Argatroban impurity 52

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For Research Use Only | Not For Clinical Use

CAT	APB02405
Synonyms	3-methylquinoline-5-sulfonic acid
Molecular Weight	223.25
Molecular Formula	C10H9NO3S

What is the synonym for Argatroban impurity 52?

The synonym for Argatroban impurity 52 is 3-methylquinoline-5-sulfonic acid.

What is the molecular weight of Argatroban impurity 52?

The molecular weight of Argatroban impurity 52 is 223.25.

What is the molecular formula of Argatroban impurity 52?

The molecular formula of Argatroban impurity 52 is C10H9NO3S.

Is Argatroban impurity 52 a pure substance?

No, Argatroban impurity 52 is an impurity, not a pure substance.

What is the significance of Argatroban impurity 52 in pharmaceutical manufacturing?

Argatroban impurity 52 is important in pharmaceutical manufacturing as it is a specific impurity that needs to be monitored and controlled to ensure the quality and safety of the drug product.

How is Argatroban impurity 52 detected in pharmaceutical formulations?

Argatroban impurity 52 can be detected using analytical techniques such as HPLC (High Performance Liquid Chromatography) or GC-MS (Gas Chromatography-Mass Spectrometry).

Why is it important to identify and characterize impurities like Argatroban impurity 52?

Identifying and characterizing impurities like Argatroban impurity 52 is important for quality control, regulatory compliance, and patient safety in pharmaceutical products.

Can Argatroban impurity 52 affect the efficacy of a drug product?

Yes, impurities like Argatroban impurity 52 can potentially affect the efficacy, stability, and safety of a drug product if present in significant amounts.

How can the level of Argatroban impurity 52 in a drug product be controlled during manufacturing?

The level of Argatroban impurity 52 in a drug product can be controlled through proper monitoring of raw materials, manufacturing processes, and storage conditions.

What steps can be taken to remove or reduce Argatroban impurity 52 during drug product development?

During drug product development, steps such as refining synthesis processes, optimizing purification techniques, and implementing stringent quality control measures can help remove or reduce impurities like Argatroban impurity 52.

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