PHR2408

N-Nitrosodiethylamine (NDEA)

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): N-Nitrosodiethylamine, Diethylnitrosamine
• Linear Formula: (C₂H₅)₂NNO
• CAS Number: 55-18-5
• Molecular Weight: 102.14
• Beilstein/REAXYS Number: 1744991
• MDL number: MFCD00013890
• UNSPSC Code: 41116107
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• 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

Description

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-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, 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.

Footnote

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.

Recommended products

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.

Safety Information

• pictograms: GHS06,GHS08
• signalword: Danger
• hcodes: H301,H350,H412
• pcodes: P202 - P264 - P270 - P273 - P280 - P301 + P310
• 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
• wgk_germany: WGK 3
• flash_point_f: Not applicable
• flash_point_c: Not applicable