1A00210

3′-(N,N-Didemethyl)-3′-N-Formylazithromycin

Pharmaceutical Analytical Impurity (PAI)

• Sinônimo(s): (N-((2S,4S,6R)-2-(((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)-3,5,6,8,10,12,14-heptamethyl-15-oxo-1-oxa-6-azacyclopentadecan11-yl)oxy)-3-hydroxy-6-methyltetrahydro-2H-pyran-4-yl)formamide), ((2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-Dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(formylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa6-azacyclopentadecan-15-one), (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-Dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3-formamido-3,4,6-trideoxy-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6- azacyclopentadecan-15-one)
• Fórmula empírica (Notação de Hill): C₃₇H₆₈N₂O₁₃
• Número CAS: 765927-71-7
• Peso molecular: 748.94
• Código UNSPSC: 41116100
• NACRES: NA.24

Propriedades

• grau: pharmaceutical analytical impurity (PAI)
• Agency: USP
• família API: azithromycin
• fabricante/nome comercial: USP
• aplicação(ões): pharmaceutical
• formato: neat
• temperatura de armazenamento: 2-8°C

Descrição

Descrição geral

3′-(N,N-Didemethyl)-3′-N-Formylazithromycin 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.

Aplicação

3′-(N,N-Didemethyl)-3′-N-Formylazithromycin (USP PAI) is intended for use in analytical testing to detect, identify, and measure pharmaceutical impurities.

Características e benefícios

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.

Nota de análise

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.

Outras notas

Sales restrictions may apply.

Informações de segurança

• Código de classe de armazenamento: 11 - Combustible Solids
• Classe de risco de água (WGK): WGK 3
• Ponto de fulgor (°F): Not applicable
• Ponto de fulgor (°C): Not applicable