PHR2407

N-ニトロソジメチルアミン

Pharmaceutical Secondary Standard; Certified Reference Material

• 別名: ジメチルニトロソアミン
• 化学式: (CH₃)₂NNO
• CAS番号: 62-75-9
• 分子量: 74.08
• MDL番号: MFCD00002053
• UNSPSCコード: 41116107
• NACRES: NA.24

特性

• グレード: certified reference material; pharmaceutical secondary standard
• 品質水準: 300
• 認証: traceable to USP 1466674
• 蒸気圧: 5 mmHg ( 20 °C)
• 形状: liquid
• CofA: current certificate can be downloaded
• 包装: pkg of 100 mg
• 屈折率: n20/D 1.437 (lit.)
• bp: 153 °C/774 mmHg (lit.)
• 密度: 1.01 g/mL (lit.)
• アプリケーション: pharmaceutical
• 保管温度: 2-8°C
• SMILES記法: CN(C)N=O
• InChI: 1S/C2H6N2O/c1-4(2)3-5/h1-2H3
• InChI Key: UMFJAHHVKNCGLG-UHFFFAOYSA-N

詳細

詳細

This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. It is analyzed using GMP validated instruments as per pharmacopeia monograph methods and is traceable to Unites States Pharmacopeia (USP), European Pharmacopeia (EP), and British Pharmacopeia (BP) primary standards, wherever applicable.

It is provided with a comprehensive certificate of analysis (CoA) containing a certified purity value, calculated by the mass balance approach. All information regarding the use of this CRM can be found on the certificate of analysis.N-Nitrosodimethylamine (NDMA) is a nitrosamine that occurs as an impurity in sartan angiotensin II receptor blocker drugs.

アプリケーション

N-Nitrosodimethylamine CRM may also find uses as given below:

• Determination of N-Nitrosodimethylamine (NDMA) as an impurity in four valsartan APIs and tablets by high-performance liquid chromatography (HPLC)
• Quantitative analysis of NDMA in valsartan pharmaceutical formulations by capillary electrophoresis-nanospray-mass spectrometry
• Simultaneous determination of N-nitrosodimethylamine and N-nitrosomethylethylamine in drug substances and products containing sartans, ranitidine, and metformin by solid-phase extraction (SPE) and gas chromatography-tandem mass spectrometry (GC-MS/MS)
• Analysis of NDMA in the olmesartan API and tablets by high-performance liquid chromatography-mass spectrometry (HPLC-MS)
• Development and validation of an HPLC-MS/MS method for separation and quantification of NDMA impurity for quality control of ranitidine products

生物化学的／生理学的作用

マウスおよびラットにおける胃、肝、腎および肺がんを誘発します。

その他情報

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.

脚注

To see an example of a Certificate of Analysis for this material enter LRAC4355 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

安全性情報

• ピクトグラム: GHS06,GHS08,GHS09
• シグナルワード: Danger
• 危険有害性情報: H300 + H330,H350,H372,H411
• 注意書き: P202 - P260 - P264 - P271 - P273 - P304 + P340 + P310
• 危険有害性の分類: Acute Tox. 1 Inhalation - Acute Tox. 2 Oral - Aquatic Chronic 2 - Carc. 1B - STOT RE 1
• ターゲットの組織: Liver
• 保管分類コード: 6.1A - Combustible acute toxic Cat. 1 and 2 / very toxic hazardous materials
• WGK: WGK 3
• 引火点(°F): 141.8 °F - closed cup
• 引火点(℃): 61.0 °C - closed cup