99% 히드로코르티손 나트륨 숙시네이트 API
히드로코르티손 나트륨 숙시네이트 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.
우리의 Hydrocortisone Sodium Succinate Bulk API is manufactured in a cGMP‑compliant facility with dedicated lines for sterile and non‑sterile processing.
왜 저희를 히드로코르티손 나트륨 숙시네이트 공급업체로 선택해야 할까요?
#1. 의약품 생산에 적합한 GMP 승인 API
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. 최소 주문 수량, 빠른 배송
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
제조업체 문서 다운로드
응용 프로그램:
제약 제조업체를 위한 정보
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.
조제 약국용
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)
제품명: Hydrocortisone Sodium Succinate APIs (氢化可的松半琥珀酸钠)
모습: 흰색 가루
용해도: 물과 DMSO에 잘 녹습니다.
CAS 번호: 125-04-2
분자식: C25H33NaO8
분자량: 484.5g/mol
화학명: 나트륨;4-[2-[(8S,9S,10R,11S,13S,14S,17R)-11,17-디하이드록시-10,13-디메틸-3-옥소-2,6,7,8,9,11,12,14,15,16-데카하이드로-1H-사이클로펜타[a]페난트렌-17-일]-2-옥소에톡시]-4-옥소부타노에이트
HS 코드: 2937229000(기타 부신피질자극호르몬의 할로겐화유도체-其他肾上腺皮质激素的卤化衍生物)
일반 물품으로서 항공 운송에 적합: 적합합니다. 일반 물품처럼 항공 운송이 안전합니다.
등급: 제약 등급
순도 또는 검정: 99%
표준: 현재 엔터프라이즈/USP 표준
사용 가능한 인증서: GMP/ISO
사용 가능한 문서: COA/MSDS
공급 능력: 한 달에 50KG
최소주문수량: 100그램
리드타임: 5000그램 미만 주문 시 3~4일, 20KG 미만 주문 시 4~5일이 소요됩니다.
재고 현황: 20KG 이상
배송 온도: 실온
저장: 2~8 °C (장기)
기술 데이터:
나트륨 함량: 4.60%~4.84%
특정 광학 회전: +140°~+150°
건조감량: NMT 2.0%
잔류 용매: 메탄올: NMT3000ppm, 아세톤: NMT5000ppm, 에틸 아세테이트: NMT5000ppm
분석: 97.0%~102.0%
저희는 GMP 승인을 받은 히드로코르티손 숙시네이트 나트륨 API를 조제 약국 및 주사제 제조업체에 공급합니다. 제약 생산용 API를 찾고 계시다면 언제든지 문의해 주세요.
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?
전적으로.
Can compounding pharmacies legally use Hydrocortisone Sodium Succinate API?
예.
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 히드로코르티손 (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.
당신이 좋아할 수 있는 다른 분자들
