PHR8525
NMBA-D3
certified reference material, pharmaceutical secondary standard
别名:
d3-4-[Methyl(nitroso)amino]butanoic acid
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
制造商/商品名称
Manufactured by: Sigma-Aldrich Production GmbH, Switzerland
浓度
1 mg/mL in acetonitrile
应用
pharmaceutical
储存温度
-10 to -25°C
一般描述
Deutero-N-Nitrosomethylaminobutyric Acid (NMBA-d3) 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
Stable Isotoped Labelled product intended for use as internal standard with mass spectrometry detection.
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. 4 Dermal - Acute Tox. 4 Inhalation - Acute Tox. 4 Oral - Eye Irrit. 2 - Flam. Liq. 2
储存分类代码
3 - Flammable liquids
WGK
WGK 2
闪点(°F)
35.6 °F
闪点(°C)
2.0 °C
法规信息
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