Active Ingredient Analyses for Biocidal Products: BPR Compliance and Nano-Test Solutions
Biocidal products are chemical or biological preparations used to kill, render harmless, or control harmful organisms. These products, which are classified into 22 different product types—ranging from disinfectants and pest control agents to wood preservatives and antifouling paints—exert their effect on the target organisms thanks to the active ingredients they contain. The correct identification of the active ingredient, the precise determination of its quantity, and verification of compliance with the specified specifications are of crucial importance both for regulatory authorities and for the safety of end users.
The Regulation on Biocidal Products issued by the Turkish Ministry of Health stipulates that the tests to be submitted as part of the application documentation for active ingredients and biocidal products must be conducted in accordance with international standards and the principles of Good Laboratory Practice (GLP). In the European Union, the guidance documents published by ECHA under the Biocidal Products Regulation (BPR – 528/2012) establish the framework for active ingredient testing.
Significance and Scope of Active Ingredient Analysis
The primary purpose of active ingredient analysis for biocidal products is to verify that the product conforms to its declared composition. These analyses are intended to provide answers to the following questions:
- Is the active ingredient listed on the product actually present?
- Does the concentration of the active ingredient match the value stated on the label and in the approval documents?
- Does the product contain any other undeclared active ingredients or harmful contaminants?
- Does the active ingredient remain stable throughout the product's shelf life?
Answering these questions using scientific methods forms the basis not only for the approval process but also for the product's evidential value during market inspections.
Selecting the Analytical Method Based on the Type of Active Ingredient
When classifying biocidal active ingredients according to their chemical functional groups, the choice of analytical method becomes clearer. Different groups—such as phenolic compounds, iodine-containing compounds, quaternary ammonium compounds, amine-based compounds, organometallic compounds, and peroxides—require different analytical approaches.
1. Non-volatile active ingredients: HPLC-DAD
For non-volatile active ingredients such as quaternary ammonium compounds (QACs), biguanides, and certain organic acids, high-performance liquid chromatography (HPLC) is the preferred method. When combined with a diode array detector (DAD), it can be used to perform both quantitative analyses and impurity profiling.
2. Volatile Compounds: GC-FID/ECD
Gas chromatography (GC) is used for alcohol-based disinfectants (isopropanol, ethanol) and certain volatile organic compounds. While the flame ionization detector (FID) allows for general quantification, the electron capture detector (ECD) offers high sensitivity for halogenated compounds.
3. Trace Analysis: LC-MS/MS and ICP-MS
LC-MS/MS (organic impurities) and ICP-MS (metal-based active ingredients and heavy metals) are used to analyze the impurity profile and residues in biocidal products. These techniques offer detection limits in the ppb range (parts per billion).
4. 5-Batch Analysis (Five Batches)
For the approval of an active pharmaceutical ingredient under the BPR, samples from at least five different batches must be analyzed to demonstrate the consistency of the manufacturing process. This analysis determines the purity of the active pharmaceutical ingredient, its impurity profile, and batch-to-batch variability.
Comparison of Analytical Methods for Biocidal Active Ingredients
The following table summarizes the basic methods used in the analysis of active ingredients in biocidal products:
| Analytical Method | Appropriate type of active ingredient | Detection limit | Scope of Application |
|---|---|---|---|
| HPLC-DAD | QACs, biguanides, organic acids | ppm range | Routine active ingredient determination, impurity profile |
| GC-FID | Alcohols, volatile organic compounds | ppm range | Determination of Active Ingredients in Disinfectants |
| GC-ECD | Halogenated compounds, pesticides | ppb range | Analysis of Active Ingredients at Trace Levels |
| LC-MS/MS | Polar and thermally unstable compounds | ppb-ppt range | Identification of Contaminants, Residue Analysis |
| ICP-MS | Metal-based active ingredients (silver, copper, zinc) | ppb range | Determination of Heavy Metals and Metallic Active Ingredients |
Active ingredient analyses under the BPR and national legislation
The approval of biocidal products involves a two-step process: first, the approval of the active ingredient, followed by the approval of the product containing that active ingredient. Active ingredient analyses play a crucial role in both phases.
Dossier for the Approval of an Active Substance (Active Substance Approval)
For an active ingredient to be approved under the BPR, technical equivalence must be demonstrated. In this context:
- The chemical identity and structure of the active ingredient are described.
- The degree of purity and the impurity profile are determined.
- A 5-batch analysis is performed using samples from at least five batches.
- The analytical methods are presented in their fully validated form.
Product Authorization Dossier
For product approval, it must be demonstrated that the active ingredient content in the finished product matches the specified value. In this context:
- The amount of active ingredient is determined in the finished product.
- Stability tests are conducted throughout the entire shelf life.
- Certificates of Analysis (CoA) are issued for each batch.
GLP-compliant analyses of active ingredients in biocidal products using Nano-Test
Active ingredient analyses form the basis for both the approval process and quality control for manufacturers of biocidal products. With its GLP-compliant analytical services, Nano-Test is a reliable solution partner for the biocidal industry in this area.
Nano-Test – Statement of Work
Nano-Test offers comprehensive services in the field of active ingredient analyses for biocidal products. In our laboratories, which are accredited according to GLP and ISO/IEC 17025, we perform analyses that fully comply with the requirements of the BPR (528/2012) and national regulations.
Our Service Portfolio:
- Determination of the amount of active ingredient: Precise quantification using HPLC-DAD, GC-FID/ECD, LC-MS/MS, and ICP-MS.
- 5-Batch Analysis: Technical equivalence studies for the active ingredient’s marketing authorization dossier.
- Contaminant Profile: Identification and quantification of relevant contaminants.
- Stability testing: Monitoring the stability of the active ingredient throughout its entire shelf life.
- Method development and validation: Validation studies in accordance with ICH Q2(R2) and Q14.
- Batch Analysis Certificates: Preparation of CoAs for each batch that are accepted by regulatory authorities.
All of our work is conducted in accordance with data integrity standards (ALCOA+ principles) and is submitted as GLP-compliant reports with audit approval.
Advantages of Nano-Test in the analysis of biocidal active ingredients:
- Wide range of active ingredients: Validated methods for QACs, alcohols, phenols, organometallic compounds, and more.
- BPR Compliance: Full compliance with the ECHA guidance documents and the BPR annexes.
- Fast Reporting: Results are delivered within 5–10 business days for standard analyses.
- A one-stop solution: active ingredient analysis, impurity profiling, and stability testing—all under one roof.
- Expert Team: A team with experience in biocidal legislation and analytical chemistry.
Active ingredient analyses for biocidal products are essential for ensuring the product’s safety, efficacy, and regulatory compliance. Conducting these analyses in accordance with the Biocidal Products Regulation (BPR) and national legislation—while adhering to GLP principles, using validated methods, and providing accurate reporting—is a prerequisite for the smooth progression of the authorization process.
With its advanced analytical infrastructure, GLP-certified processes, and expert staff, Nano-Test fully meets the active ingredient analysis requirements of biocidal product manufacturers. Have your active ingredient analyses performed by Nano-Test with its guarantee to ensure your products have seamless access to global markets.