Amphotericin B Impurity D NEW

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：C₄₈H₇₅NO₁₇

• 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

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⁺).