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Merck
CN

PHR8525

Supelco

NMBA-D3

certified reference material, pharmaceutical secondary standard

Synonym(s):

d3-4-[Methyl(nitroso)amino]butanoic acid

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About This Item

Empirical Formula (Hill Notation):
C5H7D3N2O3
CAS Number:
1184996-41-5
Molecular Weight:
149.16
UNSPSC Code:
12352200

Key Documents

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grade

certified reference material
pharmaceutical secondary standard

Quality Level

300

Agency

(Not traceable to any primary pharmacopeia standard)

CofA

current certificate can be downloaded

packaging

pkg of 1.2 mL

manufacturer/tradename

Manufactured by: Sigma-Aldrich Production GmbH, Switzerland

concentration

1 mg/mL in acetonitrile

application(s)

pharmaceutical

storage temp.

-10 to -25°C

Related Categories

General description

Deutero-N-Nitrosomethylaminobutyric Acid (NMBA-d3) is a Certified Reference Material (CRM) to be used as internal standard for liquid chromatography-mass spectrometry (LC-MS) and gas chromatography-mass spectrometry (GC-MS) assays Each of our stable isotope labeled CRMs are rigorously tested for stability and isotopic purity.

Many nitrosamine impurities are known to be carcinogenic and of high concern for pharmaceutical development and production. Regulatory agencies such as FDA, EMA and ICH have applied strict regulatory guidelines for the control of these impurities to ensure patient safety.

Analysis Note

These secondary standards offer multi-traceability to the USP and EP primary standards, where they are available.

Other Notes

Stable Isotoped Labelled product intended for use as internal standard with mass spectrometry detection.
This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.

Pictograms

FlameExclamation mark
GHS02,GHS07

Signal Word

Danger

Hazard Classifications

Acute Tox. 4 Dermal - Acute Tox. 4 Inhalation - Acute Tox. 4 Oral - Eye Irrit. 2 - Flam. Liq. 2

Storage Class Code

3 - Flammable liquids

WGK

WGK 2

Flash Point(F)

35.6 °F

Flash Point(C)

2.0 °C

Regulatory Information

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Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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