Dexamethasone API Supplier India | 2 Grades | Bulk Export

Aarise Pharmaceuticals supplies dexamethasone and dexamethasone sodium phosphate as bulk corticosteroid APIs from India.

Available Dexamethasone Grades

Choosing the Right Grade

Dexamethasone is a 9-fluoro, 16-alpha methyl corticosteroid with substantially higher glucocorticoid potency than hydrocortisone and negligible mineralocorticoid activity. The sodium phosphate salt is freely water-soluble and is the form used in injectable and ophthalmic solutions.

Quality Documentation — What to Request

The base compound is used in oral solid dose formulation where content uniformity at low dose is the controlling parameter, so particle size distribution should be requested alongside assay. For the sodium phosphate salt, water content and pH of a defined solution are the critical figures, since the salt is hygroscopic and solution pH affects stability.

Import, Licensing & Logistics

Dexamethasone APIs are not controlled substances. Standard pharmaceutical import licensing applies. Manufacturer GMP documentation is requested at customs in several markets.

Salt Form Selection

The choice between dexamethasone base and dexamethasone sodium phosphate is driven entirely by the dosage form. The base is practically insoluble and is used in oral solid dose and ophthalmic suspension. The sodium phosphate salt dissolves freely and is the form used in injectable and ophthalmic solutions, but it is hygroscopic and the solution pH affects degradation rate, so both water content and the pH of a defined solution should appear on the certificate.

Stability, Storage & Retest

Corticosteroids are photosensitive to varying degrees and several oxidise at the 11-hydroxyl or 21-hydroxyl positions on exposure to air and light. Store in the original sealed container protected from light. Soluble salt forms such as sodium phosphate and sodium succinate are hygroscopic and degrade on moisture uptake, so water content by Karl Fischer should be checked on receipt rather than relied on from the certificate if the consignment has been in transit through humid conditions.

Export Process & Lead Time

Corticosteroid APIs are not scheduled as controlled substances in most markets, which makes the export process considerably simpler than for anabolic compounds. A country of origin certificate and commercial invoice are usually sufficient. Several destinations, including a number of EU member states and Brazil, additionally require a manufacturer GMP certificate or a Certificate of Pharmaceutical Product at customs clearance, so confirm your national requirement before despatch.

Incoming Goods Inspection

Incoming checks should cover appearance, identification by IR against a reference standard, assay, and water content for the soluble salts. For material destined for topical or inhaled preparations, particle size distribution should be verified on receipt rather than accepted from the certificate, because micronised grades can agglomerate in transit and the finished product will not perform as expected.

Ordering Dexamethasone API

Packaging runs from 250 g sealed aluminium bags to 5 kg drums, with larger commercial quantities quoted on request. Specify the grade, quantity and destination at enquiry so the quotation reflects the correct MOQ and documentation set. Mixed consignments across grades in this range ship as a single shipment.