Dexamethasone Powder

Dexamethasone Powder (99% Purity) | Pharmaceutical-Grade API Supplier & Manufacturer

Drug-grade Dexamethasone Powder, with the CAS number 50-02-2 and a white crystal appearance, is made and sold by GMP-certified Shaanxi Hongda Phytochemistry Co., Ltd. This is a synthetic glucocorticoid API that can reduce inflammation 25–30 times better than hydrocortisone. It can be used in tablet, suspension, topical, and animal forms. Every year, we can make and ship up to 3,000 tons of goods. It takes us 3–7 business days to do this. Ones that let you send goods to Europe, North America, and Asia are KOSHER, HALAL, BRC, ISO9001, and ISO22000.

Product Introduction

Dexamethasone Powder is a very strong glucocorticoid-class synthetic corticosteroid API. Its chemical formula is C₂₂H₂FO₅ and its name is 9-fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione. 392.46 g/mol is how heavy it is.

The material is a crystalline powder that is white or almost white and doesn't mix with water at all. Some of it dissolves in acetone and ethanol (96%), but none of it dissolves in methylene chloride. The drug breaks down between 262°C and 264°C, and its half-life in cells is between 36 and 54 hours. This makes it a long-acting steroid.

One of its effects is not very strong as a mineralocorticoid, so it does not cause sodium accumulation like some other corticosteroids do. Due to this, it is a better choice for lower-dose formulations that need to be precise in their therapy.

Product Specification

Third-Party Test Report

Before being sent out, every batch is tested in our own SGS-certified lab. We also work with authorised third-party agencies, like SGS and Eurofins, to make sure that important quality standards are met.

Third-party testing checks for heavy metals, microbiological safety, nutritional labelling, pesticide residues, and leftover solvents (Class 1, 2, and 3 per ICH Q3C). Specific optical rotation testing proves chirality between +70° and +82°, proving that the enantiomer in question is the right one for biological activity.

You can get all test reports if you ask for them. Before you place an order, you can get paperwork from our team.

Certificate of Analysis (COA)

Each shipment comes with a full COA covering all critical inspection items required by QA teams and procurement managers.

COA documents are traceable per batch. Contact Us to request a sample COA before ordering.

Dexamethasone Powder Advantages

High Potency at Low Dosage

It works 25–30 times better than hydrocortisone at reducing inflammation. This lets manufacturers use a lot fewer milligrammes per dosage unit, which cuts down on the amount of raw materials needed while keeping therapeutic effects the same.

Profile for Long-Acting

Formulations need to be dosed less often because their biological half-life is 36–54 hours. This helps with both patient compliance and formulation creation in the real world.

Not Much Mineralocorticoid Activity

Dexamethasone doesn't keep salt in the body as much as cortisol or prednisone do. This lowers the chance of side effects related to electrolytes, making your formulation safer.

It comes in micronized grades.

Micronized grades with D90 < 5µm or D90 < 10µm are offered for use in eye drops or suspensions. Controlling the size of the particles directly raises the rate of breakdown, the bioavailability, and the uniformity of the suspension.

Meets the standards of USP, EP, and BP

The substance meets the most important international drug standards, which supports regulatory submissions in the US, EU, and UK markets.

Dexamethasone Powder Application

1. Sterile Ophthalmic Suspension Manufacturing

Here, you need micronized grades. As the powder is mixed in a clean fluid, its low solubility in water stops the tear film from washing off quickly. This keeps the anti-inflammatory effect on the surface of the eye going for a long time. Controlling particle size (D90 < 5µm) is very important to keep the eye from getting irritated.

2. Tablets and other solid oral dosage forms

People who make medicines use the powder as the main active ingredient to make pills that are 0.5 mg, 0.75 mg, and up to 6 mg. When there is a low drug-to-excipient ratio, bulk density and powder flow qualities have a direct effect on how evenly the content is distributed on high-speed tabletting machines.

3. Making medicines for animals

Compounding pharmacies make oral powders or pastes that are specific to horses (for treating heaves or RAO) and dogs (for treating allergic dermatitis). High potency means very small amounts per dose, which makes it easier for animals to tolerate and take.

4. Formulations for injectables and skin

The powder is used to make injectable suspensions and creams that are put on the skin. For water-based injectables, the Dexamethasone Sodium Phosphate form is used. For creams that are only partly solid, co-solvents like propylene glycol help the drug mix in.

Why Choose Us?

Established producer since 2001, with 10 or more modern production lines spread out over 20,000 m²

3,000 tons of production every year, which guaranties a steady supply and on-time delivery

lab that meets SGS standards and has more than 20 R&D and quality assurance experts on site

Multiple approvals, including KOSHER, HALAL, BRC, ISO9001, ISO22000, cGMP, FSSC22000, and ORGANIC (EU & NOP).

Third-party tests by SGS and Eurofins found herbicide residues, heavy metals, and solvent residues.

Around 200 people work on quality, transportation, and customer service, and they are all responsive.

Delivery in 3–7 business days with full batch documentation

Production Process

In all stages of production, Shaanxi Hongda uses ICH Q7 GMP guidelines and works in 100,000-level purification workshops.

The process starts with getting the raw materials. Then comes chemical synthesis under controlled conditions. Next comes crystallisation and particle size control. Next comes drying and milling (including micronization when needed). Next come in-process quality checks (HPLC, GC, UV). Finally comes testing the finished product. Finally comes batch documentation and issuing a COA. Finally comes Packaging in double-layer PE bags inside fibre drums (25 kg/drum).

Traceability management checks all batches and tests for heavy metals, chemicals, microbes, and physical properties are done before they are released.

OEM / ODM Support

Pharmaceutical companies, animal product companies, and contract development organisations can get personalised service from Shaanxi Hongda.

You can change the particle size (standard or micronized grades), the way the product is packaged, and the type of product it is, such as powders, pills, capsules, or already mixed ingredients. For both domestic and international regulatory submissions, we offer private label and custom documentation support.

All customisation is done in a clean production area, and R&D staff oversee the whole process from the specifications to the delivery.

Our Exhibitions

You can meet us in these exhibition in 2026:

FAQ

Q1: Can this material be mixed with water to make liquids?

A: Not really. Dexamethasone base doesn't mix well with water. The right form of Dexamethasone is Sodium Phosphate in water for intravenous injections. For semi-solid or suspension forms, you need co-solvents like ethanol or propylene glycol.

Q2: What's the difference between grades that are micronized and marks that aren't?

A: Micronized powder is milled into particles that are usually smaller than 10µm (D90). This increases the powder's surface area, which helps it dissolve and mix evenly in solutions and eye drops. For normal tabletting, where powder flow is important, grades that aren't micronized work well.

Q3: What is the best way to store the powder?

A: Keep at controlled room temperature (25°C) in containers that can't let light in and are tightly closed. The material is sensitive to light and water, and if it is stored incorrectly, it can break down and change colour.

Q4: What controls are in place to keep impurities out?

A: The COA includes impurity profiling using HPLC according to USP/EP standards. Individual substances that are linked are limited to less than 0.5%, and full residual solvent testing is done as required by ICH Q3C.

Q5: What safe ways of handling are there?

A: Because it is a strong hormonal API (OEB 3/4), workers must wear full PPE, such as N95/P100 respirators, gloves, and special gowns, to keep it from being breathed in or absorbed through the skin.

Q6: Can you provide proof for government submissions?

A: Yes, full batch documentation is given, which includes COA, third-party test reports, MSDS, and specification sheets. If you ask, we can get you more paperwork for USP/EP regulatory files.

Contact Us

Ready to source pharmaceutical-grade corticosteroid API with Dexamethasone Powder? Send your inquiry to duke@hongdaherb.com and our team will respond within 24 hours.