Product Code：U001058
English Name：Urapidil Impurity 58
English Alias：3-(6-amino-1,3-dimethyl-2,4-dioxo-1,2,3,4-tetrahydropyrimidin-5-yl)-3-oxopropanoic acid
CAS No.：1308677-74-8
Molecular Formula：C₉H₁₁N₃O₅
Molecular Weight：241.20
High Purity and Structure Confirmation：Purity ≥99.0% by HPLC, structure confirmed by NMR and HRMS, providing a reliable reference standard for Urapidil impurity analysis.
Excellent Stability：Stable for 24 months under 2-8℃ in light-protected, sealed storage; degradation rate <0.3% in acetonitrile-water solution within 1 month, ensuring stable detection data.
Quality Control Testing：Used for HPLC and LC-MS detection of Impurity 58 in Urapidil API and formulations, strictly controlling impurity content to meet ICH Q3A standards (≤0.1%).
Process Optimization Research：Monitor the generation of this impurity during Urapidil synthesis, reduce impurity formation by adjusting the temperature (e.g., 80-90℃) and pH (weak alkaline conditions) of pyrimidine ring condensation reaction.
Analytical Method Validation：Serves as a reference standard for developing and validating Urapidil impurity detection methods, evaluating method specificity, sensitivity, and repeatability.
Urapidil is an antihypertensive drug with both peripheral and central effects. During its synthesis, various impurities may be generated due to raw material residues, reaction conditions, or side reactions. Impurity 58, as a process-related impurity of Urapidil, contains a pyrimidine dione group in its structure, which may affect the drug's stability and safety. With the improvement of global pharmaceutical regulatory requirements, the research and control of such impurities have become an important part of ensuring Urapidil quality.
Detection Technology：UPLC-MS/MS is adopted with a C18 column (1.7μm, 2.1×100mm) and 0.1% formic acid water-acetonitrile gradient elution, completing separation within 1.5 minutes with a detection limit as low as 0.002 ng/mL.
Formation Mechanism：Research shows that Impurity 58 may originate from the side reaction in the pyrimidine ring construction step of Urapidil synthesis, that is, the condensation of aminomalonic acid and dimethylurea. By optimizing the ratio of condensation reagents (such as reducing the excess ratio of dimethylurea) and reaction time (≤6 hours), the impurity content can be reduced by more than 60%.
Safety Evaluation：Preliminary toxicological experiments show that Impurity 58 has no obvious toxicity to in vitro cells (such as HEK293) at high concentrations, but further animal experiments are needed to evaluate its long-term exposure risk. The current drug quality standard sets its limit at ≤0.1%.
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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