1032007

Amphotericin B

United States Pharmacopeia (USP) Reference Standard

• Empirische Formel (Hill-System): C₄₇H₇₃NO₁₇
• CAS-Nummer: 1397-89-3
• Molekulargewicht: 924.08
• MDL number: MFCD00877763
• UNSPSC Code: 41116107
• NACRES: NA.24

Eigenschaften

• 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

Beschreibung

General description

Find answers to frequently asked questions on USP products in USP FAQs.

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

This USP reference standard is intended for use in specified quality tests and assays.
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

These products are for test and assay use only. They are not meant for administration to humans or animals and cannot be used to diagnose, treat, or cure diseases of any kind.  ​

Other Notes

Sales restrictions may apply.

This product is part of the USP Biologics program.

This product is provided as delivered and specified by the issuing Pharmacopoeia. All information provided in support of this product, including SDS and any product information leaflets, has been developed and issued under the Authority of the issuing Pharmacopoeia. For further information and support please go to the website of the issuing Pharmacopoeia.

Sicherheitshinweise

• flash_point_f: Not applicable
• flash_point_c: Not applicable
• target_organs: Respiratory system
• pictograms: GHS07
• signalword: Warning
• hcodes: H315,H319,H335
• pcodes: P261 - P264 - P271 - P280 - P302 + P352 - P305 + P351 + P338
• Hazard Classifications: Eye Irrit. 2 - Skin Irrit. 2 - STOT SE 3
• Lagerklasse: 11 - Combustible Solids