What Is Residue & Impurity Quantification?

Residue & Impurity Quantification analyses are critical physicochemical tests conducted to detect and quantify residues, impurities, and undesirable components that may be present in products. These studies play a significant role in the quality and safety assessments of pharmaceuticals, medical devices, biocidal products, cosmetic products, raw materials, and various chemical formulations.

Low levels of impurities or residues may form in products due to production processes, raw materials, packaging materials, or storage conditions. Ensuring that these components remain within internationally accepted limits is of critical importance for product safety and regulatory compliance.

At NanoTox, within our Physico-Chemical Test Unit, we offer reliable residue and impurity analysis services using advanced analytical technologies and an infrastructure that adheres to GLP principles.

Purpose of Residue & Impurity Quantification Tests

These analyses aim to identify unwanted components in products and determine their quantities.

Bu çalışmalar sayesinde:

• Product purity is assessed,
• Residue levels are determined,
• Ürün güvenliği desteklenmektedir,
• Production processes are validated,
• Düzenleme gereksinimleri karşılanır.

The data obtained helps demonstrate that products comply with quality standards.

Why Are Residue and Impurity Analyses Important?

In addition to active ingredients, impurities or residues present at low levels can also have significant effects on product safety. While some impurities may reduce product efficacy, others may pose toxicological risks.

For this reason, residue and impurity analyses are widely applied, particularly in:

• Identifying degradation products in pharmaceutical products,
• Evaluating process residues in medical devices,
• Controlling production-related impurities in biocidal products,
• Identifying undesirable components in cosmetic products,
• And in raw material quality control studies.

Kullanılan Analitik Teknikler

At NanoTox laboratories, residue and impurity analyses are conducted using various analytical methods depending on the product structure and target analytes. Commonly used techniques include:

At NanoTox laboratories, residue and impurity analyses are performed using various analytical methods depending on the product structure and target analytes.

Commonly used techniques:

• High-Performance Sıvı Kromatografi (HPLC)
• Gaz Kromatografi (GC)
• LC-MS/MS analizleri
• GC-MS analyses
• ICP-MS analyses
• ICP-OES analyses
• UV-Vis Spectrophotometry

Thanks to these techniques, even components at very low concentrations can be detected with high sensitivity.

Studies in Compliance with International Guidelines and Regulations

Residue & Impurity Quantification analyses conducted at NanoTox are carried out in accordance with international standards and regulatory requirements specific to the relevant product group.

Temel referans kaynakları:

• ICH guidelines,
• Avrupa Pharmacopoeia (Ph. Eur.) monograflar,
• United States Pharmacopeia (USP) requirements,
• ISO standards,
• Product specifications and validation protocols.

This approach ensures that the results obtained are in compliance with internationally recognized quality criteria.

Parametreler Test Kapsamında Evaluated

Within the scope of Residue & Impurity Quantification studies:

• Organic impurities,
• Inorganic impurities,
• Process residues,
• Decomposition products,
• Solvent residues,
• Heavy metal residues,
• Product purity profile

değerlendirilir.

These analyses ensure that the quality and safety profiles of products are comprehensively established.

Reliable Residue and Impurity Analyses with NanoTox

NanoTox conducts Residue & Impurity Quantification analyses in accordance with international quality standards, leveraging its expert analytical chemistry team, advanced instrumentation infrastructure, and GLP-compliant operating system. We provide the reliable analytical data required for the development processes of pharmaceuticals, medical devices, biocidal products, and chemical products.

For detailed information about Residue & Impurity Quantification analyses and our other physicochemical testing services, please contact NanoTox.