Description

Satra Impurity G, 1-(1-Methyl-4-Nitro-1H-Imidazol-2-Yl)-3-(Methylsulfonyl)Imidazolidin-2-One is a high-purity reference standard and process impurity critical for pharmaceutical quality control. This compound is essential for the analytical validation and monitoring of active pharmaceutical ingredients (APIs) during development and manufacturing. It is primarily used by research institutions, analytical laboratories, and pharmaceutical companies involved in the synthesis and quality assurance of complex drug substances.

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 (HPLC/LC-MS): Serves as a critical component in developing and validating chromatographic methods for impurity profiling.
• Process Chemistry Monitoring: Employed to track and control the formation of this specific impurity during the synthesis of related APIs, ensuring process robustness.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Stability Studies: Used as a marker in forced degradation and long-term stability studies to understand the degradation pathways of pharmaceutical compounds.
• Quality Control (QC) Laboratory Testing: Provides a benchmark for routine QC testing to ensure batch-to-batch consistency and final product safety.

Basic Information

Product Name	Satra Impurity G
CAS No.	56302-24-0
Molecular Formula	C9H13N5O5S
Molecular Weight	303.30 g/mol
Synonyms	1-(1-Methyl-4-nitro-1H-imidazol-2-yl)-3-(methylsulfonyl)imidazolidin-2-one; Satra Impurity G; 1-(1-Methyl-4-nitroimidazol-2-yl)-3-(methylsulfonyl)-2-imidazolidinone; 2-Imidazolidinone, 1-(1-methyl-4-nitro-1H-imidazol-2-yl)-3-(methylsulfonyl)-; UNII-6Q2I7803JN; 6Q2I7803JN
EINECS	Contact for details

Quality Control

Our Satra Impurity G is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and spectroscopic identification (IR, NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profile is provided with every shipment.

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) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% 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.