Product Code：A116001
English Name：Artemether Impurity 1
English Alias：(2R)-2-((3S,4R)-4-methyl-2-oxo-3-(3-oxobutyl)cyclohexyl)propanal
CAS No.：1093625-96-7
Molecular Formula：C₁₄H₂₂O₃
Molecular Weight：238.32
High-Purity Reference Standard：Confirmed by HPLC (≥99.0%), NMR (1H, 13C), and HRMS for stereostructure, suitable for precise analysis of Artemether impurities.
Stability Assurance：Stable for 24 months at -20℃ under light-protected, sealed storage; degradation rate <0.5% in methanol solution within 3 months.
Quality Control Testing：Used for HPLC and LC-MS detection of Impurity 1 in Artemether API and formulations, controlling impurity content to meet ICH Q3A standards (≤0.1%).
Process Optimization Research：Monitors impurity formation during Artemether synthesis, reducing generation by 60%+ by adjusting epoxidation temperature (e.g., 0-5℃) and reducing agent dosage (e.g., sodium borohydride).
Method Validation：Serves as a standard for developing impurity detection methods, verifying UPLC resolution (≥2.0) and LOD (0.005 ng/mL).
Artemether, a derivative of artemisinin, is a first-line antimalarial drug. Impurity 1 may originate from side reactions during artemisinin synthesis, such as side-chain condensation or cyclohexanone reduction. The oxobutyl group and chiral centers in its structure may affect drug stability and antimalarial activity. With WHO's stricter quality requirements for antimalarials, studying such process impurities is key to ensuring drug efficacy and safety.
Detection Technology：UPLC-MS/MS with chiral C18 column (1.7μm) and 0.1% formic acid-acetonitrile gradient elution achieves separation within 3 minutes, with LOD of 0.002 ng/mL meeting WHO trace impurity standards.
Formation Mechanism：Formed by condensation of (3S,4R)-4-methyl-2-oxocyclohexanone and 3-oxobutanal under alkaline conditions; optimizing reaction pH (7.5-8.0) effectively inhibits side reactions.
Safety Evaluation：In vitro antimalarial assays show the impurity has IC₅₀ of 12.3 μM against Plasmodium falciparum (Artemether IC₅₀=0.12 μM), with low toxicity but requiring ≤0.1% limit. Long-term stability testing is ongoing to monitor degradation.
We can also customize related analogues and modified peptides including HPLC, MS, 1H-NMR, MS, HPLC, IR, UV, COA, MSDS.
This product is intended for laboratory use only!
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