-Acetoxyphenyl)(Pyridin-2-Yl)Methyl]Phenyl Acetate) is a high-purity analytical reference standard, a key impurity and degradation product of the active pharmaceutical ingredient Bisacodyl. This compound is critical for ensuring the quality, safety, and efficacy of pharmaceutical formulations through precise analytical control. It is primarily required by pharmaceutical R&D laboratories, quality control (QC) departments, and contract research organizations (CROs) for method development, validation, and routine impurity profiling.

Application

• Pharmaceutical Impurity Standard: Serves as a certified reference material (CRM) for the identification and quantification of impurities in Bisacodyl drug substances and finished dosage forms (tablets, suppositories).
• Analytical Method Development & Validation: Used as a critical system suitability component in HPLC, UPLC, and GC methods to establish specificity, accuracy, and detection limits.
• Stability Studies: Employed to monitor the formation of degradation products under various stress conditions (heat, light, humidity) as per ICH guidelines.
• Pharmacopoeial Compliance: Essential for testing to meet stringent pharmacopoeial standards (USP, EP, BP) for related substances in Bisacodyl.
• Regulatory Submissions: Provides necessary data on impurity profiles for regulatory filings (e.g., ANDA, NDA) with agencies like the FDA and EMA.
• Quality Control & Batch Release: Acts as a primary standard in routine QC testing to ensure every batch of API or drug product meets pre-defined purity specifications.

Basic Information

Product Name	Bisacodyl Related Compound E (20 Mg) (2-[(4-Acetoxyphenyl)(Pyridin-2-Yl)Methyl]Phenyl Acetate)
CAS No.	111664-35-8
Molecular Formula	C23H19NO4
Molecular Weight	373.40 g/mol
Synonyms	2-[(4-Acetoxyphenyl)(2-Pyridinyl)Methyl]Phenyl Acetate; Bisacodyl Impurity E; Bisacodyl Related Substance E; 1,2-Bis(4-acetoxyphenyl)-2-(pyridin-2-yl)ethan-1-one (tautomeric form); Bisacodyl Degradation Product; 2-Pyridinyldiphenylmethane-4,4'-diyl diacetate; 4,4'-(Pyridin-2-ylmethylene)bis(phenyl acetate); Contact for details on additional aliases.
EINECS	Contact for details

Quality Control

Every batch of Bisacodyl Related Compound E is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic (HPLC, UPLC) and spectroscopic (NMR, MS) techniques to ensure it meets the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each unit, detailing batch-specific results. Our quality commitment aligns with cGMP principles for active pharmaceutical ingredients (APIs) and excipients.

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 material is hygroscopic (moisture-sensitive); ensure the container is kept tightly sealed in a low-humidity environment to prevent degradation. For long-term stability, consider storage under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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