Imatinib Impurity 1356565-46-2

Product Overview
Imatinib impurity reference standards are critical control materials for pharmaceutical R&D, production, and quality assurance. They cover various potential impurities of Imatinib (Imatinib Mesylate), including Impurity A to I. These standards are supplied by GMP-compliant manufacturers with COA certificates and analytical data (HNMR, MS, HPLC), ensuring high purity and structural accuracy for drug registration and testing purposes.

Product Features

1. Comprehensive Coverage: Includes key impurities from Imatinib synthesis (e.g., piperidine-N-oxide, pyridine-N-oxide) for total quality control.

2. High Purity: Purity ≥95%, verified by NMR, MS, and other techniques for accurate quantification.

3. Regulatory Compliance: Meets GMP and pharmacopeia standards for drug submission and research.

Quality Control Methods

• Quantitative Analysis: HPLC or LC-MS with correction factors (e.g., Impurity A factor=1.2) to adjust response variability.

• Sensitivity: Detection limits as low as 0.004 μg/mL and quantification limits up to 0.014 μg/mL for trace impurity detection.

• Method Validation: Precision (RSD ≤2% for consecutive injections) and recovery (80%-120%) tested for reliability.

Packaging & Storage

• Packaging: Available in 10 mg, 25 mg, 50 mg, 100 mg vials, sealed and labeled with batch details.

• Storage: 2-8℃ (long-term) or 15-30℃ (short-term), protected from light and moisture.

Applications

• Pharmaceutical R&D: Impurity profiling of Imatinib APIs and formulations.

• Quality Control: Routine impurity testing during drug manufacturing.

• Regulatory Support: Complies with global pharmacopeial requirements for reference standards.