PHR3609

N-Nitrosoethylisopropylamine (NEIPA / NIPEA)

certified reference material, pharmaceutical secondary standard

• 同義詞: N-Ethyl-N-nitroso-2-propanamine, EIPNA, NEIPA
• 經驗公式（希爾表示法）: C₅H₁₂N₂O
• CAS號碼: 16339-04-1
• 分子量：: 116.16
• 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 1466685
• 形狀: methanol solution
• CofA: current certificate can be downloaded
• 包裝: pkg of 1 mL
• 應用: pharmaceutical
• 儲存溫度: -10 to -25°C
• InChI: 1S/C5H12N2O/c1-4-7(6-8)5(2)3/h5H,4H2,1-3H3
• InChI 密鑰: VGGZTNNNXAUZLB-UHFFFAOYSA-N

描述

一般說明

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.

應用

N-Nitrosoethylisopropylamine pharmaceutical secondary reference standard can be used for the determination of NEIPA impurity in valsartan products, via gas chromatography-tandem mass spectrometry.

These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.

分析報告

These secondary standards offer multi-traceability to the USP, EP and BP primary standards, where they are available.

其他說明

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.

溶劑

1000 ug/mL solution in methanol

安全資訊

• 象形圖: GHS08,GHS07
• 訊號詞: Danger
• 危險聲明: H302,H350
• 防範說明: P202 - P264 - P280 - P301 + P312 - P308 + P313 - P405
• 危險分類: Acute Tox. 4 Oral - Carc. 1B
• 儲存類別代碼: 6.1C - Combustible acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects
• 水污染物質分類（WGK）: WGK 3
• 閃點（°F）: 150.6 °F - (calculated)
• 閃點（°C）: 65.9 °C - (calculated)