Isofluorane

In the clinical iteration of inhalation anesthesia, isoflurane, as a representative variety of halogenated ether inhalation anesthetics, exerts dose-dependent sedative, analgesic and muscle relaxant effects by regulating the activities of γ-aminobutyric acid A receptors and glycine receptors in the central nervous system. It has a low blood-gas partition coefficient, smooth anesthesia induction and rapid awakening, and has a slight inhibitory effect on the circulatory system, rarely causing arrhythmia. At present, it is widely used in the induction and maintenance of general anesthesia in surgical operations, suitable for general surgical patients of all ages, and can also be used for anesthesia management in special scenarios such as cardiovascular diseases and craniocerebral operations. It is one of the basic drugs in clinical anesthesia.

The current global isoflurane market size is stable at around USD 1.2 billion, with a compound annual growth rate of approximately 2.3%. The demand growth mainly comes from the increase in surgical volume in emerging markets. In the domestic market, isoflurane has been included in the national centralized procurement catalog, the winning bid price has dropped by more than 60% compared with that before the centralized procurement, and the replacement rate of generic preparations has reached more than 90%. The supply end of API presents the characteristic of head concentration. Domestic leading manufacturers occupy more than 70% of the global production capacity by virtue of cost advantages. In addition to meeting the domestic demand for preparation production, they also export a large amount to markets such as Europe, America and Southeast Asia.

The original research enterprise of isoflurane is Abbott Laboratories, and the original research trade name is "Aerrane". Its core compound patent expired globally in 1975. The main dosage form approved by the original research is inhalation solution, with specifications including 100ml/bottle and 250ml/bottle, which has been included in the FDA Reference Listed Drug Catalog and China's *Catalog of Reference Preparations for Chemical Drugs*. According to the domestic API registration platform, more than 15 enterprises have obtained A-status registration numbers for isoflurane API, which can be used for associated preparation declaration; a number of generic isoflurane inhalation solutions have been approved for marketing in China, with sufficient supply. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for isoflurane API, most of which are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can fully support the impurity detection needs in the process of API R&D, quality research and routine production, helping enterprises efficiently complete compliance declaration and quality control.