HYDROCORTISONE MICRONISED

Hydrocortisone Micronised API is a glucocorticoid corticosteroid widely used for its anti-inflammatory, immunosuppressive, and antiallergic properties. The micronised form enhances bioavailability and ensures rapid and consistent absorption, making it ideal for oral, topical, and injectable formulations.

At Bluepill Express, we are a WHO-GMP, ISO 9001:2015, and cGMP-certified manufacturer and exporter of Hydrocortisone Micronised Active Pharmaceutical Ingredient (API). Our API complies with USP, BP, IP, and EP standards, guaranteeing high purity, uniform particle size, and low impurity content for pharmaceutical formulation applications.

Hydrocortisone Micronised is commonly used in oral tablets, topical creams, ointments, and injectable solutions, providing effective relief from inflammatory, allergic, and autoimmune conditions.

Therapeutic Applications:

• Anti-inflammatory therapy for arthritis, bursitis, and dermatitis
• Allergic reactions such as asthma, rhinitis, and anaphylaxis
• Autoimmune diseases including lupus, multiple sclerosis, and rheumatoid arthritis
• Adrenal insufficiency replacement therapy
• Combination therapy with other immunosuppressants
• Topical and systemic corticosteroid formulations

Mechanism of Action:

Hydrocortisone exerts its effects by binding to glucocorticoid receptors, modulating the transcription of anti-inflammatory proteins and suppressing pro-inflammatory cytokines. This leads to reduced inflammation, edema, and immune response, restoring tissue homeostasis and alleviating symptoms of chronic or acute inflammatory conditions.

Technical Specifications:

• Chemical Name: 11β,17α,21-Trihydroxypregn-4-ene-3,20-dione
• Molecular Formula: C₂₁H₃₀O₅
• Molecular Weight: 362.46 g/mol
• CAS Number: 50-23-7
• Description: White to off-white micronised crystalline powder
• Assay (on dried basis): NLT 98.0% and NMT 102.0%
• Melting Point: 215°C – 220°C
• Solubility: Slightly soluble in water, freely soluble in ethanol, methanol, and acetone
• Storage Conditions: Store in a cool, dry place below 30°C, protected from light and moisture

Pharmacological Classification:

• Therapeutic Class: Corticosteroid / Glucocorticoid
• Pharmacopoeial Standards: IP / BP / USP / EP
• Dosage Form Applications:
  • Oral tablets and capsules
  • Topical creams, ointments, and lotions
  • Injectable solutions for systemic use
  • Combination formulations with other anti-inflammatory drugs

Quality & Manufacturing – Bluepill Express Standards:

• Produced in WHO-GMP, ISO, and cGMP-certified facilities
• Micronised for optimal absorption and bioavailability
• Verified by HPLC, IR, and UV spectroscopy
• Batch-to-batch consistency ensuring uniform particle size and purity
• Compliance with USP/BP/IP pharmacopeial standards
• COA, MSDS, and DMF available for regulatory and export requirements

Advantages of Bluepill Express Hydrocortisone Micronised API:

• High purity and micronised particle size for enhanced formulation performance
• Regulatory-ready API suitable for export to global markets
• Reliable bulk supply with flexible packaging
• Enhanced bioavailability and consistent therapeutic effect
• Extended shelf-life under recommended storage conditions

Packaging & Export Details:

• Packaging Sizes: 1 kg / 5 kg / 25 kg HDPE drums with LDPE inner liner
• Shelf Life: 3 years under recommended storage
• Labeling: Compliant with international pharmacopeial and export norms
• Export Markets: Europe, Africa, Asia-Pacific, Middle East, Latin America
• Documentation Provided:
  • Certificate of Analysis (COA)
  • Material Safety Data Sheet (MSDS)
  • Drug Master File (DMF – on request)
  • Stability and regulatory compliance certificates