This product comes as 1 mL of solution in methanol, with an nominal N-Nitrosodibutylamine (NDBA) concentration of 1 mg/mL. The lot-specific concentration is reported on the certificate of analysis (CofA). For example, the CofA for Lot LRAD0174 reports a concentration of 990.8 micrograms per mL: https://www.sigmaaldrich.com/certificates/Graphics/COfAInfo/fluka/pdf/rtc/PHR3608_LRAD0174.pdf
PHR3608
N-Nitrosodibutylamine (NDBA)
certified reference material, pharmaceutical secondary standard
Synonym(s):
N-Butyl-N-nitroso-1-butanamine
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About This Item
Empirical Formula (Hill Notation):
C8H18N2O
CAS Number:
Molecular Weight:
158.24
UNSPSC Code:
41116107
NACRES:
NA.24
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SMILES string
N(N=O)(CCCC)CCCC
InChI
1S/C8H18N2O/c1-3-5-7-10(9-11)8-6-4-2/h3-8H2,1-2H3
InChI key
YGJHZCLPZAZIHH-UHFFFAOYSA-N
grade
certified reference material, pharmaceutical secondary standard
agency
traceable to USP 1466641
form
methanol solution
CofA
current certificate can be downloaded
packaging
pkg of 1 mL
manufacturer/tradename
Manufactured by: Sigma-Aldrich Production GmbH, Switzerland
application(s)
pharmaceutical
Quality Level
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1 of 4
This Item | PHR3607 | PHR3611 | PHR3610 |
|---|---|---|---|
| grade certified reference material, pharmaceutical secondary standard | grade certified reference material, pharmaceutical secondary standard | grade certified reference material, pharmaceutical secondary standard | grade certified reference material, pharmaceutical secondary standard |
| application(s) pharmaceutical | application(s) pharmaceutical | application(s) pharmaceutical | application(s) pharmaceutical |
| form methanol solution | form methanol solution | form methanol solution | form acetonitrile solution |
| agency traceable to USP 1466641 | agency traceable to USP 1466663 | agency traceable to USP 1466607 | agency traceable to USP 1466696 |
| CofA current certificate can be downloaded | CofA current certificate can be downloaded | CofA current certificate can be downloaded | CofA current certificate can be downloaded |
| packaging pkg of 1 mL | packaging pkg of 1 mL | packaging pkg of 1 mL | packaging pkg of 1 mL |
General description
Certified pharmaceutical secondary standards for application in quality control provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to in-house working standards.
Application
N-Nitrosodibutylamine (NDBA) pharmaceutical secondary reference standard is used for the determination of NDBA concentration in water samples via HPLC method in conjunction with a diode array detector.[1]
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.
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.
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.
Solvent
Description
1000 ug/mL solution in methanol
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Pricing
signalword
Warning
hcodes
Hazard Classifications
Acute Tox. 4 Oral - Carc. 2
Storage Class
12 - Non Combustible Liquids
wgk
WGK 3
flash_point_f
Not applicable
flash_point_c
Not applicable
Certificates of Analysis (COA)
Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.
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Evaluation of a method for the simultaneous quantification of N-nitrosamines in water samples based on stir bar sorptive extraction combined with high-performance liquid chromatography and diode array detection
Talebpour, Z et al.
Journal of Separation Science, 38, 1601-1609 (2015)
Articles
Discover the efficient separation six nitrosamine impurities with high reproducibility and precise detection to ensure accurate analysis for regulatory compliance.
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