What Is the Identification & Assay of Active Ingredients?

Identification & Assay of Active Ingredients tests are fundamental physicochemical analyses conducted to verify the identity of active ingredients present in a product and to determine their quantities. These studies are of critical importance in assessing the quality, safety, and efficacy of pharmaceuticals, biocidal products, medical devices, cosmetic products, dietary supplements, and various chemical formulations.

The accurate identification of active ingredients and verification that they are present at target concentrations are fundamental requirements for ensuring that a product meets quality standards and complies with regulatory requirements.

At NanoTox, through our Physico-Chemical Test Unit, we offer active ingredient identification and quantification services using advanced analytical techniques and methods compliant with international standards.

Purpose of Identification & Assay Tests

These analyses aim to verify the identity of the active ingredients present in the product and determine their quantities.

Through these analyses:

• Active ingredient identity is verified,
• Active ingredient quantity is determined,
• Compliance with product specifications is evaluated,
• Consistency across batch series is ensured,
• Regulatory requirements are met.

The results obtained contribute to ensuring product quality and efficacy.

Why Are Active Ingredient Analyses Important?

A product’s ability to deliver its expected performance depends on the active ingredients being present in the correct amount and having the correct identity. Insufficient or excessive active ingredient content can pose risks to product efficacy and safety.

These analyses are widely applied, particularly for:

• Dosage verification in pharmaceutical products,
• Active ingredient control in biocidal products,
• Active ingredient analysis in medical device extracts,
• Ingredient verification in cosmetic products,
• R&D and product development studies

Analytical Techniques Used

At NanoTox laboratories, active ingredient analyses are performed using various analytical methods depending on the product’s characteristics and relevant regulatory requirements.

Commonly used techniques include:

• High-Performance Liquid Chromatography (HPLC)
• Gas Chromatography (GC)
• UV-Vis Spectrophotometry
• LC-MS/MS analyses
• ICP-OES and ICP-MS analyses
• Titrimetric methods

These methods ensure high accuracy, precision, and reproducibility.

Studies in Compliance with International Standards

The Identification & Assay of Active Ingredients studies conducted at NanoTox are carried out in accordance with relevant pharmacopoeias, international standards, and validation requirements.

Primary reference sources:

• International Council for Harmonisation (ICH) guidelines,
• European Pharmacopoeia (Ph. Eur.) monographs,
• United States Pharmacopeia (USP) monographs,
• Relevant product specifications and validation protocols.

This approach ensures that the results obtained meet internationally recognized quality standards.

Reliable Physicochemical Analyses with NanoTox

With its expert analytical chemistry team and advanced laboratory infrastructure, NanoTox performs Identification & Assay of Active Ingredients studies in accordance with international quality standards. We provide the reliable analytical data required for the development processes of pharmaceuticals, biocidal products, medical devices, and chemical products.

For detailed information about our “Identification & Assay of Active Ingredients” analyses and other physicochemical testing services, please contact NanoTox.