Description

Desacetyl Bisacodyl β-D-Glucuronide is a key metabolite and reference standard of the laxative drug bisacodyl. This compound matters significantly for pharmaceutical research and development, particularly in the study of drug metabolism, pharmacokinetics, and the development of analytical methods. It is primarily needed by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories involved in bioanalytical method validation, impurity profiling, and ensuring drug safety and efficacy.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of bisacodyl metabolites in biological matrices during clinical and non-clinical studies.
• Metabolite Research: Critical for investigating the metabolic pathways, bioavailability, and excretion profile of bisacodyl in pharmacokinetic and ADME (Absorption, Distribution, Metabolism, Excretion) studies.
• Bioanalytical Method Development: Serves as a primary standard for calibrating HPLC, LC-MS, and LC-MS/MS systems to develop and validate sensitive assays for drug and metabolite levels in plasma, urine, and feces.
• Impurity Profiling: Employed in the identification and control of potential process-related impurities and degradation products in bisacodyl drug substance and finished dosage forms.
• Toxicology Studies: Used to understand the safety profile and potential toxicological implications of bisacodyl's major metabolites.
• Regulatory Submissions: Provides essential data to support regulatory filings (e.g., with FDA, EMA) by characterizing the drug's metabolic fate.

Basic Information

Product Name	Desacetyl Bisacodyl β-D-Glucuronide
CAS No.	31050-47-2
Molecular Formula	C28H32O10
Molecular Weight	528.55 g/mol
Synonyms	4,4'-(Pyridin-2-ylmethylene)diphenyl di-β-D-glucopyranosiduronic acid; Bisacodyl 4'-O-β-D-Glucuronide; Desacetylbisacodyl Glucuronide; 2-[4-(4-β-D-Glucopyranuronosyloxy)phenylmethyl]phenyl β-D-glucopyranosiduronic acid; Bisacodyl Glucuronide Metabolite; Bisacodyl Mono-Glucuronide; TP 21 Metabolite
EINECS	Contact for details

Quality Control

Our Desacetyl Bisacodyl β-D-Glucuronide is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity, LC-MS for identity confirmation, and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are provided for traceability and compliance.

Storage

Preserve in a 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) and must be kept in a desiccated environment to maintain stability and purity. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 2.0%
Residual Solvents (GC)	Complies with ICH guidelines

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