Product Overview
Dabigatran Etexilate impurity reference standards are specialized control materials for the R&D, production, and quality assurance of the anticoagulant drug dabigatran etexilate. They cover various impurities (e.g., Impurity A, Z, M) that may arise during its synthesis. 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
Comprehensive Coverage: Includes key impurities for thorough impurity profiling and quality control.
High Purity: Purity ≥95%, verified by NMR, MS, and other techniques.
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 5 mg, 10 mg, 25 mg, 50 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 dabigatran etexilate 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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