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Merck

PHR2408

Supelco

N-ニトロソジエチルアミン

Pharmaceutical Secondary Standard; Certified Reference Material

別名:

ジエチルニトロソアミン

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About This Item

化学式:
(C2H5)2NNO
CAS番号:
分子量:
102.14
Beilstein:
1744991
MDL番号:
UNSPSCコード:
41116107
NACRES:
NA.24

グレード

certified reference material
pharmaceutical secondary standard

品質水準

認証

traceable to USP 1466652

形状

liquid

CofA

current certificate can be downloaded

包装

pkg of 1 g

bp

177 °C (lit.)

密度

0.95 g/mL (lit.)

アプリケーション

pharmaceutical

保管温度

2-30°C

SMILES記法

CCN(CC)N=O

InChI

1S/C4H10N2O/c1-3-6(4-2)5-7/h3-4H2,1-2H3

InChI Key

WBNQDOYYEUMPFS-UHFFFAOYSA-N

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詳細

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.

アプリケーション

N-Nitrosodiethylamine (NDEA) pharmaceutical secondary referencestandard is used to determine NDEA impurity in:
  • Lisinopril API and its final product
  • Sitagliptin and metformin hydrochlorideimmediate and extended-release formulations
These Secondary Standards are qualified as Certified ReferenceMaterials. These are suitable for use in several analytical applicationsincluding but not limited to pharma release testing, pharma method developmentfor qualitative and quantitative analyses, food and beverage quality controltesting, and other calibration requirements.

アナリシスノート

These secondary standards offer multi-traceability to the USP, EP and BP primary standards, where they are available.

その他情報

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.

脚注

To see an example of a Certificate of Analysis for this material enter LRAC4356 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

おすすめ製品

Find a digital Reference Material for this product available on our online platform ChemisTwin® for NMR. You can use this digital equivalent on ChemisTwin® for your sample identity confirmation and compound quantification (with digital external standard). An NMR spectrum of this substance can be viewed and an online comparison against your sample can be performed with a few mouseclicks. Learn more here and start your free trial.

ピクトグラム

Skull and crossbonesHealth hazard

シグナルワード

Danger

危険有害性情報

危険有害性の分類

Acute Tox. 3 Oral - Aquatic Chronic 3 - Carc. 1B

保管分類コード

6.1C - Combustible acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects

WGK

WGK 3

引火点(°F)

Not applicable

引火点(℃)

Not applicable


適用法令

試験研究用途を考慮した関連法令を主に挙げております。化学物質以外については、一部の情報のみ提供しています。 製品を安全かつ合法的に使用することは、使用者の義務です。最新情報により修正される場合があります。WEBの反映には時間を要することがあるため、適宜SDSをご参照ください。

労働安全衛生法名称等を表示すべき危険物及び有害物

名称等を表示すべき危険物及び有害物

労働安全衛生法名称等を通知すべき危険物及び有害物

名称等を通知すべき危険物及び有害物

Jan Code

PHR2408-1G:


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試験成績書(COA)

Lot/Batch Number

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If you require a particular version, you can look up a specific certificate by the Lot or Batch number.

以前この製品を購入いただいたことがある場合

文書ライブラリで、最近購入した製品の文書を検索できます。

文書ライブラリにアクセスする

Development and Validation of an HPLC-FLD Method for the Determination of NDMA and NDEA Nitrosamines in Lisinopril Using Pre-Column Denitrosation and Derivatization Procedure
Tsanaktsidou, et al
Separations, 9, 347-347 (2022)
Development and validation of rapid ultra high performance liquid chromatography with tandem mass spectroscopic method for the quantification of N-nitrosodimethyl amine and N-nitrosodiethyl amine in sitagliptin and metformin hydrochloride immediate and extended-release formulations
Mallavarapu, et al.
Journal of Separation Science, 45, 3067-3081 (2022)

資料

Discover the efficient separation six nitrosamine impurities with high reproducibility and precise detection to ensure accurate analysis for regulatory compliance.

GC-MS method detects nitrosamines in Valsartan tablets, meeting US FDA guidelines for pharmaceutical quality control.

関連コンテンツ

Accurately detect and quantify trace nitrosamines (NDMA, NDEA, NEIPA, NDIPA, NDBA, etc.) in pharmaceutical drugs using our complete product portfolio and application guides for LC-MS and GC-MS. Order high-quality reference standards, columns, filters & more.

ライフサイエンス、有機合成、材料科学、クロマトグラフィー、分析など、あらゆる分野の研究に経験のあるメンバーがおります。.

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