1466652

N-Nitrosodiethylamine (NDEA)

United States Pharmacopeia (USP) Reference Standard

• 동의어(들): N-Ethyl-N-nitrosoethanamine, NDEA
• 실험식(Hill 표기법): C₄H₁₀N₂O
• CAS Number: 55-18-5
• Molecular Weight: 102.14
• MDL number: MFCD00013890
• UNSPSC 코드: 41116107
• NACRES: NA.24

속성

• 양식: liquid
• 포장: pkg of 1 mg
• 제조업체/상표: USP
• 응용 분야: pharmaceutical (small molecules)
• 형식: neat
• 저장 온도: −20°C
• SMILES string: N(N=O)(CC)CC
• InChI: 1S/C4H10N2O/c1-3-6(4-2)5-7/h3-4H2,1-2H3
• InChI key: WBNQDOYYEUMPFS-UHFFFAOYSA-N

설명

일반 설명

N-Nitrosodiethylamine is a carcinogenic compound that is strictly regulated within the biologics and pharmaceutical industries. Although not used as an ingredient, its presence is monitored in biologic products, as trace amounts can be toxic. NDEA is studied extensively for its potential health risks, and its detection is critical to ensuring the safety and regulatory compliance of biologic formulations.

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.

애플리케이션

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

It is also used to prepare standard, standard stock, nitrosamineRS stock, Nitrosamine standards stock solution mixture, and sensitivity stocksolutions to determine NDEA impurity in drug substances and drug products(valsartan, irbesartan, and losartan potassium etc.) by chromatography methodaccording to the general chapter <1469> of United States Pharmacopeia.

분석 메모

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.  

기타 정보

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.

안전성 정보

• 픽토그램: GHS02,GHS06,GHS08
• 신호어: Danger
• 유해 및 위험 성명서: H225,H301 + H311 + H331,H350,H370
• 예방조치 성명서: 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
• 표적 기관: 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