grade
pharmaceutical primary standard
agency
USP
API family
amphotericin b
form
solid
manufacturer/tradename
USP
application(s)
USP Biologics
pharmaceutical (small molecule)
format
neat
storage temp.
−20°C
SMILES string
N[C@@H]1[C@@H]([C@@H](O[C@@H]([C@H]1O)C)O[C@@H]2C[C@@H]3O[C@@](C[C@@H]([C@H]3C(=O)O)O)(C[C@H](C[C@H]([C@@H](CC[C@H](C[C@H](CC(=O)O[C@H]([C@@H]([C@@H]([C@H](\C=C/C=C\C=C/C=C\C=C/C=C\C=C/2)C)O)C)C)O)O)O)O)O)O)O
InChI
1S/C47H73NO17/c1-27-17-15-13-11-9-7-5-6-8-10-12-14-16-18-34(64-46-44(58)41(48)43(57)30(4)63-46)24-38-40(45(59)60)37(54)26-47(61,65-38)25-33(51)22-36(53)35(52)20-19-31(49)21-32(50)23-39(55)62-29(3)28(2)42(27)56/h5-18,27-38,40-44,46,49-54,56-58,61H,19-26,48H2,1-4H3,(H,59,60)/b6-5-,9-7-,10-8-,13-11-,14-12-,17-15-,18-16-/t27-,28-,29-,30+,31+,32+,33-,34-,35+,36+,37-,38-,40+,41-,42+,43+,44-,46-,47+/m0/s1
InChI key
APKFDSVGJQXUKY-ZNVUZQDLSA-N
General description
Amphotericin B is a polyene antifungal agent that binds to ergosterol, disrupting fungal cell membrane integrity. It is used for systemic fungal infections. The USP reference standard is essential for potency determination and impurity analysis in amphotericin B drug products.
The USP biologics antibiotics category includes a wide range of antimicrobial agents that are essential in treating bacterial infections. These antibiotics are derived from various natural sources or synthesized to combat specific pathogens effectively. The USP provides comprehensive standards, reference materials, and analytical procedures to ensure the identity, quality, purity, and consistency of antibiotic therapeutics throughout their lifecycle.
The United States Pharmacopeia (USP) provides quality standards for biologics to ensure their safety, efficacy, and quality throughout the manufacturing process. These standards assist manufacturers in adhering to regulatory requirements and help safeguard public health by reducing risks associated with biologics.
Application
Also used to prepare standard and system suitability solutions as described in the following United States Pharmacopeia (USP) monographs:
- Amphotericin B
- Amphotericin B for Injection
Analysis Note
Other Notes
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存储类别
11 - Combustible Solids
flash_point_f
Not applicable
flash_point_c
Not applicable
target_organs
Respiratory system
signalword
Warning
hcodes
Hazard Classifications
Eye Irrit. 2 - Skin Irrit. 2 - STOT SE 3