Polymorphic Impurities: Risk Assessment & Investigation

 

Introduction

Polymorphism arises when a solid compound present in two or more crystal forms. If polymorphic impurities or anything else other than the predicted crystalline forms is present in a drug substance of a pharmaceutical product, it may impact the performance, quality, safety, efficacy, and stability of the drug product. Different polymorphic forms can have different melting points, spectral properties, and thermodynamic stability. Amorphous

Assessment of Risk to the Quality of Drug Substance and Drug Product

Polymorphs are one type of solid form. Other solid form types include solvates, hydrates, and amorphous forms. Many organic and inorganic compounds, including drug substances, can exist in multiple solid forms. In the manufacturing of drug substance, polymorphism of crystals must be strictly controlled, because it significantly affects the bio-availability of a drug Impurity is one of the important aspects in control of crystal polymorphism.

Polymorphism is regularly affected by a trace number of impurities. Many drug substances are synthesized through many reactions. It is significant to know the impact of the impurities in the presence of crystal polymorphs.

Crystallization from different solvents may give rise to different crystal forms or solvates. Excessive humidity or heat are the most visible cause of polymorphism. Changes in polymorphism can also be induced as a significance of numerous common stages of drug substance processing such as granulation, melting, spray drying, compression, and milling that are required to produce the final dosage form.

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