99% API de succinato sódico de hidrocortisona
Succinato sódico de hidrocortisona 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.
Nuestro Hydrocortisone Sodium Succinate Bulk API se fabrica en un cGMP‑compliant facility with dedicated lines for sterile and non‑sterile processing.
¿Por qué elegirnos como su proveedor de succinato sódico de hidrocortisona?
#1. API aprobado por GMP, apto para la producción de medicamentos.
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. Pedido mínimo bajo con envío rápido.
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
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Aplicaciones:
Para fabricantes farmacéuticos
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.
Para farmacias de compuestos
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)
Nombre del producto: Hydrocortisone Sodium Succinate APIs (氢化可的松半琥珀酸钠)
Apariencia:Un polvo blanco
Solubilidad:Muy soluble en agua y DMSO.
Número CAS: 125-04-2
Fórmula molecular:C25H33NaO8
Peso molecular:484,5 g/mol
Nombre químico: Sodio; 4-[2-[(8S,9S,10R,11S,13S,14S,17R)-11,17-dihidroxi-10,13-dimetil-3-oxo-2,6,7,8,9,11,12,14,15,16-decahidro-1H-ciclopenta[a]fenantren-17-il]-2-oxoetoxi]-4-oxobutanoato
Código HS: 2937229000 (Derivados halogenados de otras hormonas adrenocorticotrópicas-其他肾上腺皮质激素的卤化衍生物)
Aptitud para ser enviados por vía aérea como mercancías comunes: Adecuado. Se puede enviar por vía aérea sin ningún problema, como si fuera una mercancía común.
Calificación: Grado farmacéutico
Pureza o Ensayo: 99%
Normas:Estándares actuales de empresa/USP
Certificados disponibles:BPF/ISO
Documentos disponibles: Certificado de autenticidad/ficha de datos de seguridad
Capacidad de suministro:50 kg al mes
Cantidad mínima de pedido:100 gramos
Plazo de entrega:3~4 días para cantidades inferiores a 5000 gramos, 4~5 días para pedidos inferiores a 20 KG.
Estado del stock:Más de 20 kg
Temperatura de envío:Temperatura ambiente
Almacenamiento: 2~8 °C (largo plazo)
Datos técnicos:
Contenido de sodio: 4.60%~4.84%
Rotación óptica específica: +140°~+150°
Pérdida por secado: NMT 2.0%
Disolventes residuales: Metanol: NMT3000ppm, Acetona: NMT5000ppm, Acetato de etilo: NMT5000ppm
Ensayo: 97,0%~102,0%
Suministramos el API de succinato sódico de hidrocortisona con certificación GMP a farmacias especializadas y fabricantes de dosis inyectables. Si busca este API para la producción farmacéutica, contáctenos.
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?
Absolutamente.
Can compounding pharmacies legally use Hydrocortisone Sodium Succinate API?
Sí.
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 hidrocortisona (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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