等级
certified reference material
pharmaceutical secondary standard
质量水平
Agency
(Not traceable to any primary pharmacopeia standard)
CofA
current certificate can be downloaded
包装
pkg of 1.2 mL
浓度
1 mg/mL in methanol
应用
pharmaceutical
储存温度
-10 to -25°C
一般描述
Deutero-N-Nitrosodimethylamine (NDMA-d6) is a Certified Reference Material (CRM) to be used as internal standard for liquid chromatography-mass spectrometry (LC-MS) and gas chromatography-mass spectrometry (GC-MS) assays Each of our stable isotope labeled CRMs are rigorously tested for stability and isotopic purity.
Many nitrosamine impurities are known to be carcinogenic and of high concern for pharmaceutical development and production. Regulatory agencies such as FDA, EMA and ICH have applied strict regulatory guidelines for the control of these impurities to ensure patient safety.
Many nitrosamine impurities are known to be carcinogenic and of high concern for pharmaceutical development and production. Regulatory agencies such as FDA, EMA and ICH have applied strict regulatory guidelines for the control of these impurities to ensure patient safety.
分析说明
These secondary standards offer multi-traceability to the USP and EP primary standards, where they are available.
其他说明
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.
警示用语：
Danger
危险分类
Acute Tox. 3 Dermal - Acute Tox. 3 Inhalation - Acute Tox. 3 Oral - Carc. 1B - Flam. Liq. 2 - STOT SE 1
靶器官
Eyes,Central nervous system
储存分类代码
3 - Flammable liquids
WGK
WGK 3
闪点(°F)
49.5 °F - closed cup
闪点(°C)
9.7 °C - closed cup
法规信息
危险化学品
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