Pharmaceutical analysis

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Testing of medicinal products for human and veterinary medicine

Testing center Globaltest has been testing medicinal products for human and veterinary medicine since 2006. To date, we have tested about 260 individual active ingredients in the form of substances or finished medicinal products.

Tests on physicochemical and microbiological (non-sterile) parameters of finished medicinal products for human and veterinary medicine, including hard capsules, soft capsules, gums, impregnated matrices, liquids for external use, liquids for internal use, other solid dosage forms, semi-solid forms, suppositories, tablets, transdermal patches, veterinary premixes, and other non-sterile medicinal products.

All tests are performed according to the requirements of the current version of the European Pharmacopoeia or the registration file of the manufacturer/importer

Performing analyses of physicochemical and microbiological (non-sterile) indicators of finished medicinal products for human and veterinary medicine can only be commissioned by:

– The manufacturer of a medicinal product;
– Marketing Authorization Holder (MAH) in possession of the relevant product dossier containing the Specification and Analytical Methods;
– Qualified persons releasing the medicinal product for the relevant market;

In connection with the above, natural persons who have purchased medicinal products from a pharmacy or elsewhere cannot commission analyses.

All tests of medicinal products that are not subject to a special permit regime in a drug authority agency can be tested directly, without carrying out a “method transfer” procedure and registration in a drug authority agency

Offered services:

1. Types of tests

Spectral and chromatographic analyses

  • dentification of active ingredients;
  • Assay with liquid and gas chromatography or UV/VIS spectrometry;
  • Determination of related substances/impurities with liquid or gas chromatography;
  • Uniformity of the dosage units
  • Uniformity of mass and uniformity of content;
  • Dissolution of solid dosage forms and subsequent determination by liquid chromatography or UV/VIS spectrometry;
  • Determination of residual solvents by gas chromatography;
  • R identifications;
  • GC/MS identifications;
  • LC/MS identifications;
  • Gas chromatographic profile;
  • Determination of melting point.

Pharmaceutical analyses

  • Disintegration;
  • Hardness;
  • Friability;
  • Average weight; Average filling volume; Average mass of the contents;
  • Uniformity of dosage units of multi-dose packages;

Physicochemical analyses

  • Assay by titration methods – classical and potentiometric;
  • Density;
  • pH reaction;
  • Water content according to Karl Fischer;
  • Loss on drying;
  • Sulfated ash; Ash, insoluble in hydrochloric acid;
  • Heavy metals – quantification by ICP-MS;
  • Identification of colorants by qualitative/color reactions or Thin Layer Chromatography
  • Identification by determination of melting point
  • Other physicochemical analyses, according to monographs of the European Pharmacopoeia

Microbiological analyses (non-sterile)

  • Microbiological quality of non-sterile medicinal products and substances – TAMC, TYMC, Specified microorganisms
  • PET (preservative efficacy test) – IC Globaltest offers tests to prove the antimicrobial efficacy of medicinal products. The performance of the tests is based on Ph.Eur, USP or criteria specified by the client.

Attention: Microbiological indicators of medicinal products (TAMC, TYMC and pathogenic microorganisms) are determined according to Ph.Eur. and/or product registration dossier. Service prices are determined on a case-by-case basis and differ from food analysis.

2. Analytical method transfer. Development, validation, and verification of methods

When carrying out the initial control of batches of medicinal products, it is necessary to carry out an “analytical method transfer” (AMT) between the manufacturer’s laboratory and Testing center Globaltest. It is permissible to perform the routine control of a medicinal product batch in parallel with the analytical method transfer. Performing an analytical method transfer is a mandatory step when initially commissioning analyses. In case the contracting party is unable to organize the analytical transfer of the methods, upon initial assignment of the analyses, the laboratory offers verification and/or validation of the physicochemical indicators from the registration file of the medicinal product. The conditions under which the service is performed are offered and negotiated individually for each product.

Testing center Globaltest offers the development and validation of microbiological and chemical methods for testing finished medicinal products or substances, according to the client’s criteria.

3. Storage and stability tests

Testing center Globaltest offers storage and/or stability testing of products according to their Shelf life specifications.
We are equipped with climatic chambers and offer storage under the following conditions:

  • Long-term stability 25 ºC/ 60% RH;
  • Short-term stability 30 ºС/ 65% RH;
  • Accelerated stability 40 °C/ 75% RH;
  • Stability in a refrigerator (2 – 8 ºC);
  • Photostability;
  • Storage under conditions according to customer requirements

4. Dissolution profiles

Testing center Globaltest offers and often performs Dissolution profiles, in which the results for Assay are compared for different Dissolution setups. Such analyses include the preparation and execution of the Dissolution indicator, in which different variations of analyses are possible, such as:

  1. Dissolution with different Dissolution media on the same batch of a medicinal product;
  2. Dissolution in extended-release on the same batch of a medicinal product;
  3. Dissolution of different medicinal products with the same active ingredients;
  4. Dissolution of different medicinal products with the same active ingredients with different Dissolution media

5. Premises control and hygiene control

Testing center Globaltest carries out sampling and/or testing using swabs from work surfaces and inventory; tests of drinking and purified water for the needs of pharmaceutical production, air sampling, development of methods for microbiological and chemical control of cleaning, selection of “worst possible case”, selection of critical points

6. Testing of packaging for medicinal products and nutritional supplements

7. EU GMP audits of partners and third parties, internal audits, and training

Testing center Globaltest offers conducting audits to establish compliance with GMP requirements of its partners and/or their suppliers, as well as conducting internal audits in companies with a small number of personnel. The objectives and program of each audit shall be determined jointly by the parties.

You can download a draft contract for testing / control of medicinal products, in accordance with the requirements of Ordinance No. 15 of the Ministry of Health of April 17, 2009, section X, from the “Forms” section

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