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PHR3610

Supelco

N-Nitrosomethylaminobutyric Acid (NMBA)

certified reference material, pharmaceutical secondary standard

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Synonym(s):
4-[Methyl(nitroso)amino]butanoic acid
Empirical Formula (Hill Notation):
C5H10N2O3
CAS Number:
61445-55-4
Molecular Weight:
146.14
UNSPSC Code:
41116107
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

300

Agency

traceable to USP 1466696

form

acetonitrile solution

CofA

current certificate can be downloaded

packaging

pkg of 1 mL

application(s)

pharmaceutical

InChI

1S/C5H10N2O3/c1-7(6-10)4-2-3-5(8)9/h2-4H2,1H3,(H,8,9)

InChI key

SJLBIPLIGYWGJV-UHFFFAOYSA-N

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General description

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.

Application

N-Nitrosomethylaminobutyric Acid (NMBA) pharmaceutical secondary reference standard is used for impurity analysis of NMBA in pharmaceutical formulations using supercritical fluid chromatography (SFC).

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, EP and BP 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

related product

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Description
Pricing

Pictograms

FlameExclamation mark
GHS02,GHS07

Signal Word

Danger

Hazard Classifications

Acute Tox. 4 Dermal - Acute Tox. 4 Inhalation - Acute Tox. 4 Oral - Eye Irrit. 2 - Flam. Liq. 2

WGK

WGK 2

Flash Point(F)

35.6 °F

Flash Point(C)

2.0 °C

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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Analytical lifecycle management for comprehensive and universal nitrosamine analysis in various pharmaceutical formulations by supercritical fluid chromatography
Schmidtsdorff, S et al.
Journal of Pharmaceutical and Biomedical Analysis, 197, 113960-113960 (2021)

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