Eravacycline Impurity 23 NEW

Eravacycline Impurity 23;94391-95-4

WhatsAPP: +86 17386083646
E-mail: anna@molcoo.com

• Product Information

• Product Code：E062023

• English Name：Eravacycline Impurity 23

• English Alias：tert-butyl 2-(pyrrolidin-1-yl)acetate

• CAS No.：94391-95-4

• Molecular Formula：C₁₀H₁₉NO₂

• Molecular Weight：185.26

• Advantages

• 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-acetonitrile mixture within 6 months.

• Applications

• Quality Control Testing：Used for UPLC-MS/MS detection of Impurity 23 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 >35% by adjusting esterification temperature (e.g., 50-60℃) 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).

• Background Description

• Eravacycline, a novel tetracycline antibiotic, is used for treating complicated intra-abdominal infections by inhibiting bacterial protein synthesis. Impurity 23, a process-related impurity in its synthesis, may originate from esterification side reactions of pyrrolidine acetic acid with tert-butanol or abnormal Boc protection steps. Its pyrrolidine ring, ester group, and tert-butyl group may affect drug lipophilicity, metabolic stability, and antibacterial activity. Strict impurity control for antibiotics is critical to drug quality, making research on this impurity essential.

• Research Status

• Detection Technology：UPLC-MS/MS with C18 column (1.7μm) and 0.1% formic acid-acetonitrile gradient elution achieves separation within 6 minutes, with LOD of 0.005 ng/mL for trace impurity analysis.

• Formation Mechanism：Formed by esterification of 2-(pyrrolidin-1-yl)acetic acid with tert-butanol under acidic catalyst (e.g., p-toluenesulfonic acid); optimizing catalyst dosage and reaction pH inhibits side reactions.

• Safety Evaluation：In vitro cytotoxicity shows IC₅₀ of 198.3 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 ester hydrolysis risks 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

NEW IN STOCK!

The Molcoo Laboratory added drug impurity reference standards, including Baricitinib, Piperazine, Benzylpenicillin, Tranilast and multiple N-Nitroso drug impurities! Now available for immediate delivery!