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Abacavir Dinitroso Impurity
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  • New Jersey, USA
  • Czech Republic, EU
  • Mumbai, India

* Stock subject to availability.

Documentation

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Includes: HPLC, MASS/LC-MS, 1H NMR, FT-IR, Potency, Structure Elucidation Report (SER), and additional analytical data depending on the product.

Abacavir Dinitroso Impurity

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Catalogue No.:VE007759
CAS No.:N/A
Mol. Formula:C8H8N8O2
Mol. Weight:248.20 g/mol

Additional information on Abacavir Dinitroso Impurity

Parent drug

Abacavir

IUPAC Name

N-(2-amino-9-nitroso-9H-purin-6-yl)-N-cyclopropylnitrous amide

Pharmacopoeial Synonyms

N/A

Other Synonyms

ABCRC-1 Dinitroso Impurity

Smile

O=NN(C1=C2N=CN(N=O)C2=NC(N)=N1)C3CC3

InChI

InChI=1S/C8H8N8O2/c9-8-11-6-5(10-3-15(6)13-17)7(12-8)16(14-18)4-1-2-4/h3-4H,1-2H2,(H2,9,11,12)

Description

ABCRC-1 Dinitroso Impurity is an N-nitroso derivative of the secondary amine present in Abacavir | which is a highly characterized reference material that meets stringent regulatory standards set for nitrosamine compounds | including those set by USP | EMA | JP | and BP. This nitroso standard is essential for a variety of applications | such as analytical method development | method validation (AMV) | and Quality Control (QC) | particularly in the context of Abacavir production. It is suitable for use in both Abbreviated New Drug Applications (ANDA) and New Drug Applications (NDA). This nitrosamine standard helps establish detection limits | quantify impurity levels | and ensure trace nitroso impurities in pharmaceutical products remain within FDA and EMA safety limits.

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