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Postion:Product Catalog >Amphotericin B Impurity D
Amphotericin B Impurity D
  • Amphotericin B Impurity D
  • Amphotericin B Impurity D
  • Amphotericin B Impurity D
  • Amphotericin B Impurity D
  • Amphotericin B Impurity D

Amphotericin B Impurity D NEW

Price Get Latest Price
Package 10mg 50mg 100mg
Min. Order: 10mg
Supply Ability: 1000
Update Time: 2025-06-18

Product Details

Product Name: Amphotericin B Impurity D Min. Order: 10mg
Purity: 99%+ HPLC Supply Ability: 1000
Release date: 2025/06/18

Amphotericin B Impurity D

Article illustration

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


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! 








Company Profile Introduction

1. Drug standards and drug impurity reference substances: provide more than 20,000 kinds of spot impurity reference substances, with sufficient supply and same-day delivery. We have a professional R&D team and comprehensive quality control testing to ensure product quality and reliability. 2. Customized synthesis of impurities and new molecules: Quickly respond to the customized needs of CDE impurities, stably supply impurities that have established quality standards, and provide customized synthesis services for new compounds in the research and development of innovative drugs. 3. Preparation and separation of unknown impurities: With a professional impurity preparation and separation technical team and SFC preparation and separation instruments, we can solve the problems of impurity preparation in complex projects. 4. Process development of new drug intermediates: provide the supply of new drugs and new molecular impurities, process optimization services, as well as the screening and impurity analysis of commercialization routes. 5. Peptide synthesis: Provide customized peptide synthesis services, and cover all kinds of degradation impurities and process impurities generated in the research and development of peptide drugs. At the same time, it provides comprehensive structural confirmation data and customized testing services.

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