PHR2407

N-亚硝基二甲胺

Pharmaceutical Secondary Standard; Certified Reference Material

• 同義詞: 二甲基亚硝胺
• 線性公式: (CH₃)₂NNO
• CAS號碼: 62-75-9
• 分子量：: 74.08
• MDL號碼: MFCD00002053
• 分類程式碼代碼: 41116107
• NACRES: NA.24

屬性

• 等級: certified reference material; pharmaceutical secondary standard
• 品質等級: 300
• agency: traceable to USP 1466674
• 蒸汽壓力: 5 mmHg ( 20 °C)
• 形狀: liquid
• CofA: current certificate can be downloaded
• 包裝: pkg of 100 mg
• 折射率: n20/D 1.437 (lit.)
• bp: 153 °C/774 mmHg (lit.)
• 密度: 1.01 g/mL (lit.)
• 應用: pharmaceutical
• 儲存溫度: 2-8°C
• SMILES 字串: CN(C)N=O
• InChI: 1S/C2H6N2O/c1-4(2)3-5/h1-2H3
• InChI 密鑰: UMFJAHHVKNCGLG-UHFFFAOYSA-N

描述

一般說明

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.

應用

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

生化／生理作用

诱发大、小鼠出现胃癌、肝癌、肾癌和肺癌。

其他說明

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.

腳註

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.

安全資訊

• 象形圖: GHS06,GHS08,GHS09
• 訊號詞: Danger
• 危險聲明: H300 + H330,H350,H372,H411
• 防範說明: P202 - P260 - P264 - P271 - P273 - P304 + P340 + P310
• 危險分類: Acute Tox. 1 Inhalation - Acute Tox. 2 Oral - Aquatic Chronic 2 - Carc. 1B - STOT RE 1
• 標靶器官: Liver
• 儲存類別代碼: 6.1A - Combustible acute toxic Cat. 1 and 2 / very toxic hazardous materials
• 水污染物質分類（WGK）: WGK 3
• 閃點（°F）: 141.8 °F - closed cup
• 閃點（°C）: 61.0 °C - closed cup