Key Documents

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

Name: 3′-(N,N-Didemethyl)-3′-N-Formylazithromycin
Brand: USP

Pharmaceutical Analytical Impurity (PAI)

Synonym(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)

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About This Item

Empirical Formula (Hill Notation):

C₃₇H₆₈N₂O₁₃

CAS Number:

765927-71-7

Molecular Weight:

748.94

MDL number:

MFCD00036336

NACRES:

NA.24

UNSPSC Code:

41116100

Pricing and availability is not currently available.

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Properties

grade

pharmaceutical analytical impurity (PAI)

agency

USP

API family

azithromycin

manufacturer/tradename

USP

application(s)

pharmaceutical

format

neat

storage temp.

2-8°C

Description

General description

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.

Application

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

Features and Benefits

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.

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.

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1 of 1

This Item	1A00080	1A00070	1A00840
USP 1A00210 3′-(N,N-Didemethyl)-3′-N-Formylazithromycin	USP 1A00080 3′-De(Dimethylamino)-3′-Oxoazithromycin	USP 1A00070 3′-(N,N-Didemethyl)Azithromycin; (Aminoazithromycin)	USP 1A00840 3′-Demethyl-3′-N-[(4-Methylphenyl)Sulfonyl]Azithromycin
grade pharmaceutical analytical impurity (PAI)	grade pharmaceutical analytical impurity (PAI)	grade pharmaceutical analytical impurity (PAI)	grade pharmaceutical analytical impurity (PAI)
manufacturer/tradename USP	manufacturer/tradename USP	manufacturer/tradename USP	manufacturer/tradename USP
application(s) pharmaceutical	application(s) pharmaceutical	application(s) pharmaceutical	application(s) pharmaceutical
format neat	format neat	format neat	format neat
API family azithromycin	API family azithromycin	API family azithromycin	API family azithromycin
storage temp. 2-8°C	storage temp. 2-8°C	storage temp. 2-8°C	storage temp. 2-8°C

Storage Class

11 - Combustible Solids

wgk

WGK 3

flash_point_f

Not applicable

flash_point_c

Not applicable

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Global Trade Item Number

SKU	GTIN
8007620100	04022536362311
8007621000	04022536362328
185361-100G	04061838757074
185361-5G	04061838757081
30-0320-5-500G-J	04061833411063
185361-500G	04061838339850
40818-100MG	04061831988512
1A00210-25MG	04065269093572

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