Keywords

• N-Nitroso Vancomycin
• 155386-25-7
• C66H74Cl2N10O25

Quick Details

• ProName: N-Nitroso Vancomycin
• CasNo: 155386-25-7
• Molecular Formula: C66H74Cl2N10O25
• 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

Azacitidine Impurity

Product Information

• Product Code：V034013

• English Name：N-Nitroso Vancomycin

• English Alias：N-Nitroso Vancomycin

• CAS No.：155386-25-7

• Molecular Formula：CHClNO

• Molecular Weight：1478.25

Advantages

• High-Purity Reference Standard：Confirmed by HPLC (≥99.0%), NMR (1H, 13C), HRMS, and elemental analysis, suitable for precise analysis of nitroso impurities in Vancomycin.

• Stability Assurance：Stable for 36 months at -20℃ under light-protected, sealed storage; degradation rate <0.1% in methanol-water solution within 6 months.

Applications

• Quality Control Testing：Used for UPLC-MS/MS detection of nitroso impurities in Vancomycin API and formulations, controlling content to meet ICH M7 standards (genotoxic impurity limit ≤1.5 μg/day).

• Process Optimization Research：Monitors formation of N-nitroso compounds during Vancomycin fermentation or purification, reducing generation by >40% by adjusting fermentation pH (e.g., 6.5-7.0) and avoiding nitrite exposure.

• Method Validation：Serves as a standard for developing nitrosamine impurity detection methods, verifying UPLC resolution (≥3.0) and LOD (0.005 ng/mL).

Background Description

Vancomycin, a glycopeptide antibiotic, is used for treating severe bacterial infections. N-Nitroso Vancomycin, as a potential genotoxic impurity, may form during Vancomycin production via reactions between free amino groups and nitrites or through spontaneous nitrosation under acidic storage conditions. Its nitrosamine group poses a mutagenic risk. With stricter FDA and EMA regulations on genotoxic impurities, studying such impurities is crucial for ensuring drug safety.

Research Status

• Detection Technology：UPLC-MS/MS with C18 column (1.7μm) and 0.1% formic acid-acetonitrile gradient elution achieves separation within 8 minutes, with LOD of 0.002 ng/mL for trace nitrosamine analysis.

• Formation Mechanism：Formed by reaction of amino groups in Vancomycin with sodium nitrite at pH <4; optimizing extraction system pH to neutral and using activated carbon adsorption inhibits its formation.

• Safety Evaluation：In vitro Ames tests show mutagenicity, with a permitted daily intake (TTC value) determined as 1.5 μg/day, requiring strict content control. Accelerated stability testing is ongoing to monitor nitrosation rates under different humidity and light conditions.