Sodium Lactate

Electrolyte disorder is a problem requiring key intervention during clinical fluid supplementation and metabolic acidosis correction. As one of the core varieties of alkaline electrolyte supplements, sodium lactate is converted into bicarbonate through oxidative metabolism in the liver in vivo, exerting the effects of regulating body fluid acid-base balance and supplementing sodium ions. It is mainly used clinically to correct metabolic acidosis, and can also be used as an important component of peritoneal dialysis solutions and intravenous rehydration solutions. Meanwhile, it is a pH regulator for some topical preparations, and the applicable population covers patients with renal insufficiency accompanied by acidosis, people receiving dehydration rehydration, and demanders for related preparation production.

The global market size of sodium lactate active pharmaceutical ingredient (API) was approximately USD 230 million in 2023, and the compound annual growth rate is expected to remain at around 4.8% by 2029. The core growth drivers come from the market expansion of large volume parenterals and dialysis preparations, as well as the increasing demand for additives in the daily chemical and food fields. In the current global supply pattern, Chinese enterprises account for about 62% of the production capacity share, and leading enterprises are concentrated in Shandong, Jiangsu and other regions. The continuous implementation of domestic centralized procurement-related infusion varieties has further driven the demand for compliant sodium lactate APIs. The overall market competition is sufficient, but there is still a supply gap in high-level compliant production capacity.

The original research enterprise of sodium lactate is Otsuka Pharmaceutical Co., Ltd. of Japan, with the original research trade name Sodium Lactate Injection. The core compound patent has entered the public domain, and there is no valid core patent. The marketed original research dosage forms are mainly injections, with conventional specifications including 20ml:2.24g and 50ml:5.60g. Its injection product has been included in the FDA Reference Listed Drug Catalog, and the domestic *Catalog of Reference Preparations for Chemical Drugs* also includes the injection dosage form of this variety. Up to now, there are 19 registration records of sodium lactate APIs on the domestic CDE API Registration Platform, of which 12 have been publicized in A status. The number of domestically approved varieties such as sodium lactate injection and compound rehydration preparations containing sodium lactate has exceeded 80, and the supply system is mature. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of sodium lactate impurity reference standards, covering all categories such as synthetic process impurities and degradation impurities. Most products are in stock. Spot orders placed before 16:00 can be shipped on the same day. All products meet the requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the compliance needs of different scenarios such as API quality research and preparation consistency evaluation.