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PHR2407

N-Nitrosodimethylamine (NDMA)

Pharmaceutical Secondary Standard; Certified Reference Material

Synonim(y):

N-Nitrosodimethylamine, NDMA, Dimethylnitrosamine

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Rozmiar/SKUDostępnośćCena netto
100 mg
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953,00 zł

Informacje o tej pozycji

Wzór liniowy:
(CH3)2NNO
Numer CAS:
Masa cząsteczkowa:
74.08
UNSPSC Code:
41116107
NACRES:
NA.24
MDL number:
eCl@ss:
25140904

953,00 zł


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Quality Segment

grade

certified reference material, pharmaceutical secondary standard

agency

traceable to USP 1466674

vapor pressure

5 mmHg ( 20 °C)

form

liquid

CofA

current certificate can be downloaded

packaging

pkg of 100 mg

refractive index

n20/D 1.437 (lit.)

bp

153 °C/774 mmHg (lit.)

density

1.01 g/mL (lit.)

application(s)

cosmetics
food and beverages
pharmaceutical

storage temp.

2-8°C

SMILES string

CN(C)N=O

InChI

1S/C2H6N2O/c1-4(2)3-5/h1-2H3

InChI key

UMFJAHHVKNCGLG-UHFFFAOYSA-N

General description

N-Nitrosodimethylamine (NDMA) is a nitrosamine that occurs as an impurity in sartan angiotensin II receptor blocker drugs.

This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. It is analyzed using Pharmacopeial compendial methods and/or validated methods, and is traceable to USP, EP standards where applicable.

It is provided with a comprehensive certificate of analysis (CoA) containing a certified purity value, calculated by the mass balance approach. All information regarding the use of this CRM can be found on the certificate of analysis.

Application

N-Nitrosodimethylamine CRM may also find uses as given below:

  • Determination of N-Nitrosodimethylamine (NDMA) as an impurity in four valsartan APIs and tablets by high-performance liquid chromatography (HPLC)
  • Quantitative analysis of NDMA in valsartan pharmaceutical formulations by capillary electrophoresis-nanospray-mass spectrometry
  • Simultaneous determination of N-nitrosodimethylamine and N-nitrosomethylethylamine in drug substances and products containing sartans, ranitidine, and metformin by solid-phase extraction (SPE) and gas chromatography-tandem mass spectrometry (GC-MS/MS)
  • Analysis of NDMA in the olmesartan API and tablets by high-performance liquid chromatography-mass spectrometry (HPLC-MS)
  • Development and validation of an HPLC-MS/MS method for separation and quantification of NDMA impurity for quality control of ranitidine products

Biochem/physiol Actions

Induces gastric, liver, kidney and lung cancer in mice and rats.

Other Notes

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.
To see an example of a Certificate of Analysis for this material enter LRAC4355 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.
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Ta pozycja
CRM40059486701466674
description

Pharmaceutical Secondary Standard; Certified Reference Material

description

certified reference material, 5000 μg/mL in methanol, ampule of 1 mL

description

certified reference material, 200 μg/mL in methanol

description

United States Pharmacopeia (USP) Reference Standard

grade

pharmaceutical secondary standard, certified reference material

grade

TraceCERT®, certified reference material

grade

TraceCERT®, certified reference material

grade

pharmaceutical primary standard

application(s)

cosmetics
food and beverages
pharmaceutical

application(s)

cleaning products
cosmetics
environmental
food and beverages
personal care

application(s)

cleaning products
cosmetics
environmental
food and beverages
personal care
pharmaceutical

application(s)

USP Biologics
pharmaceutical (small molecules)
pharmaceutical
pharmaceutical

form

liquid

form

-

form

-

form

liquid

vapor pressure

5 mmHg ( 20 °C)

vapor pressure

-

vapor pressure

-

vapor pressure

-

refractive index

n20/D 1.437 (lit.)

refractive index

-

refractive index

-

refractive index

-

agency

traceable to USP 1466674

agency

-

agency

EPA TO-7

agency

USP


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Słowo ostrzegawcze

Danger

Hazard Classifications

Acute Tox. 1 Inhalation - Acute Tox. 2 Oral - Aquatic Chronic 2 - Carc. 1B - STOT RE 1

Narządy docelowe

Liver

Klasa składowania

6.1A - Combustible acute toxic Cat. 1 and 2 / very toxic hazardous materials

Temperatura zapłonu (°F)

141.8 °F - closed cup

Temperatura zapłonu (°C)

61.0 °C - closed cup


Wykazy regulacyjne

Wykazy regulacyjne dotyczą głównie produktów chemicznych. Można w nich podawać ograniczoną liczbę informacji na temat produktów niechemicznych. Brak wpisu oznacza, że żaden ze składników nie znajduje się w wykazie. Użytkownik odpowiada za zagwarantowanie bezpiecznego i zgodnego z prawem stosowania produktu.

62-75-9

CAS No.


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Certyfikaty analizy (CoA)

Lot/Batch Number

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Questions

1–3 of 3 Questions  
  1. How can I determine the shelf life / expiration / retest date of this product?

    1 answer
    1. If this product has an expiration or retest date, it will be shown on the Certificate of Analysis (COA, CofA). If there is no retest or expiration date listed on the product's COA, we do not have suitable stability data to determine a shelf life. For these products, the only date on the COA will be the release date; a retest, expiration, or use-by-date will not be displayed.
      For all products, we recommend handling per defined conditions as printed in our product literature and website product descriptions. We recommend that products should be routinely inspected by customers to ensure they perform as expected.
      For products without retest or expiration dates, our standard warranty of 1 year from the date of shipment is applicable.
      For more information, please refer to the Product Dating Information document: https://www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/marketing/global/documents/418/501/product-dating-information-06-25-mk.pdf

      Helpful?

  2. How is shipping temperature determined? And how is it related to the product storage temperature?

    1 answer
    1. Products may be shipped at a different temperature than the recommended long-term storage temperature. If the product quality is sensitive to short-term exposure to conditions other than the recommended long-term storage, it will be shipped on wet or dry-ice. If the product quality is NOT affected by short-term exposure to conditions other than the recommended long-term storage, it will be shipped at ambient temperature. As shipping routes are configured for minimum transit times, shipping at ambient temperature helps control shipping costs for our customers. For more information, please refer to the Storage and Transport Conditions document: https://www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/marketing/global/documents/316/622/storage-transport-conditions-mk.pdf

      Helpful?

  3. I bought the PHR2407-100 mg product; however, I can not find information about the liquid in which it was dissolved. Can you please give me that information?

    1 answer
    1. This product is supplied as a neat or pure liquid that has not been diluted in a solvent or buffer. This compound has a density of 1.01 g/mL.

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