Supplement 6th to the 2nd Edition of the State Pharmacopoeia of Ukraine (SPhU 2.6) was approved by order of the Ministry of Health of Ukraine on February 17th, 2023.
Along with the texts introduced or revised in accordance with the corresponding changes in the Ph. Eur., the following national texts were introduced or revised.
A. New texts and monographs:
- Identification by retention time or volume (national part to 2.2.46. Chromatographic separation techniques);
- Integral test for verification of the analytical system and personnel qualification for the spectrophotometry method (new section to the national text 5.3.N.1. Statistical analysis of chemical test results);
- Statistical criterion power (new section to the national text 5.3.N.1. Statistical analysis of chemical test results);
- Prediction of total measurement uncertainty for the assay procedure (new section to the national text 5.3.N.2. Validation of analytical procedures and tests, with an example).
- Cosmetic products;
- Mesenchymal stem cells for human use;
- Mesenchymal stem cells for use in veterinary medicine;
- Aqueous extracts manufactured in pharmacies.
B. Revised texts:
- Metrological aspects of the certification and use of reference standards of the State Pharmacopoeia of Ukraine (national part to 5.12. Reference standards)