Description

Imatinib Impurity 38 is a designated process-related impurity and reference standard used in the pharmaceutical development and quality control of the active pharmaceutical ingredient (API) Imatinib Mesylate. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by enabling accurate identification and quantification during analytical testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the production and validation of anticancer medications.

Application

• Pharmaceutical Reference Standard: Serves as a certified external standard for the quantitative and qualitative analysis of Imatinib Mesylate API and finished drug products.
• Method Development and Validation: Essential for developing, optimizing, and validating stability-indicating analytical methods such as HPLC and UPLC.
• Quality Control & Batch Release: Used in routine QC testing to monitor and control the level of this specific impurity, ensuring compliance with ICH Q3A/B guidelines.
• Stability Studies: Employed to identify and track impurity profiles in forced degradation and long-term stability studies of Imatinib formulations.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to establish impurity thresholds and control strategies.
• Research and Development: Used in synthetic chemistry research to study the formation pathways and chemical behavior of Imatinib-related substances.

Basic Information

Product Name	Imatinib Impurity 38
CAS No.	1407124-83-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Imatinib Related Compound 38; Imatinib EP Impurity I; Imatinib USP Impurity; N-[4-Methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]phenyl]-4-[(4-methyl-1-piperazinyl)methyl]benzamide Impurity; Gleevec Impurity 38; STI-571 Impurity 38; Imatinib Mesylate Impurity 38; Imatinib Free Base Impurity
EINECS	Contact for details

Quality Control

Our Imatinib Impurity 38 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC purity, identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment to support your regulatory and quality assurance needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 0.5%; Total impurities ≤ 1.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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