Thiotriazolin included into State Pharmacopoeia of Ukraine
In January 2017, Supplement 2.1 to the 2nd edition of State Pharmacopoeia of Ukraine (SPhU) came into effect. It includes monographs on the active ingredient of Thiotriazolin (tiazotic acid morpholinium salt) and the drug’s finished dosage forms. The monographs define the quality requirements for tiazotic acid morpholinium salt and describe a quality control methodology for the active pharmaceutical ingredient and finished pharmaceutical products (solution for injection and tablets).
The monographs are the first in SPhU's history to cover an original Ukrainian medicinal product. Their projects were approved by Prof. I. A. Mazur, who created the drug, and publicly debated on the website of the Ukrainian Scientific Pharmacopoeial Center for Quality of Medicines. "The Pharmacopoeia has a legal status and stipulates the requirements for medicinal products sold in the Ukrainian market, so this is our commitment to caring for our customers first of all,” Arterium Corporation’s Regulatory Affairs Director Serhii Sur said, “We worked for many years to get Thiotriazolin listed in the WHO's INN and ATC as well as the CAS, and incorporated into a variety of standards. The inclusion of the monographs into SPhU is a proof of the high quality of our medicinal products that will boost confidence of healthcare professionals and patients in them.”