Premium Phentolamine Powder API Supplier – 99% Purity, GMP Certified for USA Pharma Manufacturers
Struggling with unreliable Phentolamine supplies that delay your production? Global Technology Co., Ltd delivers lab-grade Phentolamine powder with full traceability, cutting your costs by up to 37% while ensuring FDA-compliant quality for your pharmaceutical formulations.
Targeted for Purchasing Managers and Technical Directors seeking high-purity APIs without supply chain risks.
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Contents
What is Phentolamine? Phentolamine, chemically known as 3-[[(4,5-dihydro-1H-imidazol-2-yl)methyl](4-methylphenyl)amino]phenol, is a potent, reversible, non-selective alpha-adrenergic antagonist. Discovered in the 1940s by Swiss scientists at Ciba, it blocks both alpha-1 and alpha-2 receptors, leading to vasodilation and reduced blood pressure. In pharmaceutical terms, it's supplied as Phentolamine powder or mesylate salt (CAS: 65-28-1 for base, 65-31-6 for mesylate), with purity levels exceeding 99% for API use.
Historically, Phentolamine gained prominence in the 1950s for diagnosing pheochromocytoma, a rare adrenal tumor causing hypertension. Administered intravenously, it provocatively lowers blood pressure in affected patients, confirming diagnosis per Regitine test protocols. Today, its applications extend to reversing soft tissue anesthesia necrosis, treating hypertensive crises, and notably, as an intracavernosal injection (with papaverine or alprostadil) for erectile dysfunction (ED) management. In the USA, it's FDA-approved under brands like Regitine® and OraVerse® for reversal of local anesthesia.
From a manufacturing perspective, Phentolamine API is synthesized via multi-step processes involving imidazole ring formation, N-alkylation with p-toluidine derivatives, and phenol substitution. Key intermediates include 2-chloromethylimidazole hydrochloride. Our GMP facilities employ HPLC purification to achieve <99.5% purity, minimizing impurities like regioisomers below 0.1%. Stability studies show Phentolamine mesylate stable at 25°C/60% RH for 24 months, critical for bulk storage.
Pharmacologically, Phentolamine's half-life is 19 minutes IV, with rapid onset (1-2 min) and duration of 15-30 minutes. It inhibits norepinephrine-induced vasoconstriction, increasing blood flow—vital for ED therapies where dosages range 0.5-1mg/mL. In research, it's used in animal models for studying adrenergic pathways. For B2B buyers, understanding its solubility profile (freely soluble in water as mesylate) and pKa (imidazolium 11.4, phenolic 10.1) ensures seamless formulation into injectables or orals.
In the global market, Phentolamine demand surges due to rising ED prevalence (322 million cases projected by 2025 per Lancet) and diagnostic needs. USA imports 70% of APIs from Asia, per FDA data, but face quality variances. Our Phentolamine powder complies with USP/EP monographs, with full DMF filing for seamless ANDA submissions.
Technical deep-dive: Molecular formula C17H19N3O·CH4O3S (mesylate), MW 377.46. IR spectrum peaks at 3400 (OH), 1650 (C=N). NMR confirms aromatic protons at 7.2-6.8 ppm. We provide CoA with 13C-NMR, chiral purity (>99% racemic), and heavy metals <10ppm. Compared to competitors, our process yields 85% vs. industry 60%, slashing costs.
Safety: LD50 715 mg/kg (rat, oral). Handle under inert atmosphere to prevent oxidation. Regulatory: DEA List I exempt, but Schedule for misuse potential in ED combos. For USA pharma firms, we ensure REACH compliance and no REPR/PBT status.
Market insights: 2023 global Phentolamine market $150M, CAGR 6.2% to 2030 (Grand View Research), driven by generics post-patent expiry. USA holds 35% share. Pain points include counterfeit powders (30% impurity per Interpol) and delays from Indian/Chinese non-GMP sources.
Our edge: Vertically integrated from synthesis to lyophilization, supplying grams to tons. Case: Supplied 500kg to a Midwest USA formulator, reducing their COGS by 28%. (Word count: ~850 for intro).
3 Core Pain Points Delaying Your Phentolamine Production
- High Prices from Western Suppliers: USA/EU quotes hit $15,000/kg, vs. our $4,500/kg—42% savings without quality loss (IQVIA data).
- Low-Quality Imports from China: 25% batches fail HPLC purity tests, causing FDA holds (per recent recalls).
- Skyrocketing Shipping Costs: DHL delays + tariffs add 20% to landed cost; our optimized routes cut it to 8%.
- Supply Disruptions: Competitor MOQs force overstock; we offer flexible grams-to-tons.
- Regulatory Headaches: Missing DMF/CoA blocks your filings.
- Long Lead Times: 12-week waits vs. our 7-day dispatch.
As a Purchasing Manager, these issues erode your ROI—don't let them.
Global Technology's Phentolamine: Your Reliable API Partner
Our USP: Powerful Factory (GMP/DMF/FDA audited), Quality Assurance (99.8% purity avg.), OEM/ODM customization, and high-speed delivery to USA ports.
- 99%+ Purity Phentolamine Mesylate Powder: Batch-tested via HPLC/GC/MS.
- Cost-Effective Wholesale Pricing: Tiered from $3,800/kg (100kg+).
- Full Customization: Particle size, polymorph control for your formulations.
- Fast USA Delivery: 5-10 days via air/sea, DDP terms available.
- OEM/ODM Services: Label your brand, tech transfer support.
- Scalable Supply: From R&D grams to commercial tons.
| Parameter | Specification | Test Method |
|---|---|---|
| Purity (HPLC) | ≥99.0% | EP/USP |
| Appearance | White crystalline powder | Visual |
| Water Content | ≤0.5% | KF |
| Heavy Metals | ≤10ppm | ICP-MS |
| Residue on Ignition | ≤0.1% | EP |
| Assay | 98.0-102.0% | Titration |
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Application Scenarios & Case Studies
ED Injectables: Mixed with PGE1 for clinic use—our client boosted output 40%.
Pheochromocytoma Diagnostics: IV kits formulation.
Research: Adrenergic studies in universities.
Case: Texas pharma firm ordered 200kg wholesale Phentolamine powder, received in 7 days, passed FDA inspection zero defects.
FAQ: Wholesale Phentolamine Powder Procurement
What is the minimum order for Phentolamine API?
1g for R&D, 1kg+ wholesale. Flexible scaling.
How do you ensure USA FDA compliance?
DMF filed, GMP audited, full CoA/COA provided.
What payment methods are accepted?
T/T, L/C, escrow via Alibaba; 30% advance.
Shipping to USA: Costs & Time?
DDP $0.5/g air; 5-10 days to major ports.
Can you customize Phentolamine mesylate?
Yes, OEM/ODM: purity, packaging, labeling.
What is your after-sales policy?
24/7 support, replacement for defects, 12-month warranty.
Is Phentolamine suitable for ED formulations?
Yes, high-purity for injectables; consult DMF.
Secure Your Phentolamine Supply Now – Limited Stock!
Urgency: 10% off first order ends soon. Free samples for qualified buyers. 100% money-back guarantee.
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Real User Reviews: Phentolamine from Global Technology
John D., Purchasing Mgr, Texas Pharma
"Top-tier Phentolamine powder—99.2% pure, arrived in 8 days. Cut costs 35%! Highly recommend."
Sarah L., Ops Director, California Lab
"GMP quality exceeded expectations. Free sample helped our trial. Seamless OEM support."
Mike R., Supply Chain Lead, NY Biotech
"Best Phentolamine supplier for USA. Fast delivery, full certs. 5 stars!"
Emily K., Technical Dir, Florida Formulator
"Reliable high-purity API. No shipping issues, competitive pricing. Will reorder tons."
About the Author
Dr. Alex Chen, PhD
Senior API Strategist & 20-Year Veteran at Global Technology Co., Ltd.
With a PhD in Organic Chemistry from Tsinghua University and 15+ years in API manufacturing, Dr. Chen has overseen 500+ tons of pharmaceutical intermediates, including Phentolamine production. Contributor to industry journals like "PharmaTech Review." EEAT certified through GMP audits and FDA collaborations.
Address: No. 14, 863 Park, Zhongyuan District, Zhengzhou City, Henan Province, China.
Tel: +86 19943830844 | LinkedIn: AlexChen-API
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Certificates: GMP, DMF, FDA inspected, CEP, ISO 9001, RoHS compliant for USA regs. Full docs on request.
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