PHR2408

N-Nitrosodiethylamine (NDEA)

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonim(y): N-Nitrosodiethylamine, Diethylnitrosamine
• Wzór liniowy: (C₂H₅)₂NNO
• Numer CAS: 55-18-5
• Masa cząsteczkowa: 102.14
• NACRES: NA.24
• UNSPSC Code: 41116107
• Beilstein/REAXYS Number: 1744991
• MDL number: MFCD00013890
• eCl@ss: 25140904

Właściwości

• 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): cosmetics; food and beverages; 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

Opis

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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Informacja o środkach bezpieczeństwa

• Piktogramy: GHS06,GHS08
• Słowo ostrzegawcze: Danger
• Kody zagrożeń: H301,H350,H412
• Hazard Classifications: Acute Tox. 3 Oral - Aquatic Chronic 3 - Carc. 1B
• Klasa składowania: 6.1C - Combustible acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects
• Temperatura zapłonu (°F): Not applicable
• Temperatura zapłonu (°C): Not applicable
• Ostrzeżenia: P202 - P264 - P273 - P280 - P301 + P310 - P405