99% Dexamethasone Sodium Phosphate

Dexamethasone sodium phosphate is a synthetic adrenocortical steroid and the disodium salt of dexamethasone 21-phosphate. Its chemical name is 9-fluoro-11β,17-dihydroxy-16α-methyl-21-(phosphonooxy)pregna-1,4-diene-3,20-dione disodium salt. The substance occurs as a white to slightly yellow, odourless crystalline powder with a slight alcohol odour, and it is markedly hygroscopic: it absorbs moisture from ambient air and must be handled in a controlled environment.

The phosphate group is what separates this API from dexamethasone base. Dexamethasone itself is practically insoluble in water, which is why the base is used mainly in tablets, suspensions and creams. Adding the phosphate ester and forming the disodium salt raises aqueous solubility to roughly 100–1000 mg/mL, opening the door to sterile injectables, eye drops and any formulation that needs a clear, preservative-compatible aqueous phase.

A practical point that catches buyers out: pharmacopoeial labelling expresses injection strength as dexamethasone phosphate, not as the disodium salt and not as dexamethasone base. A 10 mg/mL product labelled as dexamethasone phosphate actually contains about 10.93 mg/mL of dexamethasone sodium phosphate, equivalent to 8.33 mg/mL dexamethasone. Quote and label consistently, or the receiving QC lab will reject the delivery on a technicality.

Understanding the mechanism is useful on a supplier page for one reason: it explains why the salt form exists and why formulators choose it over the base, which is exactly what a technical buyer is checking when they land here.

Receptor-Level Mechanism

Dexamethasone sodium phosphate crosses the cell membrane and binds the cytoplasmic glucocorticoid receptor. The ligand–receptor complex translocates to the nucleus and alters gene transcription: it induces lipocortin-1 and IκB, and it represses the transcription of pro-inflammatory cytokines such as IL-1, IL-6 and TNF-α. Downstream, cyclooxygenase-2 and phospholipase A2 activity falls, so fewer prostaglandins and leukotrienes are generated. At the vascular level this reduces capillary permeability and leukocyte migration, which is why oedema, redness and exudation subside quickly after parenteral administration.

Dexamethasone sodium phosphate is an active pharmaceutical ingredient, not a finished medicine. The applications below describe the dosage forms it is used to manufacture and the pharmacological profile those products rely on. Nothing on this page is medical advice or a promotion of a specific therapeutic use.

Injectable Dosage Forms

The largest volume application is injection: intravenous, intramuscular, intra-articular, intralesional and soft-tissue routes. Typical strengths are 4 mg/mL and 10 mg/mL expressed as dexamethasone phosphate. Formulators value the salt for its fast onset, its compatibility with citrate-buffered aqueous systems, and the fact that a clear solution can be terminally filtered without solubilisation aids. Products in this category are used for inflammatory and allergic conditions, cerebral oedema associated with tumour or trauma, and as adjunctive therapy in severe shock and acute exacerbations of inflammatory disease.

Ophthalmic Formulations

Eye drops and ophthalmic ointments rely on a sterile-grade or low-bioburden API together with a preservative strategy that suits the container closure. Because the phosphate salt dissolves to a clear solution at neutral-to-slightly-alkaline pH, it is well suited to multi-dose bottles and unit-dose vials. Post-operative and non-infectious inflammatory conditions are the typical target of these products. Buyers ordering for ophthalmic use should specify sterility, endotoxin and particulate requirements at the enquiry stage, as these change the manufacturing route and the price.

Topical and Dermatological Products

Creams, gels and lotions use the API at low concentrations, commonly in the 0.05–0.1% range, in an aqueous or emulsion base. The salt is easier to incorporate into the water phase than the base, which shortens development time and reduces the risk of crystal growth on stability. [Confirm the concentration range your own range covers before publishing this figure.]

Oral Liquids, Nasal and Other Dosage Forms

Oral solutions and elixirs exploit the same water solubility, and the phosphate salt is also used in nasal sprays, nebuliser solutions and iontophoresis systems. Each of these routes has its own pH and preservative constraints, so a supplier that can provide a formulation-friendly CoA and a fast technical answer is worth more than a marginally lower price.

Veterinary and Laboratory Use

The API is also used in veterinary anti-inflammatory products and as a reference standard or receptor ligand in laboratory work. For research quantities we supply gram-level packs with the same batch documentation as commercial lots, which matters for laboratories that need traceability in published work.

Monograph-grade consistency. Every lot is released against USP, EP or ChP monograph limits, and the CoA reports the actual measured values rather than a generic pass/fail sheet. If your incoming QC runs the same HPLC method, the numbers should reconcile.

Documentation built for registration. CoA, MSDS, TDS, elemental impurity assessment and TSE/BSE statements are prepared in the format regulatory affairs teams expect, so vendor qualification does not stall on missing paperwork. [Confirm which of these you can actually issue.]

Quantities that match your stage. A 100 g pack for formulation trials, a 1 kg pack for pilot batches, a 25 kg drum for commercial supply. You do not have to buy a full drum to qualify a second source.

Handling that respects a hygroscopic API. Double LDPE bags, desiccant where appropriate, and drums that survive international transit. Moisture uptake is the most common cause of a failed incoming assay, and packaging is the cheapest place to prevent it.

Export experience, not just a price list. Commercial invoice, packing list, CoA, MSDS, certificate of origin and end-use documentation are prepared as a set, so customs and your QA department receive a complete file rather than a series of follow-up emails.

A technical answer within [24] hours. Solubility, pH compatibility, CoA interpretation and packaging questions go to a technical contact, not to a generic sales inbox.

Q1. What is the difference between dexamethasone and dexamethasone sodium phosphate?

A. Dexamethasone is the base molecule, which is practically insoluble in water and used mainly in tablets, suspensions and creams. Dexamethasone sodium phosphate is the disodium phosphate ester of the same molecule; the ester raises water solubility to roughly 100–1000 mg/mL, which makes clear aqueous injectables and eye drops possible. Inside the body, phosphatases remove the phosphate group and release dexamethasone, so the intrinsic activity is the same.

Q2. Is dexamethasone sodium phosphate soluble in water?

A. Yes. It is freely soluble in water at approximately 100–1000 mg/mL, soluble in methanol, and practically insoluble in acetone and ether. A 1% aqueous solution typically shows a pH of 7.5–10.5, while commercial injection products are buffered to pH 7.0–8.5.

Q3. What assay and purity can I expect?

A. USP and EP grade material is specified at 97.0–102.0% on the anhydrous and solvent-free basis, with related substances, residual solvents and elemental impurities controlled to monograph and ICH Q3D limits. The batch CoA reports the measured values for the lot you receive.

Q4. Which pharmacopoeial grades do you supply?

A. USP-NF, EP/BP and ChP grades as standard, with other specifications available on request. Choose the grade that matches your registration dossier; switching grade mid-project usually requires a variation.

Q5. How should the powder be stored, and what is the shelf life?

A. Store in tightly closed, light-resistant containers in a dry place at ambient temperature. The API is exceedingly hygroscopic, so reseal opened containers with desiccant and work within the validated in-use period. Shelf life is stated on the batch label and CoA, typically [confirm] years from the date of manufacture.

Q6. What is the minimum order quantity?

A. Samples start at 100 g for qualification work and commercial supply is normally packed in 1 kg, 5 kg, 10 kg and 25 kg units. The commercial MOQ is [confirm]; pricing per kg improves at drum quantities.

Q7. Do you provide CoA, MSDS and TDS?

A. Yes. A batch-specific CoA accompanies every shipment, and MSDS and TDS are issued on request. For vendor qualification we can send the documentation package before the first order so your QA team can review it in parallel with sampling.

Q8. Is the material sterile, and can it be used for injectable manufacturing?

A. Standard supply is non-sterile API manufactured under GMP. Manufacturers of sterile injectables filter or terminally sterilise downstream, and we can quote a low-bioburden or sterile grade [confirm availability] if your process requires it. Endotoxin and particulate specifications should be stated at enquiry.

Q9. Can you support product registration in my market?

A. We can provide the open portion of the regulatory file, GMP certificates and stability data, and complete the supplier questionnaire your authority requires. [Confirm which markets and which documents you can actually support.]

Q10. Is this product intended for direct human consumption?

A. No. It is an active pharmaceutical ingredient for further manufacturing. It is not a finished medicine, not a dietary supplement, and must not be dispensed to patients or used for self-treatment.

Name :Serena Pang
Mobile :15667080670
We:15667080670
Whats:+8615667080670
E-mail:Serena@xaheshun.com
Best regards,
Serena Pang
Xi'an Tongze Biotech Co., Ltd.

Packaging: 25kg/bag or according to client request
Delivery Detail: 1~2 weeks after confirm order.Some of the products can be supplied within 7 days on the strength of EDC warehouse.
 

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