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Pharmaceutical Chemistry
Dexamethasone
Formula:
C22H29FO5
Dexamethasone is a highly potent synthetic glucocorticosteroid (GCS) exhibiting pronounced anti-inflammatory, anti-allergic, desensitizing, and immunosuppressive activities. The product is a white or almost white, odorless crystalline powder, practically insoluble in water. Due to its exceptional biological activity, stability, and reliable performance, Dexamethasone serves as an indispensable core active pharmaceutical ingredient (API) for manufacturing a diverse range of finished dosage forms in the modern pharmaceutical industry.
Applications
Injectable Dosage Forms: Utilized as the primary active ingredient in the formulation of sterile intravenous (IV) and intramuscular (IM) solutions used in emergency medicine and acute care therapies.
Ophthalmic & Otic Preparations: Extensively applied in the manufacturing of eye/ear drops, sterile suspensions, and ointments targeting severe inflammatory and allergic conditions of the sensory organs.
Solid Oral Dosages: Used in the production of tablets across various strengths, ensuring precise active ingredient distribution throughout the batch and consistent bioavailability.
Topical & Semi-Solid Forms: Incorporated into the formulation of specialized anti-inflammatory ointments, creams, and gels for dermatological applications.
Key Advantages
Superior Anti-Inflammatory Potency: Significantly outperforms hydrocortisone and prednisone in therapeutic activity, allowing for ultra-low dosing regimens to achieve the desired clinical effect.
Absence of Mineralocorticoid Effect: Does not promote sodium (Na+) or water retention in the body, drastically minimizing the risk of edema and associated blood pressure spikes when administered properly.
Ultra-High Purity Grade: This pharmaceutical-grade substance fully complies with stringent global pharmacopeia standards (USP, EP, BP), guaranteeing minimal impurity profiles.
Formulation Stability: Demonstrates excellent technological compatibility and blending stability with a wide variety of excipients commonly used in pharmaceutical manufacturing.
Storage & Transportation
- Store in dry, clean, light-protected warehouse facilities in tightly sealed original containers, out of reach of children.
- Recommended storage temperature: +15°C to +25°C. Avoid exposure to excessive heat and direct sunlight.
- Must be stored under strictly isolated and controlled conditions in compliance with international regulations for potent medicinal substances.
- Transportation is permitted via all types of covered transport, provided there is adequate protection from atmospheric precipitation and strict adherence to temperature guidelines. Shelf life ranges from 3 to 5 years from the date of manufacture (depending on specific manufacturer documentation).
Technical Specifications
Appearance
White or almost white, odorless crystalline powder
Assay (On Dried Basis)
97.0% – 102.0%
Specific Optical Rotation
+72° to +80°
Loss on Drying
Not more than 0.5%
Residual Solvents
Meets Pharmacopeia Requirements
Sulfated Ash
Not more than 0.1%
Supply info
- Double polyethylene bags enclosed within hermetic aluminum bags / canisters of 1 kg and 5 kg.
- Industrial-grade fiber drums of 10 kg and 25 kg tailored for large-scale commercial pharmaceutical manufacturing.
- Every shipment is accompanied by a comprehensive documentation package: Certificate of Analysis (CoA), MSDS, and Drug Master File (DMF) available upon request.