API Intermediates

Synthetic Impurities

During the synthesis of an API, various side reactions can occur, leading to the formation of unintended by-products. Apex Pharma supplies these synthesis impurities, which are vital in assessing the purity of the drug. These impurities may result from incomplete reactions or side reactions with reagents or solvents.

Examples: Unreacted intermediates, by-products formed during chemical processes, or impurities caused by the use of catalysts in the synthesis stage.

Degradation Impurities

APIs can degrade over time due to factors like light, temperature, and moisture exposure. Degradation can lead to the formation of impurities that could potentially reduce the drug’s potency or safety.

Apex Pharma offers degradation impurities such as those formed during oxidation, hydrolysis, photodegradation, or thermal degradation. These are important for testing the stability of the API under various conditions and assessing the shelf-life of the final drug product.

Examples: Oxidized compounds, hydrolysis products, or photodegraded impurities.

Residual Solvents

Residual solvents are trace amounts of solvents used in the production and purification of APIs. Apex Pharma supplies solvents that may remain in the final API or drug product. These solvents are closely monitored to ensure they do not exceed the allowable limits, as some solvents can be toxic if consumed in large quantities.

Examples: Acetone, methanol, dimethyl sulfoxide (DMSO), or ethyl acetate.

Process-Related Impurities

These impurities arise from the manufacturing process itself. In many cases, equipment, reagents, or conditions used during the production of APIs can introduce unwanted contaminants into the final product. Apex Pharma supplies these impurities, which can arise from:

Contaminants from manufacturing equipment: Impurities introduced by machines or tools used during synthesis or formulation.
Impurities from excipients: Inactive ingredients that could interact with the API during manufacturing.
Catalyst residues: Traces of catalysts used in chemical reactions during the synthesis process.

Isomeric Impurities

Isomers (structural or stereoisomers) of the API might also form as impurities during synthesis. These isomeric impurities can have different biological activities or potency compared to the intended API. Apex Pharma provides standards for isomeric impurities to ensure that they are detected and quantified accurately.

Examples: Geometric isomers or stereoisomers of the active ingredient.

Chiral Impurities

Many APIs are chiral (having two possible mirror-image forms, known as enantiomers). During the synthesis process, unwanted chiral impurities can arise if both enantiomers are present in a mixture when only one form is desired. Apex Pharma offers chiral impurities to help companies control and isolate the correct enantiomer.

Examples: R-isomer and S-isomer of chiral compounds