Eravacycline Impurity 22(Hydrochloride),6628-74-6
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E-mail: anna@molcoo.com
Product Code：E062022A
English Name：Eravacycline Impurity 22(Hydrochloride)
English Alias：2-(pyrrolidin-1-yl)acetic acid hydrochloride
CAS No.：6628-74-6
Molecular Formula：C₆H₁₁NO₂·HCl
Molecular Weight：165.62
High-Purity Reference Standard：Confirmed by HPLC (≥99.0%), NMR (1H, 13C), HRMS, and elemental analysis, suitable for Eravacycline impurity analysis and quality control.
Stability Assurance：Stable for 36 months at -20℃ under light-protected, sealed storage; degradation rate <0.3% in methanol-water mixture within 6 months.
Quality Control Testing：Used for UPLC-MS/MS detection of Impurity 22 in Eravacycline API and formulations, controlling content to meet ICH Q3A standards (single impurity limit ≤0.1%).
Process Optimization Research：Monitors impurity formation during Eravacycline synthesis, reducing generation by >30% by adjusting pyrrolidine substitution temperature (e.g., 40-50℃) and reaction time.
Method Validation：Serves as a standard for developing impurity detection methods, verifying UPLC resolution (≥3.0) and LOD (0.01 ng/mL).
Eravacycline, a novel tetracycline antibiotic, is used for treating complicated intra-abdominal infections by inhibiting bacterial protein synthesis. Impurity 22, a process-related impurity in its synthesis, may originate from hydrochlorination side reactions of pyrrolidine acetic acid intermediates or residual during purification. Its pyrrolidine ring, carboxyl group, and hydrochloride may affect drug water solubility, stability, and antibacterial activity. Strict impurity control for antibiotics is critical to drug quality, making research on this impurity essential.
Detection Technology：UPLC-MS/MS with C18 column (1.7μm) and 0.1% formic acid-acetonitrile gradient elution achieves separation within 5 minutes, with LOD of 0.005 ng/mL for trace impurity analysis.
Formation Mechanism：Formed by reaction of pyrrolidin-1-ylacetic acid with hydrogen chloride gas in ethanol; optimizing reaction temperature and HCl dosage inhibits side reactions.
Safety Evaluation：In vitro cytotoxicity shows IC₅₀ of 210.5 μM against Vero cells (Eravacycline IC₅₀=8.7 μM), with lower toxicity than the main drug but requiring strict content control. Long-term stability testing is ongoing to monitor degradation under high temperature and humidity conditions.
NOTE！
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!
WhatsAPP: +86 17386083646
E-mail: anna@molcoo.com
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