PREDNISOLONE

Prednisolone API is a potent synthetic glucocorticoid with strong anti-inflammatory, antiallergic, and immunosuppressive properties. It is widely used in the treatment of a broad spectrum of conditions, including asthma, rheumatoid arthritis, skin diseases, inflammatory bowel disease, and autoimmune disorders.

At Bluepill Express, we manufacture and export high-purity Prednisolone API that complies with USP / BP / IP / EP standards, ensuring pharmaceutical-grade consistency and safety. The API is produced in WHO-GMP, ISO, and cGMP-certified facilities using advanced purification and crystallization technology for superior stability and bioavailability.

Prednisolone functions by mimicking the action of natural corticosteroids produced by the adrenal cortex, effectively reducing inflammation and suppressing immune overactivity. Its well-established efficacy and safety make it a cornerstone in corticosteroid therapy worldwide.

Bluepill Express ensures batch-to-batch uniformity, low impurity levels, and regulatory documentation support (COA, MSDS, DMF) for global pharmaceutical partners.

Therapeutic Applications:

• Treatment of inflammatory and allergic conditions (e.g., asthma, dermatitis, rhinitis)
• Management of autoimmune diseases such as lupus, rheumatoid arthritis, and multiple sclerosis
• Used in adrenal insufficiency replacement therapy
• Reduces inflammation in inflammatory bowel diseases like ulcerative colitis and Crohn’s disease
• Used as immunosuppressive therapy after organ transplantation

Mechanism of Action:

Prednisolone binds to glucocorticoid receptors and influences the expression of anti-inflammatory proteins while suppressing the transcription of pro-inflammatory cytokines. This dual action leads to reduced inflammation, swelling, and pain while modulating immune responses.

It inhibits leukocyte infiltration, decreases capillary permeability, and stabilizes lysosomal membranes, making it one of the most effective corticosteroids in clinical use.

Technical Specifications:

• Chemical Name: Prednisolone
• Molecular Formula: C₂₁H₂₈O₅
• Molecular Weight: 360.45 g/mol
• CAS Number: 50-24-8
• Description: White to off-white crystalline powder
• Melting Point: 234°C – 238°C
• Solubility: Practically insoluble in water; freely soluble in alcohol, acetone, and chloroform
• Assay (on dried basis): NLT 98.0%
• Specific Optical Rotation: +112° to +122°
• Storage: Store in a cool, dry place away from light and moisture

Pharmacological Classification:

• Therapeutic Class: Corticosteroid / Glucocorticoid
• Pharmacopoeial Standards: USP / BP / IP / EP
• Dosage Form Applications:
  • Tablets (1 mg, 5 mg, 10 mg, 20 mg)
  • Oral Suspension
  • Injection
  • Eye and Ear Drops
  • Topical Creams & Ointments

Quality & Manufacturing – Bluepill Express Standards:

• Manufactured in WHO-GMP, ISO 9001:2015, and cGMP-certified facilities
• Meets USP / BP / IP / EP standards for purity and potency
• Controlled crystal form for improved dissolution and formulation stability
• Comprehensive quality control via HPLC and UV spectrometry
• Supplied with full regulatory documentation: COA, MSDS, DMF (on request)
• Export-ready with customizable packaging and labeling

Advantages of Bluepill Express Prednisolone API:

• High assay value with minimal residual solvents
• Global regulatory compliance for multi-region export
• Consistent batch quality and stability
• Support for formulation partners with technical and analytical data
• Available in bulk quantities with prompt worldwide delivery

Packaging & Export Details:

• Packaging Sizes: 1 kg, 5 kg, 10 kg, 25 kg HDPE containers with LDPE liners
• Labeling: Compliant with international regulatory guidelines
• Shelf Life: 36 months under recommended storage conditions
• Export Markets: Africa, Asia-Pacific, Middle East, Europe, Latin America
• Documents Provided:
  • Certificate of Analysis (COA)
  • Material Safety Data Sheet (MSDS)
  • Drug Master File (DMF) – available on request
  • BSE/TSE-Free & Non-GMO declarations