Division for Physical-Chemical Testing

Division for Physical-Chemical Testing, within the Department for Testing and Drug Quality Control

Information about the activity performed in Division for Physical-Chemical Testing

Department for testing and drug quality control with the authorization of the Drug Agency of R. North Macedonia, based on the "Law on Medicines and Medical Devices" ("Official Gazette of the Republic of Macedonia" no. 106/07, 88/10, 36/11, 53/11, 136/11, 11/12, 147/13 , 164/13, 27/14, 43/14, 88/15, 154/15, 228/15, 7/16, 53/16, 83/18, 113/18, 245/18" and "Official Gazette of RNM" No. 28/21) as well as by-laws, conducts independent testing, that is, analytical testing and quality control of medicines in order to confirm their compliance with previously approved quality specifications.

The following activities is being performed in the Divisions:

  1. regular quality control of every medicine placed on the market in the Republic of North Macedonia, at least once every five years;
  2. quality control of the first batch of the drug after obtaining an approval for placing it on the market;
  3. quality control at the request of the Macedonian Agency for medicines and medical devices (MALMED)
  4. for obtaining an approval for placing the medicine on the market or after issuing an approval at the request of the inspection authority;
  5. specific quality control of specific categories of drugs at the request of the Macedonian Agency for medicines and medical devices (MALMED)
  6. identification and determination of active components cannabidiol (CBD), (-)-D9- transtetrahydrocannabinol (D9-THC) and degradation product cannabinol in medicinal cannabis extracts and finished products that contain medicinal cannabis extract.

Drug control is examined according to approved quality specifications validated analytical procedures by the manufacturer or described in the current editions of the European Pharmacopoeia (Ph.Eur.), United States Pharmacopoeia (USP), British Pharmacopoeia (BP)

 

Measures and activities under the competence of the Division for Physical-Chemical Testing

The following accredited methods are performed :

  1. Clarity of liquids (2.2.1., Ph. Eur.)
  2. Color of liquids (2.2.2., Ph.Eur)
  3. Potentiometric determination of pH value (2.2.3., Ph. Eur.)
  4. Relative density (2.2.5., Ph. Eur.)
  5. Loss by drying (2.2.32., Ph. Eur.)
  6. Sulfated ash (2.4.14., Ph. Eur.)
  7. Total ash (2.4.16., Ph. Eur.)
  8. Disintegration of tablets and capsules (2.9.1., Test A, Ph. Eur.)
  9. Solubility test of solid dosage forms (paddle and basket apparatus) (2.9.3., Ph. Eur.)
  10. Mass uniformity in single-dose preparations (2.9.5., Ph. Eur.)
  11. Uniformity of content in single-dose preparations (2.9.6., Test A, Ph. Eur.)
  12. Determination of extractable volume in parenteral preparations (2.9.17., Ph. Eur.)
  13. Mass uniformity of delivered multi-dose containers (2.9.27., Ph. Eur.)
  14. Uniformity of dosage units (2.9.40., Ph. Eur.)
  15. Minimum charge (<755>, USP/NF)
  16. Injection Fill Volume (<697>, USP/NF)
  17. Filling Volume (<698>, USP/NF)
  18. Identification of active substances using the following techniques: UV/visible spectrophotometry; High Performance Liquid Chromatography (HPLC/DAD); chemical reactions; thin layer chromatography (UV detection and visual evaluation)
  19. Determination of content of active substances using the following techniques: UV/visible spectrophotometry; High Performance Liquid Chromatography (HPLC/DAD);
  20. Gravimetric techniques; Volumetric technician (Argentometric titrations; Iodometric titrations)
  21. Determination of related substances and degradation products using the following techniques: UV/visible spectrophotometry; High Performance Liquid Chromatography (HPLC/DAD)
  22. Test of related substances using thin layer chromatography technique (with UV detection, visual evaluation)
  23. Titrimetric determination of sodium chloride in sodium chloride infusion solution
  24. Titrimetric determination of glucose in glucose infusion solution
  25. HPLC method for identification and content determination of the active components cannabidiol (CBD), (-)-δ9- trans-tetrahydrocannabinol (δ9-THC) and the degradation product cannabinol (CBN)

Contact information

Contact person: Katerina Starkoska, grad. pharm, spec. in drug testing and control

Contact phone:  +389 2 312 50 44 ext. 18

Email: k.starkoska@iph.mk