Erlotinib Impurity 65

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For Research Use Only | Not For Clinical Use

CAT	APB01897
Synonyms	2-amino-3,4-bis(2-methoxyethoxy)benzonitrile
Molecular Weight	266.29
Molecular Formula	C13H18N2O4

What is the molecular weight of Erlotinib Impurity 65?

The molecular weight of Erlotinib Impurity 65 is 266.29.

What is the molecular formula of Erlotinib Impurity 65?

The molecular formula of Erlotinib Impurity 65 is C13H18N2O4.

Is Erlotinib Impurity 65 also known by any other name?

Yes, it is also known as 2-amino-3,4-bis(2-methoxyethoxy)benzonitrile.

What is the chemical structure of Erlotinib Impurity 65?

The chemical structure of Erlotinib Impurity 65 is a benzonitrile derivative with two methoxyethoxy substitutions at the 3 and 4 positions.

What is the significance of Erlotinib Impurity 65 in pharmaceutical manufacturing?

Erlotinib Impurity 65 is important in pharmaceutical manufacturing as it is a known impurity in the production of Erlotinib, a drug used in cancer treatment.

How is Erlotinib Impurity 65 synthesized?

Erlotinib Impurity 65 is synthesized through a specific chemical reaction involving the introduction of amino and methoxyethoxy functional groups to the benzonitrile core.

What role does Erlotinib Impurity 65 play in quality control of Erlotinib drug products?

Erlotinib Impurity 65 serves as a reference standard for the identification and quantification of impurities present in Erlotinib drug products to ensure quality and purity.

How is Erlotinib Impurity 65 characterized in analytical testing?

Erlotinib Impurity 65 is characterized using techniques such as high-performance liquid chromatography (HPLC) and mass spectrometry to confirm its identity and purity.

Are there specific regulations or guidelines related to the presence of Erlotinib Impurity 65 in pharmaceutical products?

Yes, regulatory bodies like the FDA may have guidelines on the acceptable limits of Erlotinib Impurity 65 in Erlotinib drug products to ensure safety and efficacy.

What are the potential risks associated with elevated levels of Erlotinib Impurity 65 in pharmaceutical formulations?

Elevated levels of Erlotinib Impurity 65 in pharmaceutical formulations can potentially impact the efficacy and safety of the drug product, leading to adverse effects in patients.

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