Propofol

General anesthesia is the core support for the smooth implementation of surgical operations. As a core variety in the field of short-acting intravenous anesthetics, propofol belongs to γ-aminobutyric acid A receptor agonists. By enhancing the conduction effect of inhibitory neurotransmitters, it can rapidly induce anesthesia within 30-60 seconds, with rapid and complete recovery and a low incidence of postoperative nausea and vomiting. It has become one of the preferred drugs for outpatient painless diagnosis and treatment, induction and maintenance of general anesthesia, and sedation of patients in intensive care units, covering adults, children of all ages and elderly surgical populations, and is an indispensable basic variety in the clinical anesthetic drug system.

The global propofol market size is steadily over 1.8 billion US dollars, with the Chinese market accounting for nearly 35%, and the compound annual growth rate in the past three years has remained at 4.2%. The growth momentum mainly comes from the expansion of demand for outpatient minimally invasive diagnosis and treatment such as painless gastroenteroscopy and medical aesthetic surgery. At present, the domestic market competition pattern is clear. The original research product occupies about 40% of the high-end hospital market, and domestic generic drugs have achieved full coverage of the primary market relying on cost advantages. Among them, the 10ml/100mg specification has been included in multiple rounds of national centralized procurement, and the maximum price reduction of the selected products compared with the original research is more than 80%, which has significantly reduced the medication burden of patients.

The original research enterprise of propofol is AstraZeneca, and the original trade name is "Diprivan". Its core compound patent expired globally in 2008, and the preparation patent in China also expired in 2011. At present, the main dosage form of the original research product marketed in China is injectable emulsion, including three common specifications of 10ml:0.1g, 20ml:0.2g and 50ml:0.5g, which has been included in the *Catalogue of Reference Preparations for Chemical Drugs* issued by the NMPA and is the reference standard for the consistency evaluation of domestic generic drugs. As of now, China's NMPA has approved the marketing registration of propofol APIs from more than 30 enterprises, among which more than 15 API enterprises have passed the A-status registration, and more than 60 domestic varieties of corresponding injections have been approved, which can fully meet the clinical supply demand. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full set of propofol impurity reference standards, covering synthetic impurities, degradation impurities and enantiomeric impurities. Most of them are in stock. Orders for in-stock products placed before 16:00 can be shipped on the same day. All reference standards meet the requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can fully meet various needs of API quality research, consistency evaluation and daily release testing.