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Merck
CN

PHR8528

NDIPA-D14

certified reference material, pharmaceutical secondary standard

Synonym(s):

N,N-di(propan-2-yl)nitrous amide, N-Isopropyl-N-nitrosoisopropylamine, DIPNA, NDIP

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About This Item

Empirical Formula (Hill Notation):
C6D14N2O
Molecular Weight:
144.27
UNSPSC Code:
12352200
NACRES:
NA.24

Key Documents

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grade

certified reference material, pharmaceutical secondary standard

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 methanol

application(s)

pharmaceutical

storage temp.

-10 to -25°C

Quality Level

300

Related Categories

General description

Deutero-N-Nitrosodiisopropylamine (NDIPA-d14)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

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.

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Danger

Hazard Classifications

Acute Tox. 3 Dermal - Acute Tox. 3 Inhalation - Acute Tox. 3 Oral - Carc. 1B - Flam. Liq. 2 - STOT SE 1

target_organs

Eyes,Central nervous system

Storage Class

3 - Flammable liquids

wgk

WGK 3

flash_point_f

49.5 °F - closed cup

flash_point_c

9.7 °C - closed cup

Regulatory Information

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Certificates of Analysis (COA)

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