USP / EP Grade Sodium Acetate Anhydrous
CAS NO.: 127-09-3
Molecular Formula: CH₃COONa
Molecular Weight: 82.03 g/mol
Character: White crystalline powder, readily soluble in water and slightly soluble in alcohol. Its aqueous solution is mildly alkaline.
Quality Standard: The product can be manufactured and tested according to applicable USP or European Pharmacopoeia requirements. The exact specification should be confirmed by the current pharmacopoeial monograph and the supplied certificate of analysis.
Usage: Used as a pharmaceutical excipient, buffering agent, pH regulator, electrolyte component, laboratory reagent, and raw material for pharmaceutical and biochemical preparations.
Package: 25 kg fiber drum, paper bag, or plastic woven bag with a pharmaceutical-grade inner polyethylene liner.
Storage: Store in a tightly closed container in a clean, dry, and well-ventilated area. Protect from moisture, contamination, heat, and incompatible substances.
- Product Description
USP / EP Grade Sodium Acetate Anhydrous – Pharmaceutical Excellence for Critical Applications
Since 1988, SHANXI ZHAOYI CHEMICAL CO., LTD has followed strict rules for pharmaceutical production. Our USP / EP Grade Sodium Acetate Anhydrous is made to those same rules. Every lot we ship matches the official monograph standards of the USP and the European Pharmacopeia. Our plant covers 27,000 ㎡ of GMP-standard ground. It turns out 150,000 tons a year. This crystalline powder is anhydrous and very pure. Purity runs above 99.5%. Moisture stays under 0.5%. Heavy metals are limited to 0.001%. Drug makers use it as an excipient. It works as a pH regulator too. Buffering is another job it does. Across the world, it goes into demanding drug work: biochemical reagents, injectable preparations, and dialysis solutions.
Key Features & Benefits
Full Pharmacopoeial Compliance
Each batch of this product gets tested against the latest USP and EP pharmacopoeial standards. Nothing ships without a full official Certificate of Analysis (CoA). That document confirms identity, purity and a low endotoxin level. It also helps firms get through pharmaceutical production checks and regulatory audits.
Very Low Moisture for Sensitive Formulations
Moisture sits under 0.5% in our anhydrous grade. Crystal water interference is gone. That helps drug formulas sensitive to water. Shelf life for the finished medicine gets longer too. Sterile pharma production systems are where this plays out. There, exact ingredient dosing and steady batch consistency keep every batch alike.
Stable & Reliable Buffering Performance
A special acetate ion buffer system goes into parenteral solutions and intravenous preparations. The pH level holds steady between 4.5 and 5.5. Breakdown from pH swings cannot reach the active pharmaceutical ingredients. That keeps pharmacological efficacy steady. Clinical medicine turns safer because of it.
Adapts to Many Industries & Labs
Drug production is not the only spot where this material shows up. Labs that do biochemical work use it as well, mostly to prepare reagents. Makers of diagnostic kits count on it too. Run after run, the output stays consistent. That helps buyers with R&D verification and with validating standard production runs.
Technical Specifications
Parameter | USP / EP Standard | SHANXI ZHAOYI Specification |
|---|---|---|
Assay (CH₃COONa) | ≥99.0% | 99.5%–100.5% |
Moisture (Loss on Drying) | ≤1.0% | ≤0.5% |
pH (5% aqueous solution) | 7.5–9.2 | 7.8–8.8 |
Heavy Metals (as Pb) | ≤0.002% | ≤0.001% |
Chloride (Cl) | ≤0.01% | ≤0.005% |
Sulfate (SO₄) | ≤0.01% | ≤0.007% |
Iron (Fe) | ≤0.001% | ≤0.0003% |
Arsenic (As) | ≤0.0001% | ≤0.00005% |
Particle Size | White Crystalline Powder | 80–120 mesh |
How It Works
USP / EP Grade Sodium Acetate Anhydrous breaks down fast in solutions made with water. Out of it come sodium ions and acetate ions, both stable. Put acetic acid in the mix, and those acetate ions complete a conjugate acid-base buffer system. Any sudden pH jump in the liquid gets taken in and balanced out. Over the long term, pH stays where it should.
With it, dialysis gets safer and steadier. Acidic metabolic substances in the body are neutralized by it, so no bicarbonate-based carbon dioxide builds up. The finished medicine also keeps far longer. Active parts that react to pH, proteins and polypeptides for example, do not break down. Even through high-temperature sterilization of injectable drugs, that protection holds.
Aseptic drug production needs tight temperature control. The anhydrous grade fits that need. It dissolves fast and releases no heat as it dissolves. That's why it works so well in strict sterile processing.
Applications
Pharmaceutical Excipients
It can replace bicarbonate materials. Concentrated dialysis solutions depend on it. Peritoneal dialysis fluids and intravenous mixed preparations do too. Adding it keeps the physiological pH of pharmaceutical solutions steady. No gas forms along the way, so the drug stays safe to use.
Injectable Solutions
It keeps antibiotics, vitamins, and electrolyte supplements effective during autoclaving and high-temperature sterilization. Its buffering action works well and limits API hydrolysis at high heat. That extends the shelf life of finished injectable drugs to 24–36 months.
Biochemical Reagents
People often use it to prepare molecular biology buffer solutions, TAE and TBE among them. Those buffers carry DNA and RNA electrophoresis experiments. Ionic strength stays stable, and one batch matches the next. Research institutions get separation results that repeat and stay accurate.
Diagnostic Kits
It acts as a high-stability pH stabilizer in ELISA detection kits and PCR reaction systems. It effectively reduces detection background noise caused by pH drift, significantly improving the sensitivity and accuracy of diagnostic detection results.
USP / EP Grade Sodium Acetate Anhydrous vs Other Products
Feature | SHANXI ZHAOYI USP/EP | Industrial Grade | Food Grade |
|---|---|---|---|
Purity | 99.5%–100.5% | 58%–62% (Trihydrate) | 99.0% min |
Heavy Metals | ≤0.001% | ≤0.005% | ≤0.0005% |
Endotoxin Testing | Compliant per USP <85> | Not tested | Not required |
CoA Documentation | Full pharmacopoeial data | Basic analysis | Food-grade only |
Packaging | Fiber drum with PE liner | Woven bag | Food-grade PE bag |
Shelf Life | 36 months | 12 months | 24 months |
Certifications & Compliance
Our production system has passed ISO 9001:2015 quality management, ISO 14001:2015 environmental management, and OHSAS 18001 occupational health and safety management system certifications. Every step can be controlled, and production follows set standards. KOSHER and HALAL certificates cover all products too. These are the access rules for major global markets.
Each batch of products is verified by authoritative SGS third-party testing, fully complying with ICH Q7 pharmaceutical GMP specification requirements. We can provide complete regulatory support documents including Drug Master Files (DMF) to assist customers with FDA market filing and compliance audits.
Packaging Options
Standard Pharmaceutical Packaging
The product is packed in 25kg pharmaceutical-grade fiber drums. Inside each drum is a double-layer PE liner. A heat seal closes the liner. Moisture and pollutants stay out. Purity remains stable over long-distance transport and storage.
Custom Alternative Packaging
Multi-layer kraft paper bags with PE inner lining are available for conventional non-sterile production scenarios. We also support personalized packaging customization according to customers’ production specifications and equipment requirements.
Complete Traceability Labeling
All packaging containers are clearly marked with batch number, production date, expiry date and standard storage guidelines, fully compliant with 21 CFR Part 211 regulatory requirements to realize full product traceability.
Manufacturing Process
We select high-purity acetic acid and sodium carbonate raw materials for constant-temperature neutralization reaction in precision-controlled reactors. The reaction solution undergoes 5μm and 1μm multi-stage precision filtration to completely remove particulate impurities and residual contaminants.
Subsequent vacuum crystallization is completed at 60–80°C, matched with professional centrifugal separation and Class D clean room hot air drying process to completely remove crystal water. The final milling and sieving process ensures uniform product particle size distribution and stable physical properties.
We implement real-time in-process monitoring of key indicators such as solution pH, conductivity and optical rotation. All finished products will pass 6-month accelerated stability testing (40°C/75% RH) before factory delivery to ensure long-term stable product performance.
Why Choose Us
36 Years of Professional USP / EP Grade Sodium Acetate Anhydrous Manufacturing Experience
Since 1988, we have been focusing on the iterative upgrading and standardized production of acetate products, accumulating rich pharmaceutical-grade production experience. The stable annual output of 150,000 tons fully guarantees continuous and sufficient supply for customers’ large-scale and long-term production orders.
Mature Global Export System
Buyers in 47 countries and regions take our products. Europe, America, Asia and other markets all receive shipments. Trial orders in small batches? We take those too. So do bulk purchases in large volumes. Standards stay the same, and delivery cycles stay steady.
Pharma Technical Help From Our Own Team
Our technical team can read pharmacopoeia standards and explain them. They also bring real experience with formula application. Formulation optimization guidance comes free of charge. So does sorting out regulatory documents. Customers use both to cut their R&D cycles. Compliance problems get solved along the way.
Green & Sustainable Production
We adopt zero-liquid-discharge production technology, with 95% of process water recycled and reused. Choosing our products means supporting environmentally friendly green pharmaceutical manufacturing and meeting the sustainable development requirements of global brand procurement.
FAQ
Q: What is the most basic difference between anhydrous sodium acetate and trihydrate sodium acetate?
A: A1: Anhydrous sodium acetate holds no water in its structure. The molecular weight comes to 82.03 g/mol. With the trihydrate form, three water molecules sit in the crystal. That pushes the molecular weight to 136.08 g/mol. When you do real formulation work, the anhydrous type takes only about 60% of the trihydrate amount to get the same acetate result. So the formula dose has to be adjusted right. Skip that step and you add too much.
Q: Does this USP/EP grade work for sterile injectable production?
A: A2: Yes, it is fully applicable to sterile injectable preparation. Combined with 0.22μm sterile filtration and standard autoclaving process, our products meet USP <797> sterile preparation specifications, supporting customers’ high-standard aseptic pharmaceutical production.
Q: What storage conditions do unopened products need?
A: A3: Store the goods at a constant 15 to 25°C. Keep humidity under 60%. Seal the containers well. After you open one, use what is inside within 48 hours. If that is not possible, add a desiccant and seal it again. Moisture stays out, so performance holds up.
Q: Can this product be used to make veterinary medicines?
A: A4: Yes. Our products follow mainstream pharmacopoeia standards for veterinary drug production. The EU 2001/82/EC directive requirements are met as well. For your sales market, check the local targeted regulatory standards that apply.
Q: Can European buyers get CEP certification from you?
A: A5: Every batch we ship comes with a full CoA. Need a CEP certificate issued by EDQM instead? Our regulatory team handles the docking and the processing. That is how you meet the access rules for the European market.
Request a Quote
Send your full application requirements for USP / EP Grade Sodium Acetate Anhydrous tosxzy@sxzhaoyi.com.
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