99% Spironolactone API Of GMP Factory
Spironolactone is both a potassium-sparing diuretic and an anti-androgen. It helps the kidneys remove excess fluid and sodium while retaining potassium. Simultaneously, it blocks androgen receptors, which can improve hormonal skin and hair concerns.
We are a leading manufacturer and supplier of premium-grade Spironolactone API, dedicated to empowering pharmaceutical companies and compounding pharmacies with a reliable, high-quality foundation for their formulations.
We understand that your success depends on supreme Spironolactone raw materials that deliver consistent therapeutic performance. That’s why we combine state-of-the-art synthesis and deep regulatory expertise to provide a product that meets your needs, whether you are developing a new generic medication or preparing a custom-compounded medication.
Why Choose Us As Your Spironolactone Supplier
#1. Supreme Quality with GMP/CEP/FDA
Our Spironolactone API is produced in accordance with GMP, CEP, and FDA guidelines, meeting the requirements of USP, EP, and CP.
#2. Samples Available For Quality Approval:
Though the product is inexpensive, we can still arrange samples for your testing.
#3. Low MOQ:
Although our standard packing is 25kg/Drum from the GMP factory, we also offer smaller packing units, such as 1kg/tin, for your trial order.
#4. Quality Guarantee:
OCTAGONCHEM offers a full refund policy to address any quality issues that may arise.
Spironolactone API Applications and Specifications
Manufacturer Documents Download
Applications:
Our Spironolactone API serves a wide range of customers across the pharmaceutical supply chain:
Pharmaceutical manufacturers and generic drug developers – used in immediate‑release tablets (25 mg, 50 mg, 100 mg), oral suspensions, and combination products with other antihypertensives (e.g., hydrochlorothiazide).
Compounding pharmacies – custom capsule strengths (12.5 mg, 75 mg, etc.), oral suspensions (5 mg/mL – 25 mg/mL), and topical formulations for acne and hirsutism.
Hospital pharmacies and GPOs – indicated for congestive heart failure (NYHA class III‑IV), resistant hypertension, edema due to cirrhosis or nephrotic syndrome, and primary hyperaldosteronism.
Dermatology and endocrinology clinics – off‑label use for hormonal acne, female pattern hair loss, polycystic ovary syndrome (PCOS), and hirsutism.
Spironolactone is specifically indicated for:
Treatment of hypertension (as monotherapy or adjunctive therapy)
Management of edema associated with congestive heart failure, cirrhosis of the liver, and nephrotic syndrome
Diagnosis and treatment of primary hyperaldosteronism (short‑term and long‑term)
Heart failure with reduced ejection fraction (HFrEF) as adjunctive therapy to standard care
Product Name: Spironolactone APIs (螺内酯)
Appearance: A white to off-white powder
Solubility: Soluble in ethyl acetate and ethanol, slightly soluble in methanol, 22 mg/L at 25 °C in water
Cas Number: 52-01-7
Molecular Formula: C24H32O4S
Molecular Weight: 416.62 g/mol
Chemical Name: S-[(7R,8R,9S,10R,13S,14S,17R)-10,13-dimethyl-3,5′-dioxospiro[2,6,7,8,9,11,12,14,15,16-decahydro-1H-cyclopenta[a]phenanthrene-17,2′-oxolane]-7-yl] ethanethioate
HS Code: 2932999099 (Other heterocyclic compounds containing only oxygen heteroatoms-其他仅含氧杂原子的杂环化合物)
Suitability to be shipped by air/sea/rail as common goods: suitable. It is safe to be shipped by air as common goods.
Grade: Pharmaceutical Grade
Purity or Assay: 99%+ (By HPLC)
Standards: EP/USP
Manufacturer Documents Available: COA/MSDS/SDS
Manufacturer Certificates Available: GMP/WC/CEP/FDA
Supply Capability: Over 100 KG per month
MOQ: 1 KG
Lead Time: 3~4 days for quantities less than 50 KG
Stock Status: Over 200 KG
Shipping Temperature: Room temperature
Storage: Room temperature
FAQs About Our Spironolactone API
Q1: Is your Spironolactone API compliant with global pharmacopeial standards (e.g., USP, EP, JP)?
A: Yes. Our Spironolactone API is manufactured in strict accordance with USP, EP, and JP monographs, ensuring consistency with international quality benchmarks. We provide CoAs (Certificates of Analysis) for every batch, detailing compliance with these standards.
Q2:What regulatory documentation do you provide to assist with our market authorization applications?
A: We provide complete and active Drug Master File (DMF) letters of authorization for key markets, including the US (US-DMF Type II). Our product is also supported by a valid Certificate of Suitability (CEP) from the EDQM. For other regions, we can supply GMP certificates, detailed stability data, and all necessary documentation required by your local health authority (e.g., CDSCO, PMDA, MFDS)
Q3: What is the purity level of ySpironolactonetone API?
A: Our API boasts a minimum purity of 99.0% (HPLC), with strict control over impurities (e.g., related substances <0.1% as per ICH Q3A). We conduct rigorous testing, including HPLC, NMR, and mass spectrometry, to ensure purity and the absence of contaminants.
Q4: Do you provide stability studies for ySpironolactonetone API?
A: Yes. We maintain detailed stability data in accordance with ICH guidelines (accelerated and long-term conditions) to confirm shelf life (typically 36 months when stored properly). This data is available upon request for formulation development.
Q5: What is your minimum order quantity (MOQ) for bulk Spironolactone API?
A: We offer flexible minimum order quantities (MOQs). Usually, our GMP APIs start at 1 kg for standard grades, with smaller batches available for custom orders. Contact our sales team to discuss customized quantities tailored to your import needs.
Q6: What are your lead times for API delivery?
A: Standard lead times are 3–5 days for pre-stock orders. For custom batches or large volumes, we work closely with you to align timelines and minimize disruption to your supply chain.
Q7: Do you handle export documentation and logistics?
A: Absolutely. We manage all export paperwork (e.g., commercial invoices, packing lists, COAs, and certificates of origin) and partner with trusted freight forwarders to ensure timely, compliant delivery worldwide. Incoterms (e.g., FOB, CIF) can be customized to your requirements.
Q8: Is your Spironolactone API suitable for producing oral solid dosage forms (e.g., tablets, capsules)?
A: Yes. Our API is optimized for tablet compression and granulation in oral formulations. We provide technical data (e.g., flowability, compressibility) to support seamless integration into your manufacturing processes.
Q9: Can we scale up production with your API?
A: Yes. Our facility is equipped for large-scale API production, with scalable processes validated for consistency and reliability. We collaborate with you to adjust batch sizes and timelines as your production needs grow.
Q10: Do you offer technical support for formulation development?
A: Our R&D team provides end-to-end support—from pre-formulation studies (e.g., solubility, stability) to scale-up guidance. We also share process parameters (e.g., mixing times and drying conditions) to optimize your formulation.
Q11: Is your Spironolactone suitable for compounding? Our order quantity is less than 5kg per order.
A: Yes. Our Spironolactone API is a GMP-approved, pharmaceutical-grade raw material suitable for compounding to meet your requirements. Sure, if you need CEP-grade or USFDA-grade, the unit price will be higher than for the Chinese GMP grade.
Q12: Is your API suitable for sterile compounding?
A: While our standard Spironolactonetone API is non-sterile, we offer aseptic processing options for specialized compounding needs. Contact us to discuss sterile-grade specifications and validation protocols.
Q13: What packaging options are available for small-batch orders?
A: We offer flexible packaging in various sizes, including 50g, 100g, and 1kg containers, featuring tamper-evident seals and desiccants to maintain purity and potency. Larger order quantities can be packaged in drums or bulk containers upon request.
Q14: How do I request a sample or technical documentation?
A: Click “Request a Sample” on our website or email [sales@octagonchem.com] with your details (company name, intended use, and required quantity). We’ll respond within 24 hours.
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