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CAS NO.5439-87-2
1(10.0-10000)Milligram
Advantages
High-Purity Guarantee：Confirmed by HPLC with a purity of ≥99.0%, and the structure is verified through multiple methods including NMR (1H, 13C), HRMS, and elemental analysis, providing an accurate and reliable reference standard for Carbocisteine impurity analysis.
Good Stability：Stable for 36 months under storage conditions of -20℃ in the dark and sealed. The degradation rate is less than 0.3% within 6 months in common solvent systems such as methanol - water, ensuring stable and reliable experimental data.
Carbocisteine Impurity ;5439-87-2
Product Information
Product Code：C049009
English Name：Carbocisteine Impurity 9
English Alias：(2R)-2-amino-3-((carboxymethyl)sulfinyl)propanoic acid
CAS No.：5439-87-2
Molecular Formula：C?H?NO?S
Molecular Weight：195.19
Applications
Quality Control Testing：Used for the UPLC-MS/MS detection of Impurity 9 in Carbocisteine active pharmaceutical ingredients and formulations. Strictly control the impurity content to meet the ICH Q3A standards (single impurity limit ≤0.1%), ensuring drug quality and safety.
Process Optimization Research：Monitor the formation pathway of this impurity during the synthesis of Carbocisteine. By adjusting parameters such as the oxidation reaction temperature (e.g., 40 - 50℃), reaction time, and oxidant dosage, the generation of impurities can be reduced by more than 40%.
Method Validation：As a standard for developing impurity detection methods, it can verify the resolution (≥3.0) and limit of detection (0.01 ng/mL) of UPLC, ensuring the accuracy and reliability of the detection method.
Background Description
Carbocisteine is a mucolytic agent mainly used for treating symptoms such as thick sputum and difficult expectoration caused by diseases like chronic bronchitis and bronchial asthma. Impurity 9, as a process-related impurity in the synthesis of Carbocisteine, may originate from side products of reactions such as thiol oxidation and carboxymethylation. Functional groups such as sulfinyl, amino, and carboxyl in its structure may affect drug stability, solubility, and efficacy. With the continuous improvement of regulatory requirements for respiratory drug quality, the study of Impurity 9 has become an important part of ensuring the quality and safety of Carbocisteine.
Research Status
Detection Technology：UPLC-MS/MS technology is used, combined with a C18 column (1.7μm) and gradient elution with 0.1% formic acid - acetonitrile. Impurities can be separated within 6 minutes, and the limit of detection is as low as 0.005 ng/mL, enabling precise detection of trace impurities.
Formation Mechanism：Studies have shown that Impurity 9 may be formed by the oxidation of the thiol group to a sulfinyl group under mild oxidation conditions (such as hydrogen peroxide/acetic acid system) and simultaneous carboxymethylation of the precursor compound. Optimizing the pH of the reaction system and oxidation conditions can effectively inhibit the generation of this impurity.
Safety Evaluation：In vitro cytotoxicity experiments show that the half-maximal inhibitory concentration (IC??) of this impurity against A549 cells is 185.6 μM (Carbocisteine IC?? = 12.3 μM). Although the toxicity is lower than that of the main drug, its content in drugs still needs to be strictly controlled. Currently, long-term stability tests are being carried out to monitor its degradation characteristics under different humidity, light, and temperature conditions.