General Information

Mometasone Furoate Impurities and Mometasone Furoate

For evaluating the purity and safety of Mometasone Furoate, an active pharmaceutical ingredient, Daicel Pharma offers a customized synthesis of Mometasone Furoate impurity standards. These impurity standards include crucial compounds such as Mometasone Furoate Anhydrous 8-DM (Impurity L), Mometasone Furoate Anhydrous DMC (Impurity Q), Mometasone Furoate Anhydrous DMCF (Impurity D) and more. Additionally, Daicel Pharma provides worldwide delivery options for Mometasone Furoate impurity standards.

Mometasone Furoate [CAS: 83919-23-7] is a synthetic topical glucocorticoid receptor (GR) agonist. It has vasoconstrictive, anti-inflammatory, and antipruritic properties. It treats asthma, allergic rhinitis, and various skin disorders.

Mometasone Furoate: Use and Commercial Availability  

Mometasone Furoate, marketed under brand names like Asmanex HFA, Asmanex Twisthaler, Elocon, Nasonex, Nasonex 24HR allergy, and Sinuva, offers multiple treatment options. It is available as an inhalant for preventing asthma in patients aged four years and older. As a topical ointment, it treats dermatitis and pruritus in patients aged two years and above. The nasal spray form is offered both over-the-counter and by prescription. The OTC nasal spray is for upper respiratory allergic symptoms in patients aged two years and above. The prescription nasal spray is for chronic rhinosinusitis with nasal polyps in patients aged 18 years and above. It prevents seasonal allergic rhinitis in patients aged 12 years and older.

Mometasone Furoate Structure and Mechanism of Action

The chemical name of Mometasone Furoate is (11β,16α)-9,21-Dichloro-17-[(2-furanylcarbonyl)oxy]-11-hydroxy-16-methylpregna-1,4-diene-3,20-dione. Its chemical formula is C₂₇H₃₀Cl₂O₆, and its molecular weight is approximately 521.4 g/mol.

The precise mechanism of action of Mometasone Furoate is unclear.

Mometasone Furoate Impurities and Synthesis

Like any chemical compound, Mometasone Furoate¹ may contain impurities that can impact its quality and safety. Common impurities in Mometasone Furoate formulations can include related substances, residual solvents, and degradation products. Regulatory guidelines provide limits for these impurities to ensure product quality and safety. Manufacturers employ strict quality control measures and analytical techniques to monitor and control impurity levels in Mometasone Furoate.

Daicel Pharma strictly adheres to cGMP standards and operates an analytical facility for the preparation of Mometasone Furoate impurity standards, which include Mometasone Furoate Anhydrous 8-DM (Impurity L), Mometasone Furoate Anhydrous DMC (Impurity Q), and Mometasone Furoate Anhydrous DMCF (Impurity D). Mometasone Furoate impurity standards have a detailed Certificate of Analysis (CoA) that provides a comprehensive characterization report. This report includes data obtained through techniques, 1H NMR, 13C NMR, IR, MASS, and HPLC purity analysis². Upon request, we give additional data like 13C-DEPT. Moreover, we can synthesize unknown Mometasone Furoate impurity standards and degradation products. Each delivery has a comprehensive characterization report, ensuring quality and transparency.