Description

Levamisole Ep Impurity A is a high-purity reference standard critical for pharmaceutical quality control and analytical research. This compound serves as a specified impurity for the active pharmaceutical ingredient Levamisole, making it essential for ensuring drug safety and regulatory compliance. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and batch release testing.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of Levamisole-related impurities in drug substances and finished products.
• Analytical Method Development: Serves as a critical standard for developing and validating HPLC, UPLC, or GC methods in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control (QC) Testing: Employed in routine QC laboratories for system suitability tests and as a comparator in impurity assays to ensure batch-to-batch consistency.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Stability Studies: Used to monitor the formation of degradation products in Levamisole under various stress conditions.
• Research and Development: Aids in synthetic chemistry research for understanding degradation pathways and for the synthesis of related compounds.

Basic Information

Product Name	Levamisole Ep Impurity A
CAS No.	32190-34-4
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 A; Levamisole Impurity A; EP Impurity A; USP Related Compound A
EINECS	Contact for details

Quality Control

Every batch of Levamisole Ep Impurity A is manufactured and controlled under strict quality management systems. The product is characterized and qualified using advanced analytical techniques including HPLC, GC-MS, and NMR to ensure identity, purity, and traceability. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results against stringent in-house specifications aligned with pharmacopeial standards (EP, USP).

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). The product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (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)	≤ 0.5% w/w
Heavy Metals	≤ 20 ppm

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