Product Overview
Methyl Prednisolone Sodium Succinate API is a very pure active pharmaceutical ingredient.
It has a high solubility in water. It is made using strict methods to ensure each batch’s quality and chemical stability.
It follows the strict rules for making and regulating medicines.
Therapeutic Applications
Methyl Prednisolone Sodium Succinate API is used to make corticosteroid drugs for injection.
The API is well-suited for parenteral and intramuscular products due to its stable chemistry.
It’s used in sterile formulation processes that require a water-soluble corticosteroid API with high purity.
Its consistent quality also makes it a great fit for large-scale drug manufacturing.
Specification Parameters
Methyl Prednisolone Sodium Succinate API meets high standards for purity and quality.
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Chemical Name (IUPAC): pregna-1,4-diene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-6-methyl-monosodium salt, (6α,11β)
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CAS Number: 2375-03-3
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Assay Method: HPLC
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Molecular Formula: C₂₆H₃₃NaO₈
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Molecular Weight: 496.53 g/mol
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Related Substances / Impurities: USP sets a limit. Free methylprednisolone must not exceed 6.6%.
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Residual Solvents: As per USP/ICH Q3C(R6) guidelines.
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Elemental Impurities: Compliant with ICH Q3D
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Loss on Drying / Water Content: NMT 2.0% at 105°C for 3 hours
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Identification Tests: USP-based chemical and physical identification.
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Appearance: A white or nearly white, odorless solid that absorbs moisture.
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Solubility: Soluble to a high degree in water and alcohol, insoluble in chloroform, and very slightly soluble in acetone.
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pH (reconstituted solution): 7.0 – 8.0
Packaging & Storage
Methyl Prednisolone Sodium Succinate API is packaged in fibre drums or HDPE drums.
Do not freeze the API. Store in a cool, dry place, protected from light and moisture.
Why Choose Us
Actiza Industry provides top-quality Methyl Prednisolone Sodium Succinate API.
We ensure it meets GMP standards and is consistent.
High Purity API
We make our Methyl Prednisolone Sodium Succinate API to high pharmacopeial standards and follow strict guidelines.
This approach helps us keep things consistent and stable.
Advanced Manufacturing
We’re using advanced automated machines, special control zones, and integrated packaging lines.
This setup helps us produce accurately, reduce contamination, and boost efficiency.
It fully complies with WHO-GMP and ISO standards.
Bulk Supply & Packaging
API is provided in secure bulk packaging. This includes double-layered plastic bags in fiber or HDPE drums.
To handle and deliver items safely, we use labels, keep them dry, and control the temperature.
Reliable Support
We give full support to its clients. This includes technical help, fast delivery, and customer service in every time zone.
We ensure transparency and quality at every stage of API production and supply.
