To ensure the effectiveness and safety of veterinary medicinal products, these must undergo comprehensive tests and analyses from the manufacturing process to market introduction. In this process, we support you with physical-chemical tests that are carried out according to the GLP standards (Good Laboratory Practice).
Why are physical-chemical tests important?
The physical and chemical properties of the active substances and excipients in veterinary medicinal products can directly affect the stability, efficacy and safety of the medicinal product. In this context, the physical-chemical properties must be tested according to international standards.
Significance of the tests:
- Quality assurance,
- Ensuring the correct dosage,
- Checking stability and shelf life,
- Reducing possible risks to animal health and the environment
are essential.
Physical-chemical tests according to GLP standards
GLP is an international quality system that ensures the reliable, traceable and transparent execution of all work in the laboratory. In this context, the following physical-chemical tests are carried out for veterinary medicinal products:
- Identification tests: Detection of active substances and other ingredients
- Purity tests: Determination and limitation of the content of potential impurities such as residues and decomposition products in the product.
- Formulation-specific tests:
- Solubility/disintegration tests: Determination of whether medicinal products in tablet or capsule form dissolve in the body within a reasonable time and ensure the release of the active substance.
- Suspension characteristics: For products in suspension, the homogeneity of the particle distribution, the tendency to sedimentation and the 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 particle contamination, pH value, osmolality, sterility and apyrogenicity in parenteral formulations.
- Tests for topical preparations: Control of properties such as viscosity, homogeneity, pH value and active substance distribution in products in the form of creams, ointments, gels or sprays.
- Tests for oral liquids: Examination of appearance, pH value, viscosity, homogeneity and, if necessary, microbiological quality parameters in oral solutions and suspensions.
- Stability tests: Determination of whether the product retains its physical, chemical and microbiological properties under various environmental conditions (temperature, humidity, light, etc.).
Advantages of GLP application in veterinary medicinal products
- Compliance with national and international regulations
- Obtaining scientific data that is recognized in the approval process
- Documentation of product quality and safety
- Increasing market credibility
- Contribution to the protection of animal health