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Merck
CN

1A02360

USP

PEMETREXED SODIUM 1-METHYL ESTER

Pharmaceutical Analytical Impurity (PAI)

Synonym(s):

Pemetrexed Sodium 1-Methyl Ester, ((S)-4-(4-(2-(2-amino-4-oxo-4,7-dihydro-3H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl)benzamido)-5-methoxy-5-oxopentanoic acid, sodium salt)

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About This Item

Empirical Formula (Hill Notation):
C21H23N5O6
CAS Number:
1265908-61-9
Molecular Weight:
441.44
MDL number:
MFCD24550141
UNSPSC Code:
12352200

Key Documents

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grade

pharmaceutical analytical impurity (PAI)

Agency

USP

manufacturer/tradename

USP

application(s)

pharmaceutical small molecule

format

neat

storage temp.

-10 to -25°C

Related Categories

General description

Pemetrexed Sodium 1-Methyl Ester 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: Pemetrexed


Therapeutic Area: Oncology

Application

Pemetrexed Sodium 1-Methyl Ester 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.
USP issued SDS can be found here

Pictograms

Health hazardExclamation mark
GHS08,GHS07

Signal Word

Danger

Hazard Statements

H315,H341,H360FD,H372

Hazard Classifications

Muta. 2 - Repr. 1A - Skin Irrit. 2 - STOT RE 1

Target Organs

Blood,Immune system,Testes

Storage Class Code

6.1C - Combustible acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Regulatory Information

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