Description

Buflomedil Impurity (o-Desmethyl) is a key chemical reference standard used in the pharmaceutical development and quality control of Buflomedil. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions for method validation, stability studies, and impurity profiling.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of o-Desmethyl Buflomedil in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating sensitive HPLC, UPLC, or LC-MS methods to monitor impurity levels in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies & Forced Degradation: Used to identify and track degradation products formed during stability testing of Buflomedil under various stress conditions (e.g., heat, light, humidity).
• Quality Control & Batch Release: Critical for routine quality control testing to ensure impurity specifications are met for every batch of Buflomedil API, supporting GMP compliance.
• Regulatory Submissions: Provides necessary data and a characterized standard for inclusion in regulatory filings (e.g., DMF, CMC sections) to health authorities like the FDA and EMA.
• Research & Process Chemistry: Used in research to understand the metabolic pathways and degradation mechanisms of Buflomedil, aiding in process optimization and impurity control strategy.

Basic Information

Product Name	Buflomedil Impurity (o-Desmethyl)
CAS No.	70585-57-8
Molecular Formula	C₁₇H₂₅NO₄
Molecular Weight	307.39 g/mol
Synonyms	o-Desmethyl Buflomedil; 4-(1-Pyrrolidinyl)-1-(2,4,6-trimethoxyphenyl)-1-butanone; 1-(2,4,6-Trimethoxyphenyl)-4-(pyrrolidin-1-yl)butan-1-one; Buflomedil Desmethyl Impurity; Buflomedil Related Compound; Buflomedil Metabolite; Loftyl Impurity; CAS 70585-57-8
EINECS	Contact for details

Quality Control

Our Buflomedil Impurity (o-Desmethyl) is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure the highest standards of identity, purity, and stability. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from advanced chromatographic and spectroscopic methods, including HPLC purity, related substances, and structural confirmation. We support compliance with ICH, USP, and EP guidelines for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccated conditions.

Specification

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

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