Description

Temozolomide Impurity 23 is a specified impurity and reference standard used in the analytical profiling of the active pharmaceutical ingredient (API) Temozolomide. Its precise identification and quantification are critical for ensuring the purity, safety, and efficacy of the final drug product in accordance with stringent pharmacopeial guidelines. This compound is essential for pharmaceutical R&D, quality control laboratories, and manufacturers involved in the production and regulatory compliance of Temozolomide-based oncology treatments.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of this specific impurity in Temozolomide API and finished dosage forms.
• Method Development and Validation: Critical for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and related techniques.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to monitor impurity levels and ensure compliance with ICH Q3A/B guidelines and pharmacopeial monographs (USP, EP).
• Stability Studies: Employed to track the formation and growth of this impurity over time under various stress conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Common Technical Documents (CTDs), and other regulatory filings to demonstrate comprehensive impurity control.
• Research and Development: Supports studies on the degradation pathways and chemical behavior of Temozolomide during synthesis and formulation.

Basic Information

Product Name	Temozolomide Impurity 23
CAS No.	57052-92-3
Molecular Formula	C6H6N6O2
Molecular Weight	194.15 g/mol
Synonyms	5-Amino-1-methyl-1H-imidazole-4-carboxamide; 5-Amino-1-methylimidazole-4-carboxamide; NSC 407347; AIC; 5-Aminoimidazole-4-carboxamide, 1-methyl-; 1-Methyl-5-aminoimidazole-4-carboxamide; 4-Carbamoyl-5-amino-1-methylimidazole; 1-Methyl-5-amino-1H-imidazole-4-carboxamide
EINECS	Contact for details

Quality Control

Every batch of Temozolomide Impurity 23 is manufactured and tested under a strict quality management system. Our products undergo rigorous analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure they meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator after opening to maintain stability and purity.

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%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm

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