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Key Documents

PHR3609

Supelco

N-Nitrosoethylisopropylamine (NEIPA / NIPEA)

certified reference material, pharmaceutical secondary standard

Synonym(s):

N-Ethyl-N-nitroso-2-propanamine, EIPNA, NEIPA

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About This Item

Empirical Formula (Hill Notation):
C5H12N2O
CAS Number:
16339-04-1
Molecular Weight:
116.16
UNSPSC Code:
41116107
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

300

Agency

traceable to USP 1466685

form

methanol solution

CofA

current certificate can be downloaded

packaging

pkg of 1 mL

application(s)

pharmaceutical

storage temp.

-10 to -25°C

InChI

1S/C5H12N2O/c1-4-7(6-8)5(2)3/h5H,4H2,1-3H3

InChI key

VGGZTNNNXAUZLB-UHFFFAOYSA-N

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General description

Pharmaceutical secondary standards for application in quality control provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards.

Application

N-Nitrosoethylisopropylamine pharmaceutical secondary reference standard can be used for the determination of NEIPA impurity in valsartan products, via gas chromatography-tandem mass spectrometry.

These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.

Analysis Note

These secondary standards offer multi-traceability to the USP, EP and BP 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.

Solvent

Description
    1000 ug/mL solution in methanol

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Product No.
Description
Pricing

Pictograms

Health hazardExclamation mark
GHS08,GHS07

Signal Word

Danger

Hazard Statements

H302,H350

Hazard Classifications

Acute Tox. 4 Oral - Carc. 1B

Storage Class Code

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

WGK

WGK 3

Flash Point(F)

150.6 °F - (calculated)

Flash Point(C)

65.9 °C - (calculated)

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Certificates of Analysis (COA)

Lot/Batch Number
LRAD8749
LRAD0175
LRAD0175

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Development of GC-MS/MS Method for Simultaneous Estimation of Four Nitrosoamine Genotoxic Impurities in Valsartan
Rao T, et al.
Turkish Journal of Pharmaceutical Sciences, 19, 455-455 (2022)

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