99% Methazolamide API Of GMP Manufacturer
Methazolamide is a potent, systemic carbonic anhydrase inhibitor belonging to the sulfonamide class.
Our Methazolamide API is synthesized in a cGMP‑compliant facility with validated multistep organic synthesis, recrystallization, and purification processes. Each batch is tested for purity (≥ 98.5% by HPLC), related substances (including the sulfonamide dimer and other process impurities), residual solvents, heavy metals, and microbial limits.
For pharmaceutical manufacturers developing generic equivalents of Neptazane® (the discontinued branded product) or of Methazolamide Tablets (25 mg, 50 mg), our API is an ideal match. For compounding pharmacies preparing low‑dose oral suspensions or capsules for pediatric or veterinary use (where commercial 25 mg tablets may be difficult to split accurately), we provide the CoA, impurity profile, and excipient compatibility data required for USP <795> compliance.
Why Import Methazolamide API From Us?
#1. Pharma-Grade Methazolamide With GMP
Our Methazolamide API is manufactured in accordance with Chinese GMP standards, ensuring its suitability for pharmaceutical production and compounding. Thus, you can rest assured that this raw material meets the highest quality standards.
#2. Fast Shipment with Quick Packing
If you urgently need methazolamide raw materials, we can arrange shipment via FedEx within 3-4 days. You can expect to receive the goods within 10 days after order confirmation. Our consistent stock availability enables quick shipping, and we use GMP-compliant packaging for added quality assurance.
Methazolamide API Applications and Specifications
Manufacturer Documents Download
Applications:
For Pharmaceutical Manufacturers
Methazolamide API is formulated into oral solid dosage forms for systemic carbonic anhydrase inhibition:
Oral tablets (25 mg, 50 mg) – the standard dosage form for chronic open‑angle glaucoma and secondary glaucoma. Typical dosing is 25‑50 mg two to three times daily, titrated based on IOP response and patient tolerance.
Oral capsules (25 mg, 50 mg) – an alternative to tablets, particularly for patients with swallowing difficulties or where custom dosing is required.
Sustained‑release formulations – investigated but not widely commercialized due to the drug’s already favorable half‑life.
For Compounding Pharmacies
Methazolamide presents a valuable compounding opportunity, particularly since Neptazane® was discontinued by its original manufacturer, leaving a gap in some markets where acetazolamide is the only readily available option. Compounding pharmacies can prepare:
Pediatric oral suspensions (e.g., 5 mg/mL or 10 mg/mL) for children with glaucoma or idiopathic intracranial hypertension, using a preservative‑free suspending vehicle.
Custom‑strength capsules (e.g., 12.5 mg, 37.5 mg) for precise dose titration in patients sensitive to the 25 mg increments of commercial tablets.
Veterinary suspensions for dogs and cats with glaucoma (off‑label, but commonly prescribed).
Sugar‑free or dye‑free preparations for patients with excipient sensitivities.
Product Name: Methazolamide APIs (醋甲唑胺)
Appearance: A white to off-white crystalline powder
Solubility: Sparingly soluble in water, about 10mg/ml
Cas Number: 554-57-4
Molecular Formula: C5H8N4O3S2
Molecular Weight: 236.27 g/mol
Chemical Name: N-(3-methyl-5-sulfamoyl-1,3,4-thiadiazol-2-ylidene)acetamide
HS Code: 2934999099 (Other heterocyclic compounds-其他杂环化合物)
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: CP/USP (CP grade not for export, only USP Grade)
Manufacturer Certificates available: GMP
Manufacturer Documents Available: COA/MSDS/SDS
Supply Capability: Over 100 KG per month
MOQ: 10 KG (one standard GMP packing)
Lead Time: 3~4 days for quantities less than 50 KG
Stock Status: Over 100 KG
Shipping Temperature: Room temperature
Storage: Room temperature
Frequently Asked Qustions About Methazolamide API
1. Is Your Methazolamide API Suitable For Pharmacy Compounding?
Absolutely. Our Methazolamide is ideal for compounding:
Low Endotoxin Levels: <0.5 EU/mg, critical for injectables.
Sterile Options: Gamma-irradiated batches for ophthalmic formulations.
Technical Support: Formulation guidance from our pharmacologists.
The NMPA has approved our methazolamide API for pharmaceutical manufacturing in China.
It is GMP-grade, making it suitable for pharmacy compounding and medicine manufacturing in foreign countries.
2. Do you have DMF for Methazolamide API?
Yes, we do.
However, we can only provide DMF for commercial orders of 50 KG or more.
3. How is your GMP-Approved Methazolamide API Packed?
Our standard packing for methazolamide API is 10 kg per Tin. Please check the Tin above. It is 33CM* 33CM* 48CM.
It is sturdy enough to handle bumpy roads and reach our foreign customers.
4. Do we have to ship Methazolamide at low temperatures?
No, we don’t.
You don’t ship it at room temperature, and it has been stable for over two years in airtight containers at room temperature.
5. What quality certifications ensure the reliability of OctagonChem’s API?
Our Methazolamide API complies with USP/EP pharmacopeial standards and is produced in a GMP-certified facility.
Detailed Certificates of Analysis (CoA) and stability data are provided to ensure compliance with global regulatory requirements, mirroring the rigorous documentation practices in open-source pharmaceutical projects.
6. What technical support do you offer for formulation challenges?
Our team provides:
- Solubility data for common excipients (e.g., PEG, cellulose derivatives).
- Guidance on pH-sensitive formulations to avoid interactions.
- Regulatory support for MOH submissions, inspired by community-driven technical assistance models.
7. Are bulk order discounts available for your Methazolamide API?
We offer volume-based pricing and flexible payment terms for long-term contracts.
Contact our sales team for tailored quotes.
8. How are impurities controlled in your Methazolamide API?
We employ HPLC-UV/LC-MS for impurity profiling, ensuring that the total impurity content remains < 0.5% (ICH-compliant).
Process validation data is shared upon request, reflecting rigorous quality control akin to issue-tracking systems in software development.
9. Can you provide client references from the compounding sector?
We’ve supplied Methazolamide API to 5+ compounding pharmacies in North America and Europe.
Case studies and testimonials are available under NDAs, similar to feedback mechanisms in collaborative platforms.
10. Can You Customize Methazolamide API for Specific Formulations?
We offer tailored solutions for compounding pharmacies:
Particle Size Optimization: Micronized (D90 <50µm) for enhanced solubility in oral suspensions.
Excipient Compatibility: Pre-formulation studies for compatibility with standard binders (e.g., lactose, PVP).
Packaging: We offer bulk quantities (25 kg drums) or smaller batches (1–5 kg) in moisture-resistant packaging.
11. How Do You Ensure Supply Chain Reliability?
Dual Sourcing: Partnerships with multiple raw material suppliers to prevent shortages.
Inventory Management: Safety stock maintained for high-demand regions (EU, North America).
Logistics: Temperature-controlled shipping (15–25°C) with real-time tracking via DHL/FedEx.
12. What Are the Lead Times for Methazolamide API Orders?
Standard Orders: 5~7 days (ex-works) for batches ≤50 kg.
Urgent Requests: Expedited processing (3~4 days) by FedEx route.
13. How Do You Handle Quality Disputes or Returns?
Free Resampling: If the specifications are not met, we reship at no cost.
Third-Party Testing: Collaborate with independent labs (e.g., Eurofins) for unbiased verification.
14. How Does Your Methazolamide API Compare to Competitors?
Purity Advantage: 99.5% vs. industry average of 98.5%.
Cost Efficiency: 20% lower pricing than EU-based suppliers.
Regulatory Support: Full DMF access vs. competitors’ documentation.
15. Can Methazolamide API Be Used in Clinical Trials?
Yes. We supply research-grade batches with:
GMP-Equivalent Quality: Suitable for Phase I–III trials.
Custom Synthesis: Deuterated analogs for pharmacokinetic studies.
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