Dexamethasone API – High Purity 99%

Dexamethasone (CAS No. 50-02-2) is a synthetic glucocorticoid compound with the molecular formula C₂₂H₂₉FO₅ and a relative molecular mass of approximately 392.47. Its appearance is a white to almost white crystalline powder. It is practically insoluble in water and slightly soluble in methanol and ethanol. Its specific optical rotation is +72° to +80° (dioxane).

Applications: As a glucocorticoid active pharmaceutical ingredient (API), dexamethasone is primarily used in the pharmaceutical industry for the development and manufacture of anti-inflammatory, antiallergic, and immunosuppressive formulations. It is also used as a chemical reference standard for pharmaceutical testing and quality standard research.

Dexamethasone exhibits potent anti-inflammatory activity. It reduces and prevents tissue responses to inflammation, thereby alleviating inflammatory symptoms. It suppresses the accumulation of inflammatory cells, including macrophages and leukocytes, at sites of inflammation. It also inhibits phagocytosis, lysosomal enzyme release, and the synthesis and release of inflammatory chemical mediators.

Immunosuppressive activity: Dexamethasone suppresses or prevents cell-mediated immune responses and delayed-type hypersensitivity reactions. It reduces the numbers of T lymphocytes, monocytes, and eosinophils, decreases the binding capacity of immunoglobulins to cell surface receptors, and inhibits interleukin synthesis and release. Consequently, it reduces the transformation of T lymphocytes into lymphoblasts and suppresses the development of primary immune responses. It also reduces the passage of immune complexes through basement membranes and decreases complement component and immunoglobulin concentrations.

1. Anti-inflammatory Activity: As a potent glucocorticoid API, dexamethasone inhibits the release of inflammatory mediators and reduces inflammatory cell infiltration, thereby alleviating inflammation-associated symptoms such as localized redness, swelling, and exudation.

2. Immunosuppressive Activity: Dexamethasone modulates the body's immune response by suppressing excessive immune activity, reducing immune cell activity, and attenuating associated immune-mediated reactions.

3. Antiallergic Activity: It inhibits signaling pathways associated with allergic reactions and reduces the release of allergy-related mediators, thereby alleviating a range of physiological manifestations associated with allergic responses.

1. Pharmaceutical Formulation Development: Used in the development of glucocorticoid drug formulations, formulation compatibility and excipient screening, and generic drug development projects, including laboratory-scale trials, pilot-scale production, process scale-up, and process validation.

2. Scientific Research and Analytical Testing: Supplied for pharmacological and immunological research at scientific research institutions and universities. It is also used to establish API quality standards, validate analytical methods, and conduct pharmaceutical formulation stability studies.

3. API Supply and Procurement: Supplied for cross-border pharmaceutical raw material trade and import/export operations. It can also support R&D projects involving impurity reference standard preparation and custom synthesis.

1. Product Quality

Dexamethasone API is manufactured to ensure consistent quality and batch-to-batch stability, with an HPLC assay of ≥99.0%. Related substances, moisture content, heavy metals, and other quality parameters are subject to strict control. The product features consistent powder characteristics and meets pharmacopoeial standards, making it suitable for pharmaceutical formulation development and export quality control requirements.

2. Analytical Testing Methods

The assay is determined by high-performance liquid chromatography (HPLC) using a C18 chromatographic column and a UV detector, with quantification performed by the external standard method.

Additional tests include identification, water content, residue on ignition, and heavy metal content. A Certificate of Analysis (COA) is issued for each batch, with authentic and traceable analytical data.

1. Product Packaging

Samples are sealed in vacuum-packed aluminum foil bags to protect the product from exposure to air and moisture.

For bulk orders, the product is packed in double-layer polyethylene (PE) inner bags and 25 kg fiber drums as outer packaging to provide protection against dust and moisture.

Customized packaging specifications are available upon request. All packaging is inspected individually before dispatch to ensure integrity and prevent leakage or damage resulting in powder loss.

2. Transportation Arrangements

Domestic orders are shipped through ambient-temperature logistics services. Care is taken during loading and unloading to avoid direct sunlight, rain exposure, and compression.

For export orders, pallets and stretch film are used to secure the cargo and enhance protection during long-distance ocean freight, reducing the risk of transit damage.

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