Description

Asatra Impurity D (1-Methyl-2-(Methylsulfinyl)-5-Nitro-1H-Imidazole) is a high-purity reference standard and a key process-related impurity in the synthesis of active pharmaceutical ingredients (APIs). Its primary value lies in enabling rigorous quality control and analytical method development for pharmaceutical manufacturers, ensuring the safety and efficacy of final drug products. This compound is essential for research, development, and quality assurance laboratories within the global pharmaceutical and life sciences industries.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in drug substances and finished products.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, and LC-MS methods to monitor impurity profiles during API synthesis.
• Process Chemistry Research: Employed in studying reaction pathways, optimizing synthesis conditions, and controlling impurity formation in pharmaceutical manufacturing.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Quality Control (QC) Testing: Serves as a system suitability and calibration standard in routine QC testing of APIs and finished dosage forms.
• Academic & Contract Research: Used in universities and CROs for pharmacological studies and impurity synthesis research.

Basic Information

Item	Details
Product Name	Asatra Impurity D / 1-Methyl-2-(Methylsulfinyl)-5-Nitro-1H-Imidazole
CAS No.	56302-26-2
Molecular Formula	C6H9N3O3S
Molecular Weight	203.22 g/mol
Synonyms	1-Methyl-2-(methylsulfinyl)-5-nitroimidazole; 2-(Methylsulfinyl)-1-methyl-5-nitro-1H-imidazole; Asatra Impurity D; 1-Methyl-2-methylsulfinyl-5-nitroimidazole; 5-Nitro-1-methyl-2-methylsulfinylimidazole; 1-Methyl-5-nitro-2-methylsulfinylimidazole; 56302-26-2; UNII-5J7Q8Q3Y1R
EINECS	Contact for details

Quality Control

Every batch of Asatra Impurity D is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, GC, NMR, and mass spectrometry to ensure compliance with pharmaceutical industry standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

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 compound is light-sensitive and should be handled under appropriate conditions to maintain 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% Any single impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w

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