 |
| Product information |
Product name | Hydrocortisone |
Molecular Formula | C21H30O5 |
Molecular Weight | 362.46 |
CAS No. | 50-23-7 |
Quality Standard | EP/USP |
Appearance | White powder |
| COA of Hydrocortisone |
| Items | Specifications | Results |
|---|---|---|
| Appearance | A white or almost white, crystalline powder | White crystalline powder |
| Solubility | Practically insoluble in water, sparingly soluble in acetone and in alcohol, slightly in methylene chloride | Complies |
| Identification | ||
| A: IR-Spectrum | Meets the requirement | Complies |
| B: HPLC | Meets the requirement | Complies |
| Specific optical rotation | Between +162° and +168° | +165.4° |
| Loss on drying | Not more than 1.0% | 0.09% |
| Related substances | ||
| Impurity D RRT0.2 | Not more than 0.50% | 0.23% |
| Impurity H RRT0.3 | Not more than 0.15% | N.D |
| Impurity I RRT0.5 | Not more than 0.50% | 0.17% |
| Impurity M RRT0.7 | Not more than 0.10% | 0.09% |
| Impurity G RRT0.8 | Not more than 0.40% | 0.08% |
| Impurity E RRT0.86 | Not more than 0.50% | 0.09% |
| Impurity A RRT0.96 | Not more than 0.20% | 0.09% |
| Impurity B RRT1.1 | Not more than 0.20% | N. D |
| Impurity F RRT1.4 | Not more than 0.30% | 0.06% |
| Impurity C RRT1.5 | Not more than 0.50% | 0.08% |
| Impurity N RRT1.7 | Not more than 0.15% | N.D |
| Any unspecified impurity | Not more than 0.10% | Complies |
| Sum of impurities | Not more than 2.0% | 1.01% |
| Assay | Between 97.0% and 103.0% | 100.7% |
| Residual solvents (in-house) | ||
| Methanol | Not more than 500ppm | Not detect out |
| Ethanol | Not more than 2000ppm | Not detect out |
| Methylene chloride | Not more than 600ppm | Not detect out |
| Chloroform | Not more than 60ppm | Not detect out |
| Particle size (In-house ) | 90% not more than 15micron | Complies |
| Conclusion | The product conforms to Ph.Eur. 8.0 |
| Hydrocortisone – High-Purity Corticosteroid API for Pharmaceutical Applications |
Hydrocortisone (CAS 50-23-7) is a widely used corticosteroid hormone with strong anti-inflammatory and immunosuppressive properties. As an essential Hydrocortisone API, it is extensively utilized in topical creams, injections, tablets, and dermatological formulations. Available in high-quality Hydrocortisone powder, this active ingredient remains one of the most demanded products among global api manufacturers and pharmaceutical companies.
| Production & Manufacturing Process |
Our Hydrocortisone steroid is manufactured through advanced semi-synthetic and purification technologies to ensure high stability and pharmaceutical-grade consistency:
Raw Material Synthesis: Produced from steroidal intermediates through controlled hydroxylation and catalytic transformation processes.
Purification Technology: Multi-stage crystallization and precision filtration ensure high purity Hydrocortisone ≥99% API supplier standards.
Quality Optimization: Strict monitoring of residual solvents, impurities, and particle distribution improves formulation compatibility.
Scalable Manufacturing: As a professional Hydrocortisone bulk powder GMP supplier, we support industrial-scale production with stable supply capacity.
Applications & Pharmaceutical Value |
Anti-Inflammatory Therapy: Widely applied in creams, ointments, and injections for inflammation, allergy, and autoimmune-related conditions.
Dermatology & Skincare: Frequently used in topical formulations for eczema, dermatitis, and skin irritation management.
Hormonal Therapy: Supports adrenal insufficiency treatment and corticosteroid replacement therapy.
Pharmaceutical Formulation: Preferred by global drug manufacturers seeking competitive Hydrocortisone pharmaceutical raw material price and reliable API quality
Why Choose Us? |
Experienced api manufacturers with advanced steroid synthesis capability
Reliable Hydrocortisone USP/EP standard manufacturer production process
Competitive bulk supply and stable manufacturing output
Trusted partner for global pharmaceutical raw material sourcing
Hydrocortisone API continues to play a critical role in modern anti-inflammatory and endocrine therapies. With optimized manufacturing technology, high-purity Hydrocortisone powder, and scalable production capacity, we provide dependable solutions for pharmaceutical companies worldwide. As a professional Hydrocortisone COA DMF support supplier alternative, we focus on quality consistency, supply reliability, and long-term cooperation.
Contact us today for bulk pricing and production capacity information.
