To ensure the efficacy and safety of veterinary medicinal products, they must undergo comprehensive testing and analysis from the manufacturing process through market launch. In this process, we support you with physicochemical tests conducted in accordance with GLP standards (Good Laboratory Practice).
Why are physicochemical tests important?
The physical and chemical properties of active pharmaceutical ingredients and excipients in veterinary medicinal products can directly impact the stability, efficacy, and safety of the drug. Given this, physicochemical properties must be tested in accordance with international standards.
Importance of tests:
- Quality assurance,
- Ensuring correct dosage,
- Verification of stability and shelf life,
- Reduction of potential risks to animal health and the environment
are essential.
Physicochemical Tests in Accordance with GLP Standards
GLP is an international quality system that ensures the reliable, traceable, and transparent execution of all laboratory work. In this context, the following physicochemical tests are performed for veterinary medicinal products:
- Identification Tests: Detection of active ingredients and other components
- Purity Tests: Determination and limitation of potential impurities such as residues and degradation products within the product.
- Formulation-Specific Tests:
- Solubility/Disintegration Tests: Verification that medicinal products in tablet or capsule form dissolve within the body within an appropriate timeframe, ensuring active ingredient release.
- Suspension Characteristics: For products in suspension, homogeneity of particle distribution, sedimentation tendency, and re-suspension properties must be considered.
- Emulsion Characteristics: Emulsion preparations: phase separation, stability, droplet size, and homogeneity control.
- Tests for Injectable Preparations: Evaluation of critical quality parameters such as particulate contamination, pH, osmolality, sterility, and apyrogenicity in parenteral formulations.
- Tests for Topical Preparations: Control of properties such as viscosity, homogeneity, pH, and active ingredient distribution in products formulated as creams, ointments, gels, or sprays.
- Tests for Oral Liquids: Examination of appearance, pH, viscosity, homogeneity, and, if applicable, microbiological quality parameters in oral solutions and suspensions.
- Stability Tests: Determination of whether the product maintains its physical, chemical, and microbiological properties under various environmental conditions (temperature, humidity, light, etc.).
Benefits of GLP Application for Veterinary Medicinal Products
- Compliance with national and international legal regulations
- Acquisition of scientific data recognized in the approval process
- Documentation of product quality and safety
- Enhancement of market credibility
- Contribution to the protection of animal health