PHR8528
NDIPA-D14
certified reference material, pharmaceutical secondary standard
别名:
N,N-di(propan-2-yl)nitrous amide, N-Isopropyl-N-nitrosoisopropylamine, DIPNA, NDIP
grade
certified reference material, pharmaceutical secondary standard
agency
((Not traceable to any primary pharmacopeia standard))
CofA
current certificate can be downloaded
packaging
pkg of 1.2 mL
manufacturer/tradename
Manufactured by: Sigma-Aldrich Production GmbH, Switzerland
concentration
1 mg/mL in methanol
application(s)
pharmaceutical
storage temp.
-10 to -25°C
Quality Level
General description
Deutero-N-Nitrosodiisopropylamine (NDIPA-d14)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.
Analysis Note
These secondary standards offer multi-traceability to the USP and EP primary standards, where they are available.
Other Notes
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.
signalword
Danger
Hazard Classifications
Acute Tox. 3 Dermal - Acute Tox. 3 Inhalation - Acute Tox. 3 Oral - Carc. 1B - Flam. Liq. 2 - STOT SE 1
target_organs
Eyes,Central nervous system
存储类别
3 - Flammable liquids
wgk
WGK 3
flash_point_f
49.5 °F - closed cup
flash_point_c
9.7 °C - closed cup
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