Biological Activity and Stability Analyses

Frequently Asked Questions

• What is Biological Activity Analysis?

  Biological activity analysis measures the intended effect of pharmaceuticals, biocidal, and cosmetic products. It verifies that the product is effective and safe for its intended use.

• What is Stability Analysis?

  Stability analysis monitors chemical, physical, and biological changes in products over their shelf life, ensuring safety and efficacy.

• Why Are Biological Activity Tests Important?

  They confirm that products deliver the intended effect and are safe for users. Ineffective products can pose health risks and legal issues.

• Which Products Require These Tests?

  Pharmaceuticals, biocidal products, cosmetics, personal care items, and some dietary supplements undergo biological activity and stability testing.

• What Parameters Are Measured?

  Biological activity tests assess antimicrobial activity, enzyme activity, cellular responses, and toxicity. Stability tests monitor chemical degradation, color, odor, and pH changes.

• How Are Analyses Conducted?

  Biological activity tests use in vitro cell studies, microorganism assays, and biochemical methods. Stability tests simulate temperature, light, and humidity conditions.

• Why Are Efficacy Tests Critical for Health?

  Products that fail to deliver intended effects or are toxic pose health risks. Testing ensures safe and effective product use.

• How Do Stability Tests Affect Shelf Life?

  If a product loses efficacy, safety and performance decline. Stability tests define proper storage and expiration dates.

• How Long Do Tests Take?

  Biological activity tests: 3–7 days. Stability tests: 1–12 weeks depending on product and conditions.

• Are These Tests Legally Required?

  Yes. For biocidal, cosmetic, and pharmaceutical products, tests are mandatory, with accredited lab reports providing official documentation.

• How Are Samples Prepared?

  Samples are delivered under sterile and proper conditions. Amount depends on product type and test requirements.

• How Do Reports Help Businesses?

  Reports certify product safety and efficacy and support quality control, regulatory inspections, exports, and product development.

• How Are Prices Determined?

  Prices depend on test type, sample number, analysis duration, and scope. Comprehensive tests may cost more but are critical for compliance.

• Difference Between In Vitro & In Vivo Methods

  In vitro uses lab cell models; in vivo uses live organisms. In vitro is faster and often more ethical.

• Advantages of Accredited Laboratories

  ISO/IEC 17025 accredited labs deliver reliable, legally valid results. Reports are critical for export and certification processes.