API & Formulation

The Active ingredient in a pharmaceutical drug is known as the active pharmaceutical ingredient (API). The active pharmaceutical ingredient(API) provides a biologically active component to a drug product like a tablet, capsule, cream, injectable, etc that produces the intended effects in diagnosing, treating, treating, or preventing diseases. API produces a desired pharmacological effect and excipients’ … Read more

Potential impurities are substances that are formed during the reaction or already present in the form of starting materials, by-products, or intermediate products. Potential Impurities have no therapeutic value and are potentially harmful.  Therefore, they need to be controlled. Potential impurities may be arising due to: As per ICH Q3A defines potential impurities as those … Read more

A short review of Recent Control and Testing Strategies for Genotoxic impurities Analytical Method development and routine QC analysis for the determination of Genotoxic impurities (GI) at trace levels present exceptional challenges to pharmaceutical development and QC laboratories. These impurities are required to be controlled at trace levels in new drug substances and drug products. The International Conference … Read more

Impurities in pharmaceutical drug substances: Impurities are defined as a foreign particle that affects the purity of a substance. Usually, impurities occurring in many pharmaceutical or medicinal preparations may be of different types. Types of Impurities in pharmaceutical drug substances: According to the ICH, guideline impurities are classified as organic impurities, inorganic impurities, and residual solvents. Basically, Veeprho involves … Read more

Impurities in pharmaceuticals are unwanted chemicals that remain with the active pharmaceutical ingredients (APIs) or develop during formulation or upon aging of both API and formulation. In the pharmaceutical industry, an impurity is considered as any other inorganic or organic material, or residual solvents other than the drug substances, or ingredients, that arise out of … Read more

In the pharmaceutical industry, impurities may exist or develop in both API and formulation. The isolation, identification and quantification of these impurities are important for drug development and also for the regulatory requirement. The impurities present in APIs and finished products need impurity profiling to have control over quality. ICH (International Council for Harmonization) formulated … Read more

In pharmaceutical drug substances and drug products, impurities are developed during the synthesis. They remain with the active pharmaceutical ingredients (APIs) or sometimes develop during the formulation or upon the aging of both active pharmaceutical ingredients (API) and formulation of APIs to medicines. The consequences of impurities Impurities may bring about incompatibility with other substances; impurities may bring … Read more