Injection Sodium Acetate Trihydrate

Injection Sodium Acetate Trihydrate - Pharmaceutical Grade Acetate Solution

SHANXI ZHAOYI CHEMICAL CO., LTD brings over 35 years of acetate manufacturing excellence to your pharmaceutical operations. Our Injection Sodium Acetate Trihydrate meets USP, EP, and JP pharmacopoeial standards with guaranteed purity ≥99.5% and strict elemental impurity control. Produced in our 27,000 m² GMP-compliant facility with 150,000-ton annual capacity, this pharma-grade product features aluminum content <0.2 µg/g for dialysis safety. Each batch is rigorously tested for pH (7.5-9.0), heavy metals (Pb ≤0.001%, As ≤0.0002%), and readily oxidizable substances. Trusted by hospitals and biopharmaceutical manufacturers worldwide, our crystalline trihydrate delivers consistent buffering performance in IV formulations, TPN solutions, and dialysis concentrates.

Key Features & Benefits

Our pharmaceutical-grade product delivers 17 mEq/g sodium ions with exceptional water solubility (1g dissolves in just 0.8mL water). You get transparent colorless crystals with molecular weight 136.08 g/mol and precise chemical stability.

The strict quality controls ensure your formulations remain contamination-free. With iron content ≤0.0003% and calcium ≤0.025%, you avoid unwanted precipitation in sensitive IV admixtures and dialysis solutions.

Your production benefits from our reliable supply chain and ISO, KOSHER, and HALAL certifications. The product maintains consistent performance across batches, reducing your quality control burden and production downtime.

Technical Specifications

How It Works?

When dissolved in aqueous solutions, the compound dissociates into sodium ions and acetate ions. The acetate portion functions as a metabolizable anion that your patients' bodies convert to bicarbonate through the Krebs cycle.

This metabolic conversion corrects acidosis without the chloride load associated with sodium chloride solutions. Your clinical teams appreciate this advantage in patients requiring chloride restriction or those at risk of hyperchloremic metabolic acidosis.

The buffering capacity stabilizes pH in complex formulations. In dialysis concentrates, it prevents calcium and magnesium precipitation that could otherwise block dialysis membranes and compromise patient safety during treatment sessions.

 

Our Factory

 

30-YEAR ACETATE SPECIALIST | Non-caking, High Purity, Global Supply Chain

our factory

factory workshop

our laboratory

Applications

Hemodialysis and Peritoneal Dialysis Solutions: You can define corrosive concentrates with certainty knowing our ultra-low aluminum detail ensures dialysis patients from collection harmfulness. The item anticipates salt precipitation in bicarbonate-based circuits.

Total Parenteral Sustenance (TPN): Your healing center drug store can securely compound TPN arrangements for neonates and ICU patients. It gives fundamental sodium for electrolyte adjust whereas rectifying metabolic acidosis through acetic acid derivation metabolism.

Biopharmaceutical Manufacturing: Pharmaceutical companies utilize it as a buffering operator amid biologics refinement and peptide sedate detailing. The negligible follow metal substance anticipates catalytic debasement of your costly dynamic pharmaceutical ingredients.

IV Liquid Additives: You get a flexible component for custom IV admixtures when standard saline arrangements are contraindicated. It bolsters liquid administration in patients with complex acid-base clutters.

Injection Sodium Acetate Trihydrate vs Other Products

Certifications & Compliance

Our fabricating office holds ISO 9001:2015 quality administration certification, guaranteeing steady generation measures. We've earned Legitimate and HALAL certifications to serve differing worldwide markets and devout requirements.

The item adjusts to Joined together States Pharmacopeia (USP), European Pharmacopoeia (EP), and Japanese Pharmacopoeia (JP) monographs. Each generation bunch experiences testing against ICH Q3D rules for essential impurities.

Our quality administration framework incorporates approved explanatory strategies, prepared work force, and comprehensive documentation. You get Certificates of Investigation with each shipment appearing full compliance with indicated parameters.

 

 

 

 

 

 

Packaging Options

We offer 25kg plastic woven bags with pharmaceutical-grade internal liners for standard clinic and compounding drug store operations. These moisture-resistant bundles ensure item judgment amid capacity and handling.

For large-scale biopharmaceutical fabricating, our 1000kg ton-bags reduce taking care of recurrence and defilement hazard. These enormous packs include sterile inward liners with secure closures and printed pharmaceutical excipient labeling.

All bundling incorporates part numbers, fabricating dates, expiry dates, and capacity enlightening. The aluminum-plastic composite development avoids dampness entrance and bacterial defilement all through the 24-month rack life.

Manufacturing Process

Our production begins with high-purity acetic acid and sodium hydroxide sourced from certified pharmaceutical-grade suppliers. The neutralization reaction occurs under controlled temperature and pH monitoring in jacketed stainless steel reactors.

Crystallization takes place in temperature-controlled vessels where we carefully control cooling rates. This precision yields consistent crystal size distribution and optimal trihydrate formation for pharmaceutical applications.

The crystals undergo multiple washing cycles with purified water to remove residual impurities. Centrifugal separation removes wash water before controlled drying in clean-room dryers maintains the Injection Sodium Acetate Trihydrate structure.

Final milling and screening ensure uniform particle size. Our quality control laboratory tests every batch for all 13 specifications before packaging in our GMP-compliant clean room environment.

 

Shipment

 

Maritime Transport

Air transport

Land transportation​

Why Choose Us?

Legacy and Scale: Since 1988, we've specialized solely in acetic acid derivation chemistry. Our 150,000-ton yearly capacity implies you never confront supply intrusions indeed amid top request periods.

Quality Obsession: We keep up pharmaceutical benchmarks over our whole generation line, not fair in committed pharma clumps. This consistency gives you peace of intellect with each order.

Technical Support: Our group of chemical engineers and drug specialists gives detailing help. We offer assistance you optimize your forms and troubleshoot any application challenges you encounter.

Global Reach: With set up conveyance systems over Europe, America, and Asia, we convey dependably wherever your offices work. Our trade involvement guarantees smooth traditions clearance and documentation.

Flexible Service: Whether you require 25kg trial amounts or bulk ton-bag shipments, we suit your arrange measure. Our customer-first reasoning implies responsive communication and adjustment to your particular necessities.

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FAQ

Q: What makes your product suitable for dialysis applications?

A: Our ultra-low aluminum specification (<0.2 µg/g) prevents aluminum accumulation in dialysis patients. The high purity also ensures calcium and magnesium compatibility, preventing dangerous precipitate formation in dialysis concentrates.

Q: How does acetic acid derivation vary from bicarbonate in IV solutions?

A: Acetic acid derivation changes over to bicarbonate through ordinary digestion system, giving buffering without the solidness issues of bicarbonate arrangements. It too maintains a strategic distance from chloride over-burden related with sodium chloride-based products.

Q: Can this item be utilized in neonatal formulations?

A: Yes, the strict overwhelming metal controls (particularly lead and arsenic) and nonappearance of destructive pollutions make it suitable for pediatric and neonatal TPN details when endorsed by physicians.

Q: What is the rack life after opening the package?

A: Once opened, utilize the item inside 12 hours and reseal quickly to avoid dampness retention and defilement. Unopened bundles keep up full determinations for 24 months when put away properly.

Q: Do you give Certificates of Investigation with shipments?

A: Each group ships with a total Certificate of Examination appearing test comes about for all 13 details. We too give Medicate Ace Records (DMF) for administrative entries upon request.

Q: What capacity conditions are required?

A: Store in a dry, ventilated distribution center at temperatures underneath 30°C with relative stickiness ≤60%. Keep absent from harmful substances, oxidizers, and solid odors. Dodge dampness presentation amid transportation.

Q: Is the item congruous with mechanized compounding systems?

A: The uniform precious stone estimate and amazing water dissolvability make it perfect for computerized drug store compounding frameworks. It breaks down rapidly and totally without filtration issues.

Q: Can you supply documentation for FDA sedate ace record submissions?

A: We give comprehensive specialized documentation counting fabricating prepare depictions, quality control methods, solidness information, and pollution profiles to back your administrative filings.

Request a Quote

Ready to secure pharmaceutical-grade Injection Sodium Acetate Trihydrate for your formulations? Contact our technical sales team at sxzy@sxzhaoyi.com for customized quotes, samples, and regulatory documentation.