Description

Baclofen Impurity 6 is a specified impurity and degradation product of the active pharmaceutical ingredient Baclofen, a muscle relaxant. This compound is critical for pharmaceutical research and development, serving as a key reference standard for quality control and regulatory compliance. It is primarily required by analytical laboratories, pharmaceutical manufacturers, and regulatory bodies for method development, validation, and ensuring the purity and safety of Baclofen-based drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Baclofen API and finished dosage forms.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or GC methods to monitor impurity profiles during drug manufacturing.
• Quality Control & Assurance: Employed in routine QC testing to ensure Baclofen batches meet pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B guidelines) for impurity limits.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) to establish drug shelf-life.
• Regulatory Submissions: Critical for preparing impurity characterization reports and documentation required for drug master files (DMFs), ANDAs, and INDs.
• Research & Synthesis: Serves as an intermediate or starting material in chemical synthesis for related compound research and impurity isolation studies.

Basic Information

Item	Details
Product Name	Baclofen Impurity 6
CAS No.	28311-44-6
Molecular Formula	C10H12ClNO2
Molecular Weight	213.66 g/mol
Synonyms	4-[(4-Chlorophenyl)(hydroxy)methyl]butanoic acid; 4-[(4-Chlorophenyl)hydroxymethyl]butyric acid; 4-(4-Chlorobenzhydryloxy)butyric acid; Baclofen Related Compound B (USP); Baclofen Impurity B; Baclofen EP Impurity B; β-(4-Chlorophenyl)-γ-hydroxybutyric acid; Lioresal Impurity B
EINECS	Contact for details

Quality Control

Every batch of Baclofen Impurity 6 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing to ensure compliance with pharmaceutical reference standard requirements. Comprehensive analytical data, including HPLC chromatograms and spectral data (IR, NMR, MS), are maintained. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming batch-specific purity and traceability.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. The material is light-sensitive and should be handled under appropriate conditions to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 0.5% w/w
Residue on Ignition	≤ 0.1%

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