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PHR2408

N-Nitrosodiethylamine (NDEA)

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

N-Nitrosodiethylamine, Diethylnitrosamine

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About This Item

Linear Formula:
(C2H5)2NNO
CAS Number:
55-18-5
Molecular Weight:
102.14
NACRES:
NA.24
UNSPSC Code:
41116107
Beilstein/REAXYS Number:
1744991
MDL number:
MFCD00013890
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Quality Segment

300

grade

certified reference material, pharmaceutical secondary standard

agency

traceable to USP 1466652

form

liquid

CofA

current certificate can be downloaded

packaging

pkg of 1 g

bp

177 °C (lit.)

density

0.95 g/mL (lit.)

application(s)

pharmaceutical

storage temp.

2-30°C

SMILES string

CCN(CC)N=O

InChI

1S/C4H10N2O/c1-3-6(4-2)5-7/h3-4H2,1-2H3

InChI key

WBNQDOYYEUMPFS-UHFFFAOYSA-N

General description

Certified pharmaceutical secondary standards for application in quality control provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to in-house working standards.

Application

N-Nitrosodiethylamine (NDEA) pharmaceutical secondary referencestandard is used to determine NDEA impurity in:
  • Lisinopril API and its final product
  • Sitagliptin and metformin hydrochlorideimmediate and extended-release formulations
These Secondary Standards are qualified as Certified ReferenceMaterials. These are suitable for use in several analytical applicationsincluding but not limited to pharma release testing, pharma method developmentfor qualitative and quantitative analyses, food and beverage quality controltesting, and other calibration requirements.

Analysis Note

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

Other Notes

Find a digital Reference Material for this product available on our online platform ChemisTwin® for NMR. You can use this digital equivalent on ChemisTwin® for your sample identity confirmation and compound quantification (with digital external standard). An NMR spectrum of this substance can be viewed and an online comparison against your sample can be performed with a few mouseclicks. Learn more here and start your free trial.
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.
To see an example of a Certificate of Analysis for this material enter LRAC4356 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

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pictograms

Skull and crossbonesHealth hazard
GHS06,GHS08

signalword

Danger

Hazard Classifications

Acute Tox. 3 Oral - Aquatic Chronic 3 - Carc. 1B

Storage Class

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

flash_point_f

Not applicable

flash_point_c

Not applicable

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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