General Information

Budesonide Impurities and Budesonide

Daicel Pharma synthesizes Budesonide impurities of exceptional quality, such as Budesonide 17-keto Impurity and Budesonide Related Compound G. These impurities are crucial to assess the purity, reliability, and safety of Budesonide, an active pharmaceutical ingredient. Besides, Daicel Pharma provides custom synthesis of Budesonide impurities to meet clients’ demands for worldwide delivery.

Budesonide [CAS: 51333-22-3] is a synthetic glucocorticoid. It has properties that can reduce inflammation and help regulate the immune system. Budesonide reduces inflammation and acts as a bronchodilator agent.

Budesonide: Use and Commercial Availability  

Budesonide is a corticosteroid medication used to manage and treat inflammatory diseases that affect the airways and gastrointestinal tract. It treats allergic rhinitis, upper respiratory allergies, asthma, chronic obstructive pulmonary disease (COPD), Crohn’s disease, and ulcerative colitis. The dosage and administration of Budesonide vary depending on the condition, the patient’s age, and prior therapy. It is available in various forms, including nasal sprays, inhalation suspensions, metered-dose inhalers, inhalation powders, and rectal foams. Budesonide is available under various brands such as Uceris, Tarpeyo, Rhinocort, Pulmicort, Ortikos, Entocort Ec, and more.

Budesonide Structure and Mechanism of Action 

The chemical name of Budesonide is (11β,16α)-16,17-[Butylidenebis(oxy)]-11,21-dihydroxypregna-1,4-diene-3,20-dione. Its chemical formula is C₂₅H₃₄O₆, and its molecular weight is approximately 430.5 g/mol.

Budesonide is a corticosteroid that possesses glucocorticoid activity. It binds to glucocorticoid receptors and causes anti-inflammatory effects.

Budesonide Impurities and Synthesis

During the manufacturing¹ of Budesonide, impurities may form and affect the safety and efficacy of the drug. They form during synthesis, degradation, and storage conditions. It is necessary to control and monitor impurity levels to ensure the quality and safety of the drug. Regulatory agencies, like the US FDA, have established guidelines and limits for these impurities.

Daicel Pharma offers a Certificate of Analysis (CoA) for Budesonide impurity standards, such as Budesonide 17-keto Impurity and Budesonide Related Compound G, generated from an analytical facility compliant with cGMP standards. The CoA includes a comprehensive characterization report comprising data from techniques like 1H NMR, 13C NMR, IR, MASS, and HPLC purity². Furthermore, on request, we can provide additional data like 13C-DEPT and CHN. Daicel Pharma can synthesize unknown Budesonide impurities or degradation products. A complete characterization report accompanies every delivery.