Impurities are typically classified into organic impurities, inorganic impurities, and residual solvents. Each category requires different methods of identification and control.

Elemental impurities, such as heavy metals, can be toxic even in trace amounts. Regulatory guidelines require their levels to be monitored and controlled to ensure patient safety.

Molkem collaborates with leading elemental impurities suppliers and chemical impurities suppliers to ensure that all distributed impurities meet stringent global standards for purity and consistency.

API impurities are contaminants found in active pharmaceutical ingredients. These impurities must be identified, quantified, and controlled to meet regulatory standards and ensure drug safety.

Advanced analytical techniques like HPLC, GC-MS, and ICP-MS are used to detect and quantify impurities in pharmaceutical products, ensuring compliance with regulatory requirements.

Guidelines from organizations like the ICH and FDA dictate the acceptable levels and types of impurities in pharmaceuticals, including specified, unspecified, and total impurity levels.

Controlling impurities during formulation is essential to maintain the stability, efficacy, and safety of the final pharmaceutical product.

Challenges include identifying unknown impurities, controlling impurities at trace levels, and ensuring compliance with evolving regulatory standards.

Molkem provides technical support and comprehensive data packages to help clients identify, control, and manage impurities in pharmaceutical chemistry, ensuring compliance and product safety.