Hydrocortisone Intermediate | GMP-Certified API Synthesis | HPLC/GC-MS Validated
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Product Overview
Hydrocortisone Intermediate is a high-purity pharmaceutical reference standard essential for synthesizing corticosteroids, anti-inflammatory APIs, and topical formulations. It ensures compliance in drug development for adrenal insufficiency, autoimmune disorders, and dermatological therapies13.
Key Advantages
✔ >99.5% Purity: Validated by HPLC/GC-MS with full chromatographic reports13.
✔ GMP/ICH Compliance: Manufactured under ISO 9001 and pharmacopeial guidelines (USP/EP)35.
✔ Multi-Format Stability: 24-month shelf life (-20°C) with batch-specific CoA34.
Applications
◈ Corticosteroid API synthesis (e.g., hydrocortisone acetate, hemisuccinate)56.
◈ QC testing for topical creams, injectables, and ophthalmic solutions36.
◈ Method validation for EP/USP monographs and impurity profiling35.
Quality Certifications
◼ USP/EP/ICH compliant: Comprehensive analytical data (IR, NMR, MS)35.
◼ Stability tested: Accelerated degradation studies per ICH Q1A(R2)34.
Market Trends
The global corticosteroids market is projected to reach $6.8B by 2030, driven by rising demand for autoimmune disease therapies35. Hydrocortisone derivatives dominate 65% of dermatology drug formulations, including eczema and psoriasis treatments46.
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Optimized Keywords:
- Anti-Inflammatory API Intermediate
- Steroid Hormone Synthesis
- Adrenal Insufficiency Treatment
- Topical Cream Formulations
- USP/EP Compliance Standards
Additional High-Value Keywords:
Pharmaceutical Excipient Grade Hydrocortisone
Injectable Steroid Preparations
Autoimmune Disease Therapeutics
Dermatology Drug Development
Corticosteroid Impurity Profiling
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