Melphalan EP lmpurity B

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For Research Use Only | Not For Clinical Use

What is the name of the product?

The impurity is called Melphalan EP Impurity B.

What is the CAS number of Melphalan EP Impurity B?

The CAS number is 1259994-01-8.

What is the molecular weight of Melphalan EP Impurity B?

The molecular weight is 250.3.

What is the molecular formula of Melphalan EP Impurity B?

The molecular formula is C13H18N2O3.

Why is it important to identify and quantify impurities in pharmaceutical products?

It is important to ensure the safety, efficacy, and quality of the pharmaceutical products.

How can impurities affect the stability of a pharmaceutical product?

Impurities can catalyze reactions, cause degradation, and reduce the shelf life of the product.

What methods are commonly used to detect impurities in pharmaceutical products?

Methods such as HPLC, GC-MS, and NMR spectroscopy are commonly used.

How can impurities like Melphalan EP Impurity B be removed from a pharmaceutical product?

Impurities can be removed through purification processes like recrystallization or chromatography.

What are the regulatory requirements for impurities in pharmaceutical products?

Regulatory authorities like the FDA and EMA have guidelines on the acceptable limits of impurities in pharmaceutical products.

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