1032007

Amphotericin B

United States Pharmacopeia (USP) Reference Standard

• 실험식(Hill 표기법): C₄₇H₇₃NO₁₇
• CAS Number: 1397-89-3
• Molecular Weight: 924.08
• MDL number: MFCD00877763
• UNSPSC 코드: 41116107
• NACRES: NA.24

속성

• Grade: pharmaceutical primary standard
• API family: amphotericin b
• 양식: solid
• 제조업체/상표: USP
• 응용 분야: pharmaceutical (small molecule)
• 형식: neat
• 저장 온도: −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

설명

일반 설명

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.

애플리케이션

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

분석 메모

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.  ​

기타 정보

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.

Sales restrictions may apply.

안전성 정보

• 픽토그램: GHS08
• 신호어: Danger
• 유해 및 위험 성명서: H372
• 예방조치 성명서: P260 - P264 - P270 - P314 - P501
• Hazard Classifications: STOT RE 1
• Storage Class Code: 6.1C - Combustible acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects
• WGK: WGK 3
• Flash Point (°F): Not applicable
• Flash Point (°C): Not applicable