Description

n-Desmethyl Pirenzepine is a key metabolite and reference standard of the antimuscarinic drug pirenzepine, offering critical value for pharmaceutical research and development. This compound is essential for analytical method development, pharmacokinetic studies, and metabolic profiling, ensuring accurate quantification and understanding of the parent drug's behavior in biological systems. It is primarily utilized by pharmaceutical companies, contract research organizations (CROs), and academic institutions engaged in drug metabolism and safety (DMPK) studies, quality control laboratories, and the development of bioanalytical assays.

Application

• Pharmaceutical Reference Standard: Serves as a certified standard for the identification and quantification of pirenzepine and its metabolites in drug substance and product testing.
• Drug Metabolism and Pharmacokinetics (DMPK): Used as a critical metabolite in studies investigating the absorption, distribution, metabolism, and excretion (ADME) profile of pirenzepine.
• Bioanalytical Method Development: Essential for developing and validating sensitive HPLC, LC-MS, or GC-MS methods for therapeutic drug monitoring and clinical studies.
• Impurity Profiling: Employed to identify, characterize, and control potential degradation products and process-related impurities in active pharmaceutical ingredient (API) manufacturing.
• Pharmacological Research: Used in vitro and in vivo studies to understand the specific activity and role of this metabolite compared to the parent compound.
• Regulatory Submissions: Provides necessary data and reference materials for regulatory filings (e.g., with FDA, EMA) to support drug approval and quality documentation.

Basic Information

Product Name	n-Desmethyl Pirenzepine
CAS No.	63257-31-8
Molecular Formula	C₁₉H₂₁N₅O₂
Molecular Weight	351.41 g/mol
Synonyms	Pirenzepine N-Desmethyl Metabolite; 11-[(4-Methylpiperazin-1-yl)acetyl]-5H-dibenzo[b,e][1,4]diazepin-6-one; Desmethylpirenzepine; Pirenzepine Metabolite; LS-261; 5H-Dibenzo[b,e][1,4]diazepin-6-one, 11-[(4-methyl-1-piperazinyl)acetyl]-; 11-(4-Methyl-1-piperazinyl)acetyl-5H-dibenzo[b,e][1,4]diazepin-6-one
EINECS	Contact for details

Quality Control

Our n-Desmethyl Pirenzepine is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity, identity confirmation by spectroscopic methods (IR, NMR, MS), and residual solvent analysis to ensure compliance with ICH guidelines for impurities. A comprehensive Certificate of Analysis (COA) detailing all test results and specifications is provided with every shipment to support your quality and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere to ensure maximum 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)	Total impurities ≤2.0%
Single Unknown Impurity	≤0.5%
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.