AZD9291（Osimertinib） Impurity 19 NEW

AZD9291（Osimertinib） Impurity 1421373-31-0

Osimertinib (AZD9291) impurity reference standards are specialized control materials for pharmaceutical R&D, production, and quality assurance. They cover various impurities (e.g., Impurity 1 to 21) that may arise during the synthesis of osimertinib mesylate. These standards comply with GMP regulations and are provided with COA certificates and analytical data (HNMR, MS, HPLC) to ensure high purity and structural accuracy for drug submission and testing.

Product Features

1. Comprehensive Coverage: Includes key impurities for thorough impurity profiling and quality control.

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

3. Regulatory Compliance: Meets GMP and pharmacopeia standards (e.g., EP, USP) for global drug registration and research.

Quality Control Methods

• Quantitative Analysis: HPLC or LC-MS with correction factors to adjust response variability.

• Sensitivity & Accuracy: Detection limits as low as 0.005 μg/mL and quantification limits up to 0.015 μg/mL.

• Method Validation: Precision (RSD ≤2%) 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 osimertinib APIs and formulations.

• Quality Control: Routine impurity testing during drug manufacturing.

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

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