Product Overview
Methyl Prednisolone Base and Acetate API are synthetic steroid ingredients.
They come in several chemical forms. The Base and Acetate variants have unique structures and properties.
This supports different formulation needs. These APIs are made with controlled, cGMP-compliant processes. They are available in trusted quality grades.
Therapeutic Applications
Methyl Prednisolone Base and Acetate API are important for making corticosteroid products.
The Base form is often used to make solid and liquid formulations.
The acetate form is more suitable for making suspensions and injectables.
These APIs serve a range of formulation needs in regulated pharmaceutical manufacturing.
Specification Parameters
These parameters highlight the key aspects of Methyl Prednisolone Base & Acetate API.
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Chemical Name (IUPAC): Methyl Prednisolone Base: 11β,17α-dihydroxy-6α-methylpregna-1,4-diene-3,20-dione, Methyl Prednisolone Acetate: 21-acetoxy-11β,17-dihydroxy-6α-methylpregna-1,4-diene-3,20-dione
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CAS Number: Base: 83-43-2 Acetate: 53-36-1
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Molecular Formula: Base: C₂₂H₃₀O₅ Acetate: C₂₄H₃₂O₆
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Molecular Weight: Base: ~374.48 g/mol Acetate: 416.51 g/mol
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Appearance: White or almost-white powder/solid
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Identification Tests: Comparison of Retention Times HPLC.
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Residual Solvents: Comply with ICH Q3C requirements.
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Related Substances / Impurities: Kept within pharmacopeial and ICH limits.
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Elemental Impurities: Meet ICH Q3D guidelines.
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Loss on Drying / Water Content: Within set pharmacopeial limits.
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Particle Size Distribution: Kept in check, particularly for the acetate grade.
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Microbial limits: not required for non-sterile API or as specified.
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Assay Method: HPLC (as per USP/BP/EP)
Packaging & Storage
Methyl Prednisolone Base & Acetate API is packed in clean, protective materials to maintain quality.
The API is placed inside HDPE or fiber drums for safety.
These drums are stored in a cool, dry place to prevent degradation from light or moisture.
Why Choose Us
Actiza Industry is a reliable partner for Methyl Prednisolone Base and Acetate API needs.
Our manufacturing systems are robust, and we value quality.
Integrated Manufacturing
Our complete API facilities give us better control over raw materials, processes, and quality.
This framework keeps API batches aligned with global standards and ensures they meet customer needs.
Quality Standards
Our manufacturing is based on the WHO-GMP and ISO guidelines.
We use automated systems and maintain clean zones, which are subject to strict quality checks.
This helps us ensure that every API batch is of the highest purity, safety, and quality.
Strong Infrastructure
Facilities nowadays have advanced machinery and efficient HVAC systems.
These controlled environments boost the efficiency of API production.
R&D teams are dedicated to enhancing processes. They aim for a stable, scalable, and cost-effective API supply.
Customer Focus
You can choose your order size and customize your packaging.
To ensure everything runs smoothly, we keep communication open.
We assist with regulations and respond to your queries.
