Description

Bisacodyl Related Compound B (20 Mg) (2,4'-(Pyridin-2-Ylmethylene)Diphenol) is a high-purity chemical reference standard, specifically a process-related impurity 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 manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality assurance testing. The product is supplied as a 20 mg unit, ideal for precise laboratory use.

Application

• Pharmaceutical Impurity Profiling and Control: Serves as a certified reference material for the identification and quantification of related substances in Bisacodyl drug substance and finished dosage forms according to ICH Q3A/B guidelines.
• Analytical Method Development and Validation: Used as a system suitability standard and for establishing detection/quantification limits in HPLC, UPLC, and LC-MS methods.
• Stability Studies: Employed to monitor the formation of degradation products in Bisacodyl formulations under various stress conditions (e.g., heat, light, humidity).
• Regulatory Compliance and Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Quality Control Laboratory Testing: Used in routine batch release testing to ensure drug products meet stringent pharmacopeial (USP, EP) specifications for purity.
• Research and Development: Utilized in synthetic chemistry R&D to study the pathways of impurity formation and to develop purification processes.

Basic Information

Product Name	Bisacodyl Related Compound B (20 Mg) (2,4'-(Pyridin-2-Ylmethylene)Diphenol)
CAS No.	16985-05-0
Molecular Formula	C₁₉H₁₅NO₂
Molecular Weight	289.33 g/mol
Synonyms	2,4'-(Pyridin-2-Ylmethylene)Diphenol; 2,4'-[(2-Pyridinyl)methylene]bisphenol; 2,2'-Dihydroxy-5-[(pyridin-2-yl)methyl]diphenylmethane; Bisacodyl Impurity B; Bisacodyl Related Substance B; 2-[Bis(4-hydroxyphenyl)methyl]pyridine; 4,4'-(Pyridin-2-ylmethylen)diphenol
EINECS	Contact for details

Quality Control

Our Bisacodyl Related Compound B is manufactured and tested under strict quality management systems. Each batch undergoes comprehensive analytical characterization to ensure identity, purity, and consistency, meeting the stringent requirements for pharmaceutical reference standards. Certificates of Analysis (COA) are provided with each unit, detailing results from tests including Identification (IR, HPLC), Assay (HPLC), and related substance analysis. We support compliance with cGMP, ICH, USP, and EP guidelines.

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 light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

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

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