99% هيدروكورتيزون سكسينات الصوديوم API

What is Hydrocortisone Sodium Succinate API used for in pharmaceutical manufacturing?

Hydrocortisone Sodium Succinate API is the active ingredient in sterile injectable formulations for rapid IV/IM administration. Indications include acute adrenal insufficiency (Addisonian crisis), septic shock (as part of a combination protocol), severe allergic reactions, status asthmaticus, and high‑dose immunosuppression for organ transplantation or autoimmune disease flares. Finished products include sterile powder vials (100 mg to 1 g) for reconstitution.

Is Hydrocortisone Sodium Succinate API manufactured under cGMP?

قطعاً.

Can compounding pharmacies legally use Hydrocortisone Sodium Succinate API?

نعم.

What is the stability of Hydrocortisone Sodium Succinate API and reconstituted solutions?

Our API is stable for 36 months when stored at 2–8°C in the original sealed container, protected from light and moisture. Due to its hygroscopic nature, the container must remain tightly sealed. Reconstituted solutions (in sterile water for injection or 0.9% sodium chloride) are stable for 24 hours at room temperature and 4 days refrigerated (2–8°C). Discard any unused solution after 4 days. Extended stability data for specific diluents is available upon request.

What is your MOQ and lead time for commercial orders?

Our standard MOQ is 1000 g. For commercial quantities (10 kg+), lead time is 1–2 weeks after order confirmation. We maintain a limited safety stock of sterile grade for urgent requirements – please inquire.

Do you offer custom particle size or micronization?

Because the API is used in solution formulations (dissolved before administration), particle size is not typically critical. However, for specialized solid dosage forms (which are very rare for this salt), we can provide a custom particle-size distribution. Minimum custom batch is 1 kg.

What is the mechanism of action of Hydrocortisone Sodium Succinate?

After IV injection, the succinate ester is rapidly hydrolyzed by plasma esterases to free hydrocortisone. Free hydrocortisone binds to cytoplasmic glucocorticoid receptors, translocates to the nucleus, and modulates gene transcription – upregulating anti‑inflammatory proteins (e.g., annexin‑1) and downregulating pro‑inflammatory cytokines (e.g., IL‑1, IL‑6, TNF‑α). It also stabilizes lysosomal membranes, reduces capillary permeability, and suppresses the immune response. The sodium succinate salt ensures rapid dissolution and high peak levels within minutes.

What impurity profile should I expect?

Our API complies with the USP monograph and the Ph. Eur monograph. The most critical impurity is هيدروكورتيزون (free hydrocortisone resulting from partial hydrolysis during manufacture or storage). We control it to ≤ 2.0%. Other impurities include succinic acid‑related substances and potential genotoxic impurities from the esterification process. We screen according to ICH M7—total impurities ≤ 3.0%. Full impurity lists with retention times are included in the DMF.

Is Hydrocortisone Sodium Succinate still patent‑protected in major markets?

Basic compound patents for hydrocortisone and its esters expired decades ago. Solu‑Cortef® (Pfizer) is off‑patent in all major markets. The FDA Orange Book lists no unexpired exclusivities for hydrocortisone sodium succinate injectable powders. However, certain formulation patents (e.g., specific buffer systems, preservative combinations) may exist. Buyers are responsible for freedom‑to‑operate analysis.

How do I get a sample for formulation development?

Request a sample via the contact form. For non‑sterile grade, we ship 0.5–1 g samples within 3–5 business days. Samples are free for qualified pharmaceutical manufacturers and outsourcing facilities; you pay shipping.

What excipients are compatible with Hydrocortisone Sodium Succinate API?

The API is compatible with sterile water for injection, 0.9% sodium chloride injection, and 5% dextrose injection. For reconstitution, common buffers include sodium phosphate (monobasic/dibasic) to adjust the pH to 7–8. Avoid acidic vehicles (e.g., low-pH dextrose solutions), which can accelerate hydrolysis. Excipient compatibility data is available upon request.

Do you support veterinary applications?

Yes. Hydrocortisone sodium succinate is used in veterinary emergency medicine for Addison’s disease, anaphylaxis, and shock in dogs, cats, and horses. Our sterile grade API can be supplied with veterinary‑specific documentation. Please inquire.