Direct factory supply adhering to global cGMP standards with comprehensive technical file support.
Mometasone Furoate (CAS Registry Number: 83919-23-7) represents a medium-potency, synthetic 17-heterocyclic glucocorticoid corticosteroid engineered specifically for targeted anti-inflammatory, anti-pruritic, and anti-allergic applications. Chemically designated as (11β,16α)-9,21-dichloro-11-hydroxy-16-methyl-3,20-dioxopregna-1,4-dien-17-yl furan-2-carboxylate, its unique molecular framework combines halogenated substitution (chlorine atoms at positions 9 and 21) with a lipophilic furoate ester moiety at the 17-alpha position.
Key Technical Parameter: The introduction of the 17-furoate ester significantly increases glucocorticoid receptor affinity while ensuring minimal systemic absorption (< 1%), making Mometasone Furoate the gold standard active pharmaceutical ingredient (API) for topical dermatological preparations, nasal sprays for allergic rhinitis, and dry powder inhalers (DPI) for maintenance asthma therapy.
As a leading China Mometasone Furoate Factory & Exporter, Gentolex Chemical Group operates state-of-the-art cGMP-compliant manufacturing infrastructure designed to supply high-purity, micronized API to global pharmaceutical formulators across North America, Europe, Latin America, Asia-Pacific, and the Middle East.
Analyzing the structural cost efficiency, backward integration, and scalable synthesis capacities of Chinese chemical manufacturing.
China's rich steroid precursor ecosystem (diosgenin and hecogenin derivative pathways) ensures complete backward integration. Factories maintain uninterrupted access to key steroidal backbones, shielding global buyers from market volatility.
Inhalation and nasal drug delivery demand stringent physical specifications. Chinese production facilities deploy fluid-energy jet milling under cryogenic conditions to guarantee tailored particle size distribution (PSD) tailored to customer formulation needs.
Gentolex's facilities comply strictly with US FDA, EDQM, WHO-GMP, and NMPA cGMP requirements. Extensive stability testing (ICH Q1A-Q1E) and comprehensive Drug Master Files (DMF) facilitate rapid regulatory registration.
Below is the standard industrial purity matrix maintained by Gentolex for commercial API batches of Mometasone Furoate. Custom physical parameters (polymorphic form control, specialized mesh sizing) can be engineered upon commercial request.
| Test Parameter | Standard Acceptance Criteria | Analytical Methodology |
|---|---|---|
| Chemical Name | 9,21-dichloro-11β,17-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione 17-(2-furoate) | IUPAC Standard |
| CAS Registry Number | 83919-23-7 | CAS Index |
| Appearance | White to off-white crystalline powder | Visual / Colorimetry |
| Assay (Purity) | 98.0% – 102.0% (Dried Basis) | HPLC (USP/Ph. Eur.) |
| Individual Impurity | ≤ 0.10% | High-Performance Liquid Chromatography |
| Total Impurities | ≤ 0.50% | HPLC Chromatographic Profile |
| Loss on Drying (LOD) | ≤ 0.50% | Thermogravimetric Analysis / 105°C |
| Residue on Ignition | ≤ 0.10% | Sulfated Ash Assay |
| Micronized PSD (D90) | Customizable: D90 < 5.0 μm (Inhalation) / D90 < 10 μm (Nasal/Topical) | Laser Diffraction (Malvern Mastersizer) |
| Residual Solvents | Complies with ICH Q3C Guidelines (Methanol, Acetone, DCM within limits) | GC-HS (Gas Chromatography-Headspace) |
From topical dermatological ointments to pulmonary aerosol suspension technology.
Formulated as a 0.05% w/w aqueous suspension. Due to its extremely low systemic bioavailability, Mometasone Furoate provides powerful localized anti-inflammatory relief for seasonal and perennial allergic rhinitis without systemic corticosteroid side-effects.
Utilized at 0.1% strength for inflammatory dermatoses such as psoriasis, atopic dermatitis, and severe eczema. The furoate ester enhances skin penetration into the lipophilic stratum corneum while limiting dermal atrophy.
Engineered with ultra-fine particle sizes (1–3 μm) for deep pulmonary deposition. Prescribed for long-term maintenance treatment of asthma and chronic obstructive pulmonary disease (COPD), frequently combined with long-acting beta-agonists (LABAs).
Gentolex’s goal is to create opportunities connecting the world with better services and guaranteed products. Up to date, Gentolex Group has been serving customers from more than 10 countries, specially, representatives are established in Mexico and South Africa. Our main services focus on supplying peptides APIs and Custom Peptides, FDF license out, Technical Support & Consultation, Product Line and Lab Setup, Sourcing & Supply Chain Solutions.
An overall factory construction area of 250,000 square meters under international standard allows Gentolex to offer flexible, scalable and cost-effective solutions. Gentolex offers an extensive range of APIs and intermediates for development study and commercial application with cGMP standard from long-term collaborations. Documents and Certificates are supported to customers worldwide. For those clients who prefer to avoid the complexity of dealing with multiple points of contact, we provide extra customized procurement services with the most superior and comprehensive supply chain sources.
Gentolex maintains robust corporate partnerships across international pharmaceutical markets:
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