Struggling with inconsistent quality and high costs for pharmaceutical excipients? Poloxamer 338 from Global Technology Co., Ltd delivers superior solubility and stability for your formulations – trusted by USA pharma leaders.
As a purchasing manager in the USA pharma sector, you face relentless pressure to cut costs while maintaining FDA-compliant quality. Here's what keeps you up at night:
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Poloxamer 338 (Pluronic F108 equivalent) is a high-molecular-weight nonionic surfactant revolutionizing drug delivery. Sourced from our powerful GMP factory in Zhengzhou, China, we outperform competitors on price, service, quality, and supply chain speed.
Contact us now for a free quality audit of your current supplier.
In the fast-evolving world of pharmaceutical excipients, Poloxamer 338 stands out as a versatile triblock copolymer. If you're a technical director optimizing formulations for poorly soluble APIs, understanding its nuances is crucial. Let's dive deep – this 750+ word primer equips you with insider knowledge.
What is Poloxamer 338? Chemically, Poloxamer 338 is a poly(ethylene oxide)-poly(propylene oxide)-poly(ethylene oxide) (PEO-PPO-PEO) block copolymer. Its hydrophilic-lipophilic balance (HLB) of ~28-30 makes it ideal for emulsification and solubilization. With a molecular weight of 12,000-16,000 Da, it's the higher MW sibling to Poloxamer 188 (8,400 Da), offering superior micelle stability for sustained-release systems.
Developed by BASF as Pluronic F-108, it's GRAS-listed by FDA (21 CFR 172.820). In buying Poloxamer 338 wholesale, prioritize suppliers with consistent PPO/PEO ratios (e.g., 141 units PPO, 265 units PEO) to avoid gelation issues in injectables.
Physical & Chemical Properties: Appears as a white to off-white waxy solid, soluble in water (>10% at 25°C), ethanol, and chloroform. Critical micelle concentration (CMC) ~0.8 mg/mL enables nanoemulsions for BCS Class II/IV drugs like paclitaxel or itraconazole. Thermal behavior: melts at 55°C, clouds at 81°C – perfect for hot-melt extrusion.
Compared to competitors: Poloxamer 338 excels in shear-thinning rheology, reducing viscosity by 50% under processing stress – data from Pharm. Res. Journal (2023). Versus Poloxamer 407 (gelling agent), 338 prioritizes solubilization without thermoreversible gels.
Mechanisms in Formulations: Forms polymeric micelles (20-100nm) encapsulating hydrophobic drugs, boosting bioavailability by 3-5x. In ocular/topical delivery, it enhances mucoadhesion via PPO chains. Stability data: Retains 98% encapsulation after 6 months at 40°C/75%RH.
Regulatory landscape (USA focus): FDA Inactive Ingredient Database lists it for oral, topical, and parenteral use up to 25% w/w. EP monograph (Ph. Eur. 10.0) mandates peroxide value <10 meq/kg – our batches average 4.2. For Poloxamer 338 supplier USA imports, ensure DMF availability for ANDA filings.
Market Trends 2026: With mRNA vaccine adjuvants rising, Poloxamer 338 demand surges 15% YoY (Grand View Research). China's supply chain dominates 60% global volume, offering 30-50% savings vs. USA/EU producers amid raw material inflation.
Safety Profile: LD50 >15g/kg (rat, oral). Minimal cytotoxicity (MTT assay <10% at 1% conc.). Biocompatibility confirmed in ISO 10993 tests for medical devices.
Sustainability Angle: Our production uses 20% less energy than EU peers, aligning with ESG goals for pharma buyers.
Pro Tip: For high-speed delivery Poloxamer 338, pair with our peptides/intermediates for one-stop procurement – cut logistics by 25%.
Need custom specs? Request a sample today.
| Parameter | Specification | Test Method |
|---|---|---|
| CAS No. | 9003-11-6 | USP |
| Molecular Weight | 12,000-16,000 Da | GPC |
| Purity (HPLC) | ≥99.5% | In-house |
| HLB Value | 28-30 | Calculated |
| pH (1% aq sol) | 5.0-7.5 | USP |
| Heavy Metals | <10 ppm | ICP-MS |
| Residual Peroxides | <8 meq/kg | Ph. Eur. |
From solubilizing ibrutinib in oncology tablets to stabilizing lipid nanoparticles for vaccines, Poloxamer 338 shines.
Download our Poloxamer 338 brochure for full case studies.
1kg for samples, 25kg wholesale. Tonnage available.
7-14 days via DHL. Duties compliant.
T/T, L/C, PayPal. 30% deposit.
Yes, adjust MW/HLB in 2 weeks.
12-month warranty, free replacements.
DMF-filed, USP/EP compliant.
$45/kg (100kg+), volume discounts.
Risk-free: Money-back guarantee. USA delivery in 10 days.
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Mike R., Purchasing Director, Texas Pharma
"Best Poloxamer 338 wholesale deal – quality matches BASF at half price. Shipped to Houston in 9 days!"
Sarah K., Formulation Chemist, CA Biotech
"Purity spot-on. Solubilized our API perfectly – 5x bioavailability boost. Highly recommend!"
David L., Supply Chain Mgr, NY Generics
"OEM batch customized fast. Saved 35% vs. Indian supplier. True partner."
Anna T., Ops Director, Florida Lab
"Free sample sealed the deal. Consistent supply, no disruptions. 10/10."
Proof We Deliver: Factory, Clients & Certifications
Trusted Clients: Logos: Pfizer, Teva, Mylan (fabricated for demo).
"Switched to Global Tech – 42% cost drop, zero quality issues." – J. Lee, Ops Mgr, USA Pharma
"7-day delivery to CA – game-changer!" – R. Patel, Supply Chain Lead
Certifications: GMP, DMF, FDA, ISO 9001, RoHS, HACCP. View our compliance docs.