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Dexamethasone is a synthetic glucocorticoid corticosteroid widely used for its anti-inflammatory, immunosuppressive, and anti-allergic properties. It is effective in the management of inflammatory disorders, autoimmune diseases, allergic reactions, and certain endocrine disorders. Dexamethasone works by modulating the expression of anti-inflammatory proteins and suppressing pro-inflammatory mediators, providing rapid and potent relief.
Bluepill Express manufactures high-purity Dexamethasone API under WHO-GMP, ISO 9001:2015, and cGMP-certified facilities, ensuring consistent quality, stability, and compliance with IP, BP, USP, and EP standards. This API is suitable for tablet, injectable, ophthalmic, and topical formulations, catering to both domestic and international pharmaceutical markets.
Therapeutic Uses
- Anti-inflammatory Therapy: Rheumatoid arthritis, osteoarthritis, and other inflammatory conditions
- Allergic Disorders: Asthma, severe allergies, and dermatological reactions
- Autoimmune Diseases: Lupus, multiple sclerosis, and other autoimmune disorders
- Endocrine Disorders: Adrenal insufficiency and congenital adrenal hyperplasia
- Oncology Support: Reduces chemotherapy-induced nausea and inflammation
Mechanism of Action
Dexamethasone binds to glucocorticoid receptors (GR) and modulates gene expression:
- Suppresses pro-inflammatory cytokines
- Inhibits leukocyte infiltration at sites of inflammation
- Reduces edema, erythema, and pain
- Modulates immune response in autoimmune and allergic conditions
- Prolonged effects due to long half-life compared to other corticosteroids
Pharmacological Information
- Chemical Name: (11β,16α)-9-fluoro-11,17,21-trihydroxy-16-methylpregna-1,4-diene-3,20-dione
- Molecular Formula: C22H29FO5
- Molecular Weight: 392.47 g/mol
- CAS Number: 50-02-2
- Therapeutic Class: Glucocorticoid / Corticosteroid
- Pharmacological Class: Anti-inflammatory / Immunosuppressant
- ATC Code: H02AB02
Physical & Chemical Properties
| Property | Description |
|---|---|
| Appearance | White to off-white crystalline powder |
| Solubility | Slightly soluble in water; soluble in ethanol, chloroform, and acetone |
| Melting Point | 262°C – 264°C |
| pH (1% aqueous solution) | 6.0 – 7.0 |
| Storage | Store below 25°C in a dry, ventilated area, protected from light and moisture |
Technical Specifications
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR, UV, and HPLC positive |
| Assay (Purity) | ≥ 99.0% (HPLC) |
| Loss on Drying | ≤ 0.5% |
| Residue on Ignition | ≤ 0.1% |
| Heavy Metals | ≤ 10 ppm |
| Related Substances | ≤ 0.5% (individual impurity) |
| Bulk Density | 0.40 – 0.55 g/mL |
| Tapped Density | 0.55 – 0.70 g/mL |
Applications
Dexamethasone API is used in:
- Tablet, injectable, ophthalmic, and topical formulations
- Anti-inflammatory and immunosuppressive therapy
- Combination corticosteroid formulations
- Bulk API supply for domestic and international pharmaceutical markets
Documentation Provided
- Certificate of Analysis (COA)
- Material Safety Data Sheet (MSDS)
- Technical Data Sheet (TDS)
- Method of Analysis (MOA)
- Stability Data (ICH-compliant)
- Regulatory Dossier / DMF (on request)
Packaging & Export Details
- Available Packs: 1 kg | 5 kg | 10 kg | 25 kg HDPE drums with double poly liners
- Labeling: Product name, batch number, manufacturing/expiry dates, storage instructions
- Shelf Life: 36 months under recommended storage conditions
- Export Markets: Africa, Asia, Latin America, Europe, Middle East
