PHR2408
N-Nitrosodiethylamine (NDEA)
Pharmaceutical Secondary Standard; Certified Reference Material
Synonym(s):
N-Nitrosodiethylamine, Diethylnitrosamine
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About This Item
grade
certified reference material
pharmaceutical secondary standard
Quality Level
Agency
traceable to USP 1466652
form
liquid
CofA
current certificate can be downloaded
packaging
pkg of 1 g
manufacturer/tradename
Manufactured by: Sigma-Aldrich Production GmbH, Switzerland
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
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General description
Application
- Lisinopril API and its final product
- Sitagliptin and metformin hydrochlorideimmediate and extended-release formulations
Analysis Note
Other Notes
Signal Word
Danger
Hazard Statements
Precautionary Statements
Hazard Classifications
Acute Tox. 3 Oral - Aquatic Chronic 3 - 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)
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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Articles
GC-MS method detects nitrosamines in Valsartan tablets, meeting US FDA guidelines for pharmaceutical quality control.
Discover the efficient separation six nitrosamine impurities with high reproducibility and precise detection to ensure accurate analysis for regulatory compliance.
亚硝胺经证是沙坦家族活性药物成分 (API) 中的一种严重污染物。本文介绍了一种根据美国 FDA 指南测定缬沙坦片中亚硝胺含量的 GC-MS 方法，适用于药品质量控制。
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