1466674

N-Nitrosodimethylamine (NDMA)

United States Pharmacopeia (USP) Reference Standard

• Synonym(s): N-Methyl-N-nitrosomethanamine, NDMA
• Empirical Formula (Hill Notation): C₂H₆N₂O
• CAS Number: 62-75-9
• Molecular Weight: 74.08
• MDL number: MFCD00002053
• UNSPSC Code: 41116107
• NACRES: NA.24

Properties

• form: liquid
• packaging: pkg of 1 mg
• manufacturer/tradename: USP
• application(s): pharmaceutical (small molecules)
• format: single component solution (solution in methanol)
• storage temp.: −20°C
• SMILES string: N(N=O)(C)C
• InChI: 1S/C2H6N2O/c1-4(2)3-5/h1-2H3
• InChI key: UMFJAHHVKNCGLG-UHFFFAOYSA-N

Description

General description

N-Nitrosodimethylamine is another carcinogenic compound, with particular focus placed on its detection and control in biologic and pharmaceutical products. Like NDEA, NDMA can form as a by-product during manufacturing processes. Regulatory agencies require its rigorous monitoring, and it plays a key role in ensuring the purity and safety of biologic products.

The United States Pharmacopeia (USP) provides quality standards for biologics to ensure their safety, efficacy, and quality throughout the manufacturing process. These standards assist manufacturers in adhering to regulatory requirements and help safeguard public health by reducing risks associated with biologics.

This product is provided as delivered and specified by the USP Pharmacopoeia. For further information and support, including certificate/ product information sheets, please go to the website of the issuing Pharmacopoeia.

Application

N-Nitrosodimethylamine (NDMA) USP reference standard is intended for use only as specificallyprescribed in the United States Pharmacopoeia.

It is also used to prepare standard, standard stock, nitrosamine RS stock, nitrosamine standards stock solution mixture, and sensitivity stock solutions to determine NDMA impurity in drug substances and drug products(valsartan, irbesartan, and losartan potassium etc.) by chromatography method according to the general chapter 〈1469〉 of United States Pharmacopeia.

Analysis Note

These products are for test and assay use only. They are not meant for administration to humans or animals and cannot be used to diagnose, treat, or cure diseases of any kind.  

Other Notes

This product is part of USP Biologics Program.

This product is provided as delivered and specified by the USP Pharmacopoeia. For further information and support, including certificate/ product information sheets, please go to the website of the issuing Pharmacopoeia.

Sales restrictions may apply.

Safety Information

• Pictograms: GHS02,GHS06,GHS08
• Signal Word: Danger
• Hazard Statements: H225,H301 + H311 + H331,H350,H370
• Precautionary Statements: P201 - P210 - P280 - P301 + P310 - P303 + P361 + P353 - P304 + P340 + P311
• 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
• Storage Class Code: 3 - Flammable liquids
• WGK: WGK 3
• Flash Point(F): 49.5 °F
• Flash Point(C): 9.7 °C