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About This Item
Empirical Formula (Hill Notation):
C21H23NO5S
CAS Number:
Molecular Weight:
401.48
MDL number:
NACRES:
NA.24
UNSPSC Code:
41116107
grade
pharmaceutical analytical impurity (PAI)
agency
USP
API family
duloxetine
manufacturer/tradename
USP
application(s)
pharmaceutical small molecule
format
neat
storage temp.
-10 to -25°C
SMILES string
[s]1c(ccc1)[C@@H](Oc2c3c(ccc2)cccc3)CCN(C)C.OC(=O)C(=O)O, CN(C)CC[C@@H](C1=CC=CS1)OC2=CC=CC3=C2C=CC=C3.O=C(O)C(O)=O
InChI
1S/C19H21NOS.C2H2O4/c1-20(2)13-12-18(19-11-6-14-22-19)21-17-10-5-8-15-7-3-4-9-16(15)17;3-1(4)2(5)6/h3-11,14,18H,12-13H2,1-2H3;(H,3,4)(H,5,6)/t18-;/m0./s1
InChI key
GYUDMXKAVMKVPS-FERBBOLQSA-N
General description
N-Methyl Duloxetine Oxalate 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: Duloxetine
Therapeutic Area: Psychiatrics
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: Duloxetine
Therapeutic Area: Psychiatrics
Application
N-Methyl Duloxetine Oxalate (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.
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.
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Storage Class
11 - Combustible Solids
wgk
WGK 3
flash_point_f
Not applicable
flash_point_c
Not applicable
Regulatory Information
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Global Trade Item Number
| SKU | GTIN |
|---|---|
| Y0000754 | 04061837583711 |
| V800199-500G | 04061833000915 |
| 1043430500 | 04022536050225 |
| 1043439025 | 04022536892610 |
| 797979-500G | 04061822420731 |
| 797979-1KG | 04061832965819 |
| 15614-1KG | 04061838742476 |
| 15614-25KG | 04061833431511 |
| 1409003-500MG | 04061833851746 |
| 398160-250G | 04061835555079 |
| 55321-1G | 04061832582092 |
| 33233-1KG-R | 04061834411789 |
| 8187125000 | 04022536565958 |
| 8187121000 | 04022536443430 |
| 797979-250G | 04061832971612 |
| H11300-500G | 04061835253241 |
| H11300-25G | 04061833663929 |
| H11300-1KG | 04061835253227 |
| 15614-6X1KG | 04061833605479 |