Diacerein API

CAS No.	13739-02-1
Therapeutic Category	Anti-inflammatory
Technology	Synthetic
Dosage Form	Oral Solids
Innovator Brand	Rheumacal (France）
Registration Status	PV
Polymorph	/
GMP	FDA(USA)/NMPA(China)/MFDS(Korea) approved
EHS	ISO 14001 & 45001 certified

Product Description

Grade: Active Pharmaceutical Ingredient(API)
Chemical Name:4,5-diacetyloxy-9,10-dioxoanthracene-2-carboxylic acid
Molecular Formula:C₁₉H₁₂O₈
Molecular Weight:368.29
Specification: Enterprise Standard established according to ChP/USP/EP
Appearance: Powder
Total impurities: not more than 0.5%
Purity: not less than 99%
Residual Solvents: fully comply with ICH Q3C
Mutagenic impurities: fully comply with ICH M8
Nitrosamine assessment: available
Particle size: regular grade or milling/sieving according to customer’s requirement.
Storage: Room temperature
Production capacity: Commercial
Standard Package: 1kg/bag, 5kg/bag, or according to the customer’s requirement

Diacerein is an orally available anthraquinone compound, and its mechanism of action is related to the inhibition of interleukin-1 (IL-1). Studies have shown that Diacerein can inhibit the production of IL-1 converting enzyme, thereby interfering with the activation process of IL-1β and regulating downstream inflammatory pathways through this mechanism. Currently, Diacerein has been used in mechanistic studies of inflammation and cartilage degeneration associated with osteoarthritis. Additionally, this compound has demonstrated properties of relieving airway spasm and reducing local airway inflammation in animal models, making it applicable for experimental exploration of the pathological mechanisms of bronchial asthma.

Qingmu’s Diacerein API has been filed in China(DMF filed and listed on CDE’s website), DMF in CTD format is available and can be supported for registration worldwide.
Qingmu’s factory is established according to ICH/USFDA/EU/JAPAN/China regulations and current GMP, totally complies with environmental law in China, no risk to remove factory. A new API factory is under design and is predicted to be put into use in 2025.
As a China Diacerein manufacturer, Qingmu’s team has rich experience in patent challenges on crystalline form & synthesis processes and also synthetic route development and scale-up & quality research.
Qingmu’s lab is equipped with HPLC, GC, ICP-MS, GC-MS, CAD, microbalance, Malvern particle analyzer, etc. Qingmu passed the site inspection from NMPA(China), FDA(USA) and MFDS(Korea) and also customer audits from Europe, USA and Japan, etc.
Qingmu successfully exported products to more than 40 countries including Japan, USA, Germany, Spain, the Netherlands, Russia, South Korea, and Brazil. So please feel free to choose us.