What are the sources of impurities in pharmaceutical products?

What are the sources of impurities in pharmaceutical products?

The various sources of impurity in pharmaceutical products are — reagents, heavy metals, ligands, catalysts, other materials like filter aids, charcoal, and the like, degraded end products obtained during \ after manufacturing of bulk drugs from hydrolysis, photolytic cleavage, oxidative degradation, decarboxylation.

What are pharmaceutical impurities?

Pharmaceutical impurities are the unwanted chemicals that remain with active. pharmaceutical ingredients (APIs) or drug product formulations. The impurities. observed in drug substances may arise during synthesis, or may be derived from.

How do you control impurities?

Impurities can be controlled by understanding the formation, fate and purge of the impurities during the manufacturing process. They also can be controlled by setting up appropriate controls at places where they either enter or form during the manufacturing process of drug substance and/ or drug product.

How pharmaceutical impurities can be identified?

Organic impurities come into existence during the synthesis of the active and inactive materials. They may occur during manufacturing or during storage of the materials. These impurities can be deduced from degradation reactions and ongoing synthesis in active pharmaceutical entities and drug products.

How are impurities introduced in chemical substances?

Impurities are either naturally occurring or added during synthesis of a chemical or commercial product. During production, impurities may be purposely, accidentally, inevitably, or incidentally added into the substance. The levels of impurities in a material are generally defined in relative terms.

Why iron is an impurity in pharmaceuticals?

d) Action of solvents and reagents on reaction vessels: During manufacturing process, some of the solvents and reagent may undergo reaction with metals of reaction vessel and may dissolve these metals, which appear as impurities in the final product. Example: ✓ Iron is known to contain Arsenic impurity.

What are organic impurities in pharmaceuticals?

Organic impurities [1-3] may arise during the manufacture or storage of new substance. They may be identified or unidentified, volatile or non-volatile; include starting materials, by-products, intermediates, degradation products, reagents, ligands and catalysts.

Which of the following method is used for characterization of impurities?

LC-MS was used for the characterization of impurities.

What is specified impurity?

Specified Impurity: An impurity that is individually listed and limited with a specific acceptance criterion in the new drug substance specification. A specified impurity can be either identified or unidentified.

What is the effect of impurities in pharmaceutical substances?

Impurities may bring about incompatibility with other substances. Impurities may lower the shelf life of the substances. Impurities may cause difficulties during formulations and use of the substances.