Description

Temozolomide Impurity 16 is a specified impurity of the antineoplastic agent Temozolomide, identified by the CAS registry number 71749-37-6. This compound is critical for pharmaceutical research and development, serving as a key reference standard in the analytical characterization and quality control of Temozolomide drug substances and finished products. It is essential for laboratories and manufacturers focused on ensuring product safety, efficacy, and regulatory compliance. Professionals in pharmaceutical quality assurance, analytical chemistry, and impurity synthesis require this high-purity material for method validation and stability studies.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Temozolomide-related impurities in drug substances and products.
• Analytical Method Development & Validation: Critical component for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Batch Release Testing: Used in routine QC laboratories to monitor impurity levels against ICH Q3A/B guidelines, ensuring batch-to-batch consistency.
• Stability Studies: Employed to track the formation and growth of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and justify specifications.
• Research on Degradation Pathways: Aids in studying the chemical stability and decomposition mechanisms of Temozolomide.
• Synthesis Research: Can be used as an intermediate or starting material in synthetic chemistry research for novel analogs or related compounds.

Basic Information

Product Name	Temozolomide Impurity 16
CAS No.	71749-37-6
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; 1-Methyl-5-aminoimidazole-4-carboxamide; 4-Carbamoyl-5-amino-1-methylimidazole; 5-Amino-1-methyl-4-imidazolecarboxamide; AIC; 5-Aminoimidazole-4-carboxamide, 1-methyl-
EINECS	Contact for details

Quality Control

Every batch of Temozolomide Impurity 16 (CAS 71749-37-6) is manufactured and analyzed under strict quality systems. Our products undergo rigorous identity, purity, and impurity testing to ensure compliance with industry standards for reference materials. Comprehensive analytical data, including HPLC purity, is documented in a detailed Certificate of Analysis (COA), which is provided with each shipment. We support compliance with ICH Q3A, Q3B, and relevant pharmacopeial guidelines for impurity qualification.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. For long-term storage, consider storing desiccated at 2-8°C. Handle and store in accordance with good laboratory practices.

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)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w

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