Description

Bisacodyl Impurity 1 CAS NO 13004-51-8 is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient (API) Bisacodyl, a widely used stimulant laxative. It is an essential tool for researchers and quality assurance professionals in the pharmaceutical and fine chemical industries who require precise impurity profiling and method validation. The availability of a well-characterized impurity standard is fundamental for meeting stringent pharmacopeial requirements and maintaining supply chain integrity.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material to identify, quantify, and monitor Bisacodyl Impurity 1 during API synthesis and in finished drug products.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, and GC methods for purity and stability testing.
• Quality Control and Assurance (QC/QA): Employed in routine quality control laboratories to establish specification limits and ensure batch-to-batch consistency of Bisacodyl API.
• Stability Studies: Used to track the formation of this specific impurity under various stress conditions (heat, light, humidity) to determine drug product shelf life.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research and Development: Facilitates process chemistry research aimed at minimizing or eliminating this impurity during the synthesis of Bisacodyl.

Basic Information

Product Name	Bisacodyl Impurity 1
CAS No.	13004-51-8
Molecular Formula	C22H19NO4
Molecular Weight	361.39 g/mol
Synonyms	4,4'-(2-Pyridinylmethylene)bis(phenol) diacetate; Bisacodyl Impurity A; 4-[Hydroxy(2-pyridinyl)methyl]phenyl acetate; 4,4'-(Pyridin-2-ylmethylene)diphenol diacetate; 2-[(4-Acetoxyphenyl)(4-hydroxyphenyl)methyl]pyridine; A related compound of Bisacodyl; Bisacodyl Related Compound A
EINECS	Contact for details

Quality Control

Our Bisacodyl Impurity 1 is manufactured under strict quality systems to ensure it meets the exacting standards required for pharmaceutical reference materials. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) that includes data from orthogonal analytical techniques such as HPLC, NMR, and Mass Spectrometry. We ensure compliance with relevant guidelines for impurity standards. Certificates of Analysis (COA) are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material 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 structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5% w/w

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