Description

Levamisole Impurity B CAS NO 20406-02-4 is a defined chemical reference standard used for the identification, qualification, and quantification of related substances in Levamisole Active Pharmaceutical Ingredient (API) and its formulations. This high-purity impurity standard is critical for ensuring product safety, efficacy, and regulatory compliance in pharmaceutical manufacturing. It is essential for analytical laboratories, quality control departments, and R&D teams within the pharmaceutical and fine chemical industries involved in method development, stability studies, and batch release testing.

Application

• Pharmaceutical Impurity Profiling and Control: Primary application as a certified reference material for the analysis of Levamisole API and drug products to meet ICH Q3A/B guidelines.
• Analytical Method Development and Validation: Used as a system suitability and calibration standard for HPLC, UPLC, and GC methods.
• Stability Indicating Studies: Employed to monitor the formation of degradation products in Levamisole under various stress conditions (e.g., heat, light, humidity).
• Quality Control and Batch Release Testing: Critical for setting and verifying specification limits for related substances in commercial production.
• Regulatory Submissions: Provides necessary data for Drug Master Files (DMFs), Common Technical Documents (CTD), and other regulatory filings to agencies like the FDA and EMA.
• Pharmacopoeial Testing: Supports testing in compliance with USP, EP, BP, and other pharmacopoeial monographs for Levamisole.

Basic Information

Product Name	Levamisole Impurity B
CAS No.	20406-02-4
Molecular Formula	C11H12N2S
Molecular Weight	204.29 g/mol
Synonyms	(S)-2,3,5,6-Tetrahydro-6-phenylimidazo[2,1-b]thiazole; (-)-Tetramisole; L-Tetramisole; (S)-(-)-2,3,5,6-Tetrahydro-6-phenylimidazo[2,1-b]thiazole; Levamisole Related Compound B; Levamisole EP Impurity B; Levamisole USP Related Compound B
EINECS	Contact for details

Quality Control

Every batch of Levamisole Impurity B is manufactured and controlled under a strict quality management system. The material undergoes comprehensive analytical testing, including HPLC purity determination, spectroscopic identification (IR, NMR, MS), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) with batch-specific data is provided, supporting traceability and compliance with cGMP and ISO 17034 guidelines for reference material producers.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent absorption of moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w

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