Testing of human and veterinary medicinal products.
Testing of physical-chemical and microbiological (non-sterile) indicators of finished medicinal products for human and veterinary medicine and nutritional supplements, including hard capsules, soft capsules, chewing gums, matrices impregnated, liquids for external use, liquids for internal use and other solid dosage forms, semi-solids, suppositories, tablets, transdermal patches, veterinary premixes, and other non-sterile products.
All tests are performed according to the requirements of the current version of the European Pharmacopoeia or the registration dossier of the manufacturer/importer. When performing medicines initial batch control a “transfer method” for testing is needed. After successful completion of the transfer the medicinal products, subject to control, are included in our permit issued by the BDA. In implementing the above steps a routine monitoring of batches of medicinal products is possible to be carried out.
All tests of medicinal products or food supplements that are not subject to special authorization in BDA can be tested directly without a procedure of “transfer method” and registration in BDA.
1. Development and evaluation of analytical methods.
2. Determination of the following parameters: Identification and quantification of the active ingredient with a liquid and gas chromatography; Determination of related substances / impurities with liquid or gas chromatography ; Uniformity of dosage units – uniformity of mass and content uniformity; Determination of residual solvents by gas chromatography; Degree of dissolution of solid dosage forms and a subsequent determination by HPLC or UV / VIS spectrometry; Disintegration of the tablets; Determination of gastric resistance of tablets and capsules; density; viscosity; Reaction of the solution (pH); Mechanical strength of tablets; Water content by Karl Fischer method; Loss on drying; Abrasion of the tablet; Average tablet weight; Average volume of filling; Uniformity of the dose of multi-dose packaging; Identification of pigments; GC/MS identification; Stability in term of expiration date of medicinal products. Microbiological quality; other indicators in the European Pharmacopoeia.
We are equipped with air handling units with precise control of temperature and humidity in accordance with ICH Q1A ” Stability Testing of New Drug Substances and Products”.
3. Stability Studies
We perform stability testing of medicinal products and raw materials. Preparations are stored in high stability climate chambers under the following conditions:
• Long-term stability 25 ºC/60%RH
• Short-term stability 30 ºC/65%RH
• Accelerated stability 40 ºC/75%RH
• Stability in refrigerator (+2-8 ºC)
• Storage according to customer specifications
4. Analysis of raw materials used in the manufacture of medicines and food supplements
TC GLOBALTEST performs chemical analysis of raw materials used in the manufacture of medicines and food supplements , including: Measurement of trace metals by ICP-MS; Swabs and smears from surfaces and equipment ; Analysis of the purified water ; Testing of packaging for medicines and food supplements.