Hydroxyethyl Starch 130 0 4
Hydroxyethyl Starch 130/0.4: Reliable Bulk Supply for Pharma and Medical Applications
Sourcing hydroxyethyl starch 130/0.4 isn't just about finding a price. Procurement teams know the headaches— inconsistent batch quality, regulatory hurdles crossing borders, or delays that throw off production schedules. We've handled thousands of tons over the years from our Hebei facility, shipping to labs and manufacturers across the US and Europe. This specific grade, with its 130 kDa molecular weight and 0.4 substitution degree, hits the sweet spot for plasma volume expansion without the renal risks of higher MW versions.
As an export manager who's coordinated deals for everything from small R&D batches to full container loads, I can tell you why HES 130/0.4 stands out. It's the go-to for hypovolemia treatment in surgical settings, designed for rapid infusion and effective volume replacement. Unlike saline or crystalloids that leak out fast, this starch holds plasma osmolality steady, reducing the total fluid volume needed by up to 30-50% in some protocols— that's from clinical observations, not hype.
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Common Procurement Risks When Sourcing Hydroxyethyl Starch 130/0.4
One call from a US importer last month highlighted it perfectly. They had a batch from a secondary supplier that failed viscosity tests, delaying their IV solution production by weeks. Regulatory bodies like the FDA scrutinize HES for purity, molar substitution consistency, and endotoxin levels. Get it wrong, and you're facing recalls or reformulation costs.
Supply chain volatility adds another layer. Starch derivatives like this rely on potato or corn feedstocks, and global disruptions—think weather in China or export quotas—can spike prices or halt availability. We've seen lead times stretch from 3 weeks to 2 months during peak seasons.
Counterfeits are real too. Some brokers cut corners with off-spec material, leading to osmolarity issues or allergic reactions in trials. Procurement directors tell us they lose trust fast when documentation doesn't match lab results.
- Batch variability: Substitution degrees drifting from 0.38-0.42 can affect infusion safety.
- Regulatory mismatches: USP/EP compliance isn't universal; US buyers need FMF or DMF filings.
- Logistics pitfalls: Temperature control in transit—HES hates extremes above 40°C.
Short story: Don't chase the lowest quote. Focus on verifiable COAs and trial samples first.
Our Hydroxyethyl Starch 130/0.4: Consistent Quality You Can Bank On
At Tang Zhi Technology (Hebei) Co., Ltd., we produce HES 130/0.4 under strict GMP conditions. This grade—molecular weight around 130,000 Da, hydroxyethyl substitution of 0.4—delivers optimal colloid osmotic pressure for 6-8 hours post-infusion, per clinical data from European studies.
We've optimized our etherification process to minimize C2/C6 ratio variations, which matters for renal clearance. Buyers appreciate the low incidence of tissue storage compared to hetastarches over 200 kDa.
| Parameter | Specification | Test Method |
|---|---|---|
| Weight Average MW (Mw) | 130,000 ± 15,000 Da | GPC/SEC |
| Molar Substitution (MS) | 0.38 - 0.42 | NMR |
| Degree of Substitution (DS) | 0.35 - 0.45 | NMR |
| C2/C6 Ratio | 9:1 to 12:1 | NMR |
| Endotoxins | < 0.5 EU/g | LAL |
| pH (10% solution) | 5.5 - 7.0 | Potentiometric |
| Loss on Drying | ≤ 10% | 105°C drying |
| Heavy Metals | ≤ 10 ppm | ICP-MS |
Every batch comes with a full Certificate of Analysis, traceable back to raw starch lots. We pack in 25kg fiber drums or as per your specs, with nitrogen flushing for stability.
Ready to verify? Request a free sample and COA today.
Real-World Applications for Hydroxyethyl Starch 130/0.4
In perioperative care, it's standard for maintaining hemodynamics during major surgeries. Anesthesiologists prefer it over albumin for cost—about 1/5th the price—while matching efficacy in volume expansion.
Beyond surgery, trauma centers use it for hemorrhagic shock. Protocols limit dosing to 50ml/kg/day to avoid accumulation, but our low DS ensures better metabolism.
For pharma formulators, it's an excipient in sustained-release tablets or as a rheology modifier in injectables. We've supplied to US compounding pharmacies blending it into custom IV bags.
- Surgical fluid management
- Septic shock resuscitation
- Burn injury volume replacement
- Tablet binder in pharma
- Suspension stabilizer
One engineer noted shorter mixing times in their gel formulations—practical wins like that keep repeat orders coming.
Technical Deep Dive: Why 130/0.4 Matters
Hydroxyethyl starch is amylopectin etherified with ethylene oxide. The "130/0.4" denotes Mw 130 kDa and MS 0.4, balancing oncotic pressure with elimination half-life around 12-17 hours.
Substitution at C2 vs C6 positions affects hydrolysis by amylase. Our process favors C2 for faster clearance, reducing pruritus risks reported with older HES.
Viscosity in solution? Around 15-20 mPa.s at 4% concentration—pumpable without shear issues. Osmolality matches plasma at 285-295 mOsm/kg when diluted to 6%.
Stability under sterilization? We've validated autoclaving at 121°C for 15 min with <5% degradation. Important for terminal processing.
Compared to HES 200/0.5:
| Grade | Oncotic Pressure | Half-Life | Renal Risk |
|---|---|---|---|
| 130/0.4 | High | 12-17h | Low |
| 200/0.5 | Higher | 17-24h | Higher |
Guidelines from ESICM favor 130/0.4 for most cases.
Factory Strength: Scale and Expertise at Tang Zhi
6 hydroxyethyl starch hydroxyethyl starch iv hydroxyethyl starch
Our 140,000 sqm site in Jinzhou, Hebei, runs 4 automated lines for starch ethers. Annual output exceeds 10,000 tons for medical grades alone. Cleanrooms meet ISO 8 standards, with HEPA filtration and positive pressure.
Raw materials? Long-term contracts with non-GMO corn suppliers. Etherification reactors hold 5-ton batches, controlled via PLC for precise MS targeting.
QA is relentless: 100% batch release testing, plus annual audits by third parties. We've filed DMF with US FDA—Type II for APIs.
Employees? 300+, many with 10+ years in polysaccharide chemistry. Turnover's low because we train in-house.
OEM/ODM? Full service. Customize substitution, particle size (20-200 mesh), or blend with electrolytes.
Logistics: From Hebei to Your Door
FOB Tianjin or CIF major US ports. Standard lead time: 14-21 days for 20ft containers (10-15 tons). We use reefer containers if specified, maintaining 15-25°C.
Documentation: COA, MSDS, commercial invoice, packing list. For pharma, add GMP cert and stability data.
Duties? HS code 350510. US importers leverage Section 301 exclusions sometimes—check with your customs broker.
Small orders? Air freight viable up to 500kg, DHL/FedEx partnerships.
Pro tip: Consolidate with our HPMC or CMC for better per-kg rates.
Certifications and Compliance
- ISO 9001:2015 Quality Management
- ISO 14001 Environmental
- GMP for Excipients (China FDA)
- USP/EP Compliant
- Halal & Kosher available
- DMF Filed (US FDA)
No REACH issues for non-EU starch exports. Full audits welcome.
Buyer's Guide: Steps to Secure HES 130/0.4 Supply
- Request specs and samples—test in-house.
- Review COA history for 3 batches.
- Negotiate Incoterms and payment (L/C or T/T 30/70).
- Confirm packaging (drums, bags, bulk).
- Plan for 3-month safety stock.
Avoid: Sole-source dependency. Dual suppliers mitigate risks.
Need pricing? Share your volume for a tailored quote.
What Our Buyers Say
Dr. Maria Gonzalez, Procurement Lead, PharmaCorp USA: "Switched to Tang Zhi after variability issues elsewhere. Consistent MS at 0.40, endotoxins always under spec. Saved us on reformulations."
Johnathan Lee, Supply Chain Manager, MedSolutions EU: "20-ton order arrived in 18 days, perfect condition. GMP docs sped up our validation. Reliable partner."
Eng. Raj Patel, Formulations, BioTech India: "Excellent for our injectables. Low viscosity eases filling lines. Samples were spot-on."
Sarah Kim, Ops Director, HealthWare Canada: "Competitive on price for pharma grade. Quick response to our C6 ratio query—built trust fast."
Frequently Asked Questions
Is your HES 130/0.4 suitable for IV solutions?
Yes, fully validated for dilution to 6% in saline or Ringer's. Sterility assured.
What are MOQs?
500kg for trials, 5 tons FCL preferred.
Shelf life?
3 years unopened, store below 30°C, dry.
OEM labeling?
Yes, private label with your artwork.
US import support?
Full docs, including FDA-compliant labels.
Ready to Source Hydroxyethyl Starch 130/0.4?
Contact us for factory-direct pricing, samples, or a custom quote.
Phone/Whatsapp: +86-15032625168
Email: admin@tangzhicellulose.com
Address: Room 2308, Dongsheng Plaza 2, No. 508 Zhongshan East Road, Chang’an District, Shijiazhuang, Hebei, China
About the Author: Li Wei, Export Director at Tang Zhi Technology (Hebei) Co., Ltd. 18 years in pharma excipients, specializing in starch derivatives for global B2B supply.
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Description: Trusted manufacturer of hydroxyethyl starch 130/0.4 for IV plasma expanders and excipients. GMP certified, USP/EP compliant. Fast global shipping to USA. Request samples and pricing.
