1A00070

3′-(N,N-Didemethyl)Azithromycin; (Aminoazithromycin)

Pharmaceutical Analytical Impurity (PAI)

• Sinonimo/i: ((2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-11-(((2S,3R,4S,6R)-4-amino-3-hydroxy-6-methyltetrahydro-2H-pyran-2-yl)oxy)-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-1-oxa-6-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-amino-3,4,6-trideoxy-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6- azacyclopentadecan-15-one)
• Formula empirica (notazione di Hill): C₃₆H₆₈N₂O₁₂
• Numero CAS: 612069-27-9
• Peso molecolare: 720.93
• Codice UNSPSC: 41116100
• NACRES: NA.24

Proprietà

• Grado: pharmaceutical analytical impurity (PAI)
• agenzia: USP
• Famiglia di API: azithromycin
• Produttore/marchio commerciale: USP
• applicazioni: pharmaceutical
• Formato: neat
• Temperatura di conservazione: 2-8°C

Descrizione

Descrizione generale

3′-(N,N-Didemethyl)Azithromycin; (Aminoazithromycin) 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.

Applicazioni

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

Caratteristiche e vantaggi

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.

Risultati analitici

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.

Altre note

Sales restrictions may apply.

Informazioni sulla sicurezza

• Codice della classe di stoccaggio: 11 - Combustible Solids
• Classe di pericolosità dell'acqua (WGK): WGK 3
• Punto d’infiammabilità (°F): Not applicable
• Punto d’infiammabilità (°C): Not applicable