Pethidine

Opioid analgesics are the core category of drugs used in the management of moderate to severe pain. Pethidine, as a synthetic opioid receptor agonist, exerts analgesic and sedative effects by activating the μ-opioid receptor in the central nervous system. Its analgesic potency is approximately 1/10 that of morphine, with a duration of action of 2 to 4 hours. Compared with morphine, it is less likely to cause constipation and urinary retention. It is mainly used clinically for moderate to severe pain caused by trauma, post-surgery, advanced cancer and other conditions. It can also be used as pre-anesthetic medication and a component of artificial冬眠合剂. It is indicated for adult pain patients without severe respiratory depression risk and no history of allergy to opioids. As it can cross the placental barrier, the progress of labor must be strictly evaluated when it is used for labor analgesia.

The current global market size of opioid analgesic APIs is approximately USD 2.8 billion, of which synthetic opioids account for 42%, with a compound annual growth rate of approximately 3.7%. Affected by special control policies, the pethidine market is highly concentrated. The global compliant production capacity is mainly concentrated in mainland China, India and the European Union. Restricted by the designated production system for narcotic drugs in the domestic market, only 3 enterprises have the production qualification for APIs. The annual sales of the preparation market are stable at around RMB 120 million. Affected by the promotion of new-generation opioids, the market size has decreased by approximately 2.1% annually in the past 3 years.

The original developer of pethidine is Merck KGaA, Germany, with the original brand name Demerol. The core compound patent expired globally in 1970. At present, the main dosage forms approved in China include pethidine hydrochloride injection (1ml:50mg, 2ml:100mg) and pethidine hydrochloride tablets (25mg, 50mg), both of which have been included in the National List of Reference Preparations for Chemical Drugs. According to the domestic API registration platform, there are currently 3 A-status registration numbers for pethidine hydrochloride APIs, all held by domestic designated production enterprises, and the corresponding preparation varieties have all passed the quality and efficacy consistency evaluation of generic drugs. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for pethidine API, covering synthetic process intermediates, degradation impurities and specific related substances, which can meet customers' needs throughout the whole process from process development to quality research and registration submission. Most products are available in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and complete technical documents such as structure confirmation and content calibration can be provided.