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Key Documents

1A00080

USP

3′-De(Dimethylamino)-3′-Oxoazithromycin

Pharmaceutical Analytical Impurity (PAI)

同義詞:

((2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-2-ethyl-3,4,10-trihydroxy-13-(((2R,4R,5S,6S)-5-hydroxy-4-methoxy-4,6- dimethyltetrahydro-2H-pyran-2-yl)oxy)-11-(((2S,6R)-3-hydroxy-6-methyl-4-oxotetrahydro-2H-pyran-2-yl)oxy)- 3,5,6,8,10,12,14-heptamethyl-1-oxa-6-azacyclopentadecan-15-one, (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6- Dideoxy-3,3-dimethyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6- trideoxy-3-oxo-ß-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one)

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About This Item

經驗公式(希爾表示法):
C36H65NO13
CAS號碼:
分子量::
719.90
分類程式碼代碼:
41116100
NACRES:
NA.24

等級

pharmaceutical analytical impurity (PAI)

agency

USP

API 家族

azithromycin

製造商/商標名

USP

應用

pharmaceutical

格式

neat

儲存溫度

2-8°C

一般說明

3′-De(Dimethylamino)-3′-Oxoazithromycin is a USP Pharmaceutical Analytical Impurity (PAI).

USP PAI are a product line of impurities suitable for research and analytical purposes, which help to ensure the quality and safety of medicines.

Associated Drug Substance: Azithromycin

Therapeutic Area: Antibiotics.

For more information about this PAI, visit here.

應用

3′-De(Dimethylamino)-3′-Oxoazithromycin (USP PAI) is intended for use in analytical testing to detect, identify, and measure pharmaceutical impurities.

特點和優勢

USP PAI advance your early analytical R&D and process development. PAI can be used in the following applications:
1. Conduct analytical tests during early formulation feasibility studies.
2. Determine degradation impurities produced during stress studies.
3. Develop, validate, and transfer analytical methods.
4. Perform spiking studies during process R&D to demonstrate depletion upon recrystallization.
5. Record retention times and/or spectra
6. Determine relative response factors.
7. Identify unknown impurities that formed during ICH stability conditions.
8. Identify impurities that are present in the Reference Listed Drug
9. Test for and profile impurities not listed in drug substance and drug product monographs.

分析報告

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.

其他說明

Sales restrictions may apply.

儲存類別代碼

11 - Combustible Solids

水污染物質分類(WGK)

WGK 3

閃點(°F)

Not applicable

閃點(°C)

Not applicable


分析證明 (COA)

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