Description

Temozolomide Impurity CAS NO 196806-10-7 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of the oncology drug Temozolomide. This compound is critical for ensuring the safety and efficacy of the final drug product by enabling the accurate identification, quantification, and control of related substances. It is an essential material for analytical chemists and quality assurance professionals in pharmaceutical R&D and manufacturing, particularly for those working on antineoplastic agents.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the qualitative and quantitative analysis of Temozolomide and its related substances.
• Method Development and Validation: Critical for developing and validating robust analytical methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control (QC) Testing: Used in routine QC laboratories to monitor and control impurity levels in Temozolomide Active Pharmaceutical Ingredient (API) and finished drug products to meet ICH guidelines.
• Stability Studies: Employed to identify and track degradation products that may form during the stability testing of Temozolomide under various stress conditions.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive impurity understanding and control strategies.
• Research and Development: Supports synthetic route optimization and process chemistry research by helping to identify and characterize process-related impurities.

Basic Information

Product Name	Temozolomide Impurity
CAS No.	196806-10-7
Molecular Formula	C6H6N6O2
Molecular Weight	194.15 g/mol
Synonyms	3-Methyl-4-oxo-3,4-dihydroimidazo[5,1-d][1,2,3,5]tetrazine-8-carboxamide; Temozolomide Related Compound; Temozolomide Impurity A; 8-Carbamoyl-3-methylimidazo[5,1-d]-1,2,3,5-tetrazin-4(3H)-one; Imidazo[5,1-d][1,2,3,5]tetrazine-8-carboxamide, 3,4-dihydro-3-methyl-4-oxo-; MTIC Degradant
EINECS	Contact for details

Quality Control

Every batch of Temozolomide Impurity CAS NO 196806-10-7 is manufactured and tested under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure compliance with industry standards for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profile is provided with each shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a 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 powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity: ≤ 0.5% 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.