Description

Imatinib Para-Diaminomethylbenzene Impurity-D3 is a high-purity, isotopically labeled reference standard used for the accurate identification and quantification of related substances in active pharmaceutical ingredients (APIs). This compound is critical for ensuring the safety, efficacy, and regulatory compliance of pharmaceutical products, particularly in the development and quality control of the anticancer drug Imatinib Mesylate. It is an essential tool for analytical chemists and quality assurance professionals in pharmaceutical R&D and manufacturing, enabling precise method validation and impurity profiling.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the quantitative analysis of Imatinib and its related substances.
• Impurity Profiling & Method Development: Critical for developing and validating stability-indicating HPLC and LC-MS methods in pharmaceutical quality control laboratories.
• Drug Substance & Product Testing: Used to monitor and control the level of this specific impurity during the synthesis and final release testing of Imatinib API and finished dosage forms.
• Regulatory Compliance & Submissions: Supports the generation of data for regulatory filings (e.g., FDA, EMA) to demonstrate control over the drug's impurity profile as per ICH Q3A and Q3B guidelines.
• Stability Studies: Employed as an analytical marker in forced degradation and long-term stability studies to track impurity formation over time.
• Metabolism and Pharmacokinetic Studies: The deuterium-labeled (D3) structure makes it suitable for use as an internal standard in mass spectrometry-based bioanalytical assays.

Basic Information

Product Name	Imatinib Para-Diaminomethylbenzene Impurity-D3
CAS No.	1246819-27-1
Molecular Formula	C29H28D3N7O
Molecular Weight	~ 494.60 g/mol
Synonyms	Imatinib Impurity D3; 4-[(4-Methylpiperazin-1-yl)methyl]-N-[4-methyl-3-[(4-(pyridin-3-yl)pyrimidin-2-yl]amino-d3]phenyl]benzamide; N-{4-Methyl-3-[(4-(pyridin-3-yl)pyrimidin-2-yl)amino-d3]phenyl}-4-[(4-methylpiperazin-1-yl)methyl]benzamide; STI-571 Para-Diaminomethylbenzene Impurity-D3; Gleevec Impurity D3; Imatinib Mesylate Impurity D3; Deuterated Imatinib Impurity; Imatinib Related Compound D3
EINECS	Contact for details

Quality Control

Every batch of Imatinib Para-Diaminomethylbenzene Impurity-D3 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and isotopic enrichment testing using advanced techniques like NMR, HPLC, and LC-MS to ensure compliance with pharmacopeial standards for reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, isotopic purity (D-enrichment), and chromatographic profile.

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 under dry conditions to maintain stability and purity. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D-enrichment)	≥ 98 atom % D
Chemical Purity (NMR)	Conforms to structure
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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