Description

Temozolomide Impurity 11(Not Continue) is a designated impurity reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Temozolomide. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by enabling accurate identification and quantification of process-related impurities. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) units, and regulatory affairs teams involved in the development and manufacturing of Temozolomide-based oncology treatments.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the identification and quantification of Temozolomide Impurity 11 in API and finished drug product batches.
• Method Development & Validation: Critical for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and related techniques.
• Stability Studies: Used to monitor the formation and levels of this specific impurity during forced degradation and long-term stability testing of Temozolomide.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary data on impurity profiles as required by ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control Testing: Enables routine in-process and release testing to ensure Temozolomide API meets stringent purity specifications.
• Process Chemistry Research: Aids in understanding and optimizing the Temozolomide synthesis pathway to minimize the formation of this impurity.

Basic Information

Product Name	Temozolomide Impurity 11(Not Continue)
CAS No.	1822762-32-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Temozolomide Related Compound 11; Temozolomide Impurity 11; Temozolomide EP Impurity 11; Temozolomide USP Impurity 11; 3-Methyl-4-oxo-3,4-dihydroimidazo[5,1-d][1,2,3,5]tetrazine-8-carboxamide derivative (Not Continue); Temozolomide Process Impurity; TMZ Impurity 11
EINECS	Contact for details

Quality Control

Every batch of Temozolomide Impurity 11(Not Continue) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced analytical techniques to ensure compliance with pharmacopeial standards (USP/EP) and ICH guidelines. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, assay, and related substances.

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 material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Assay	≥ 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%

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