Keywords

• Eravacycline Difference phase isomer
• 1431558-65-4
• C27H31FN4O8

Quick Details

• ProName: Eravacycline Difference phase isomer;1...
• CasNo: 1431558-65-4
• Molecular Formula: C27H31FN4O8
• Appearance: White to off white powder
• Application: for drug impurity for drug standards,f...
• DeliveryTime: 1-2 weeks
• PackAge: 10mg/25mg/50mg/100mg/1000mg/5000mg
• Port: Shenzhen/hongkong
• ProductionCapacity: 5000 Metric Ton/Day
• Purity: 95%+ or 98%+
• Storage: -20℃
• LimitNum: 25 Milligram
• Moisture Content: 0.1%
• Impurity: 0.1%

Superiority

Our products are mainly drug impurity reference products, drug standards, analytical chemistry, standard substances, organic chemical synthesis, chemical custom synthesis. For impurity localization, quantification, and quality control in drug development processes. Our laboratory area is more than 5000 square meters, we have more than 20 analytical instruments such as HPLC and MS/LC-MS/GC-MS, we also have TGA, IR and other testing instruments. We have the most advanced SFC preparation separation equipment. We can provide a full range of impurity reference/standard products required for drug development. Most of the impurities are synthesized through the process, there are also many items of impurities can not be obtained by synthetic means, need to be obtained through raw materials, intermediates, crude products or side reactions contained in the trace target compounds, Hubei Moke has a professional impurity preparation and separation technology team, equipped with professional SFC preparation and separation equipment. It can carry out efficient and accurate separation of impurities for complex projects, and solve the problem of impurity preparation for customers.
 

1. We integrate R&D, production and sales. A 5,000-square-meter high-standard bio-intelligent manufacturing base can ensure high quality and fast delivery of products. The professional sales team ensures that you don't need to worry about pre-sales and after-sales.

2. We focus on pharmaceutical standards, pharmaceutical intermediates, pharmaceutical impurity controls, peptide customization, our own laboratory, and undertake customized synthesis projects.

3. We offer products from gram grade to g grade, in addition, some product specifications and packaging can be customized.

4. We have been deeply engaged in the pharmaceutical field for ten years and have rich experience. At present, customers are all over the world, and have been highly recognized and trusted by customers.

5. We can provide a variety of safe ways to transport goods for you to choose.

Details

Eravacycline Difference phase isomer

Product Information

• Product Code：E062018

• English Name：Eravacycline Difference phase isomer

• English Alias：(4R,4aS,5aR,12aS)-4-(dimethylamino)-7-fluoro-3,10,12,12a-tetrahydroxy-1,11-dioxo-9-(2-(pyrrolidin-1-yl)acetamido)-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide

• CAS No.：1431558-65-4

• Molecular Formula：C??H??FN?O?

• Molecular Weight：558.56

Advantages

• High-Purity Isomer Reference Standard：Confirmed by HPLC (≥99.0%), NMR (with chiral shift reagents), HRMS, and X-ray crystallography for stereoconfiguration, suitable for precise analysis of Eravacycline difference phase isomers.

• Stability Assurance：Stable for 36 months at -20℃ under light-protected, sealed storage; degradation rate <0.2% in methanol-water solution within 6 months.

Applications

• Quality Control Testing：Used for UPLC-MS/MS detection of difference phase isomers in Eravacycline API and formulations, controlling isomer content to meet ICH Q3A standards (≤0.5%).

• Process Optimization Research：Monitors difference isomerization side reactions during Eravacycline synthesis, reducing generation by >60% by adjusting hydrogenation temperature (e.g., 10-15℃) and catalyst dosage (e.g., Pd/C).

• Method Validation：Serves as a standard for developing isomer separation methods, verifying UPLC resolution (≥3.0) and LOD (0.01 ng/mL).

Background Description

Eravacycline, a new-generation tetracycline antibiotic, is used for treating complicated intra-abdominal infections. Difference phase isomers may originate from stereoisomerization of the octahydrotetracene ring during Eravacycline synthesis. The polyhydroxy and chiral centers in its structure may affect drug antibacterial activity and safety. With stricter FDA requirements for antibiotic isomer control, studying such steric impurities is key to ensuring drug quality.

Research Status

• Detection Technology：UPLC-MS/MS with chiral C18 column (1.7μm) and 0.1% phosphoric acid-water-acetonitrile gradient elution achieves separation within 4 minutes, with LOD of 0.005 ng/mL for high-sensitivity analysis.

• Formation Mechanism：Formed by epimerization of Eravacycline parent nucleus during hydrogenation; optimizing reaction pressure (e.g., 5-10 atm) and solvent polarity (e.g., ethanol-water system) inhibits side reactions.

• Safety Evaluation：In vitro antibacterial assays show MIC of 4 μg/mL against E. coli (Eravacycline MIC=0.5 μg/mL), with low toxicity but requiring ≤0.5% limit. Accelerated stability testing is ongoing to monitor isomerization rates under different pH conditions

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 17320513646
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!