API di succinato di sodio idrocortisone 99%
Succinato di sodio idrocortisone is the water‑soluble hemisuccinate ester of the natural glucocorticoid hydrocortisone (cortisol).
Unlike hydrocortisone, the sodium succinate salt dissolves readily in water, enabling intravenous and intramuscular administration for rapid, high‑peak plasma concentrations. This makes it the drug of choice for acute adrenal insufficiency (Addisonian crisis), septic shock, severe allergic reactions, asthma exacerbations, and high‑dose immunosuppression.
Nostro Hydrocortisone Sodium Succinate Bulk API è prodotto in un cGMP‑compliant facility with dedicated lines for sterile and non‑sterile processing.
Perché sceglierci come fornitore di succinato di sodio idrocortisone?
#1. API approvato GMP adatto per la produzione di medicinali
If you are a compounding pharmacy owner or a medicine manufacturer and are looking for GMP-approved APIs for compounding or medicine production, you are in the right place.
Our hydrocortisone succinate sodium is registered with the Chinese SFDA and has a GMP certificate.
#2. Quantità minima d'ordine bassa con spedizione rapida
Our standard packing is 1 KG, but if you only need 100g for compounding, no problem; we will repack accordingly and ship your goods within 3~4 days after your PO confirmation.
Hydrocortisone Sodium Succinate API Applications and Specifications
Scarica i documenti del produttore
Applicazioni:
Per i produttori farmaceutici
Use our Hydrocortisone Sodium Succinate API in finished dosage forms:
Sterile injectable powders (100 mg, 250 mg, 500 mg, 1 g vials) – the standard format for IV/IM administration in acute adrenal insufficiency, septic shock, and severe asthma.
Reconstituted solutions for continuous infusion – for critical care settings requiring prolonged glucocorticoid support.
Multi‑dose presentations (with preservative) – for hospital pharmacies where repeated small doses are needed.
The API is formulated with a buffer system (usually sodium phosphate or dibasic sodium phosphate) to achieve a pH of 7–8 after reconstitution.
Per le farmacie specializzate in preparazioni galeniche
Prepare patient‑specific sterile preparations when commercial products are unavailable or customized dosing is required:
Pediatric adrenal crisis kits (e.g., 50 mg vials reconstituted for low body weight)
Veterinary IV solutions for dogs and cats with Addison’s disease or severe inflammation
Alternative buffers or preservative‑free formulations for patients with sensitivity to commercial excipients
Bulk sterile solutions for hospital pharmacy batch preparation (where permitted by state law)
Nome del prodotto: Hydrocortisone Sodium Succinate APIs (氢化可的松半琥珀酸钠)
Aspetto: Una polvere bianca
Solubilità: Molto solubile in acqua e DMSO.
Numero CAS: 125-04-2
Formula molecolare: C25H33NaO8
Peso molecolare: 484,5 g/mol
Nome chimico: Sodio; 4-[2-[(8S,9S,10R,11S,13S,14S,17R)-11,17-diidrossi-10,13-dimetil-3-osso-2,6,7,8,9,11,12,14,15,16-decaidro-1H-ciclopenta[a]fenantren-17-il]-2-ossoetossi]-4-ossobutanoato
Codice HS: 2937229000 (Derivati alogenati di altri ormoni adrenocorticotropi-其他肾上腺皮质激素的卤化衍生物)
Idoneità alla spedizione aerea come merce comune: adatto. Può essere spedito per via aerea come merce comune.
Grado: Grado farmaceutico
Purezza o analisi: 99%
Standard: Standard aziendali/USP attuali
Certificati disponibili: GMP/ISO
Documenti disponibili: Certificato di autenticità/Scheda di sicurezza
Capacità di fornitura: 50 kg al mese
Quantità minima d'ordine: 100 grammi
Tempi di consegna: 3~4 giorni per quantità inferiori a 5000 grammi, 4~5 giorni per ordini inferiori a 20 kg.
Stato delle scorte: Oltre 20 KG
Temperatura di spedizione: Temperatura ambiente
Magazzinaggio: 2~8 °C (a lungo termine)
Dati tecnici:
Contenuto di sodio: 4,60%~4,84%
Rotazione ottica specifica: +140°~+150°
Perdita all'essiccazione: NMT 2.0%
Solventi residui: Metanolo: NMT3000ppm, Acetone: NMT5000ppm, Acetato di etile: NMT5000ppm
Dosaggio: 97,0%~102,0%
Forniamo un API di idrocortisone succinato sodico approvato GMP a farmacie specializzate in preparazioni galeniche e produttori di iniezioni farmaceutiche. Contattateci se state cercando questo API per la produzione farmaceutica.
FAQs About Our Hydrocortisone Sodium Succinate 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?
Assolutamente.
Can compounding pharmacies legally use Hydrocortisone Sodium Succinate API?
SÌ.
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 idrocortisone (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.
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