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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