Keywords

• Amphotericin B Impurity D
• C48H75NO17
• Amphotericin

Quick Details

• ProName: Amphotericin B Impurity D
• Molecular Formula: C48H75NO17
• 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

Amphotericin B Impurity D

Product Information

• Product Code：A096005

• English Name：Amphotericin B Impurity D

• English Alias：(1S,3S,5R,6R,9R,11R,15S,16R,17R,18S,19E,21E,23E,25E,27E,29E,31E,33R,35S,36R,37S)-33-(((2S,3S,4S,5S,6R)-4-amino-3,5-dihydroxy-6-methyltetrahydro-2H-pyran-2-yl)oxy)-3,5,6,9,11,17,37-heptahydroxy-1-methoxy-15,16,18-trimethyl-13-oxo-14,39-dioxabicyclo[33.3.1]nonatriaconta-19,21,23,25,27,29,31-heptaene-36-carboxylic acid

• CAS No.：[Not Available]

• Molecular Formula：C??H??NO??

• Molecular Weight：938.11

Advantages

• High-Purity Reference Standard：Confirmed by HPLC (≥99.0%), NMR (1H, 13C), HRMS, and circular dichroism for stereostructure, suitable for precise analysis of Amphotericin B impurities.

• Stability Assurance：Stable for 24 months at -20℃ under light-protected, sealed storage; degradation rate <0.5% in DMSO solution within 3 months.

Applications

• Quality Control Testing：Used for UPLC-MS/MS detection of Impurity D in Amphotericin B API and formulations, controlling impurity content to meet ICH Q3A standards (≤0.1%).

• Process Optimization Research：Monitors impurity formation during Amphotericin B fermentation or semi-synthesis, reducing generation by >40% by adjusting fermentation temperature (e.g., 26-28℃) and precursor dosage.

• Method Validation：Serves as a standard for developing impurity detection methods, verifying UPLC resolution (≥2.5) and LOD (0.01 ng/mL).

Background Description

Amphotericin B, a first-line drug for deep fungal infections, belongs to polyene antibiotics. Impurity D may originate from degradation or structural isomerization of Amphotericin B during fermentation. Its complex polyene structure and glycosyl side chain may affect drug stability and antifungal activity. With stricter WHO quality requirements for antifungal drugs, studying such process and degradation impurities is key to ensuring efficacy and safety.

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 analysis.

• Formation Mechanism：May form via etherification of C33 hydroxyl group of Amphotericin B with glycosyl or cyclization under acidic conditions (pH <5). Optimizing purification (e.g., reverse-phase chromatography) and storage (low temperature, light protection) inhibits its formation.

• Safety Evaluation：In vitro antifungal assays show MIC of 8 μg/mL against Candida albicans (Amphotericin B MIC=0.25 μg/mL), with low toxicity but requiring ≤0.1% limit. Long-term stability testing is ongoing to monitor complex degradation with metal ions (e.g., Fe³?).

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

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