Eravacycline Impurity 22(Hydrochloride) NEW

Eravacycline Impurity 22(Hydrochloride),6628-74-6

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

Product Information

• 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

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-water mixture within 6 months.

Applications

• 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).

Background Description

Research Status

• 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

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!