Pharma Excipient Sodium Acetate Anhydrous
CAS NO.: 127-09-3
Molecular Formula: CH₃COONa
Molecular Weight: 82.03 g/mol
Character: White crystalline powder with high water solubility and controlled impurity levels. Its aqueous solution is mildly alkaline.
Grade: Pharmaceutical Excipient Grade
Usage: Used as a buffering agent, pH-adjusting agent, electrolyte source, formulation auxiliary, laboratory reagent, and excipient in pharmaceutical preparations. Suitability for a specific medicinal product should be verified according to the applicable regulatory and formulation requirements.
Package: 25 kg fiber drum or paper bag with a clean inner polyethylene liner. Customized pharmaceutical packaging is available.
Storage: Store in a tightly closed original package in a clean, dry, and well-ventilated warehouse. Protect from moisture, contamination, heat, and incompatible chemicals.
- Product Description
Pharma Excipient Sodium Acetate Anhydrous – Premium Buffer Solution for Pharmaceutical Formulations
Since 1988, Shanxi Zhaoyi Chemical Co., Ltd. has turned out standardized acetate. Drug formulation plants in many countries come to us for Pharma Excipient Sodium Acetate Anhydrous. Our processes hold ISO certification. Behind that sits a 27,000 ㎡ standardized plant. Each year it can produce 150,000 tons. Assay lands between 99.0% and 101.0%. Loss on drying stays under 1.0%. Water content that low keeps this anhydrous excipient stable. Formulations that cannot handle moisture get a solid option here.
Exact pH control and low moisture matter to drug makers everywhere. We meet both demands. USP, EP, and JP rules are also satisfied in full. Elemental impurity screening runs on every batch under ICH Q3D criteria. Endotoxin testing is just as tight. Results come in under 2.5 EU/g. Safety stays solid. In pharmaceutical use, performance holds steady.
Key Features & Benefits
Moisture Stability for Drug Formulations
Sodium acetate trihydrate holds a large amount of crystal water. This product we supply holds none. Because its structure is fully anhydrous, moisture levels stay very low. Water that sticks around can set off API hydrolysis and cut drug potency. That risk shows up during production, and again over long shelf storage. This product stops it. With moisture held steady, the finished drug gains stability and a longer shelf life. For moisture-sensitive formulations under tight specs, it performs well.
Buffering That Stays Exact & Dependable
Buffering happens from pH 3.6 to 5.6, and that range is held exactly. Protein-based biologics need this. So do high-precision pharma products, for formulation and for production. Through batch manufacturing, pH stays steady and dependable. Formulation quality does not shift. Batch to batch fluctuation comes in at 0%. One small drawback: the material is hygroscopic. So normal handling has to be sealed.
Good Solubility & Easy Processing
At 20°C, water solubility hits 123 g/100 mL. So the product breaks down fast and even inside water-based drug systems. Nothing settles out. It stays in one phase, and no impurity traces get left behind. The powder is crystalline and fine all the way through, which lets you dose accurately and weigh exactly. It also gets along well with processing. Liquid preparation works. Tablet compression works too. Other common pharma production methods do the same.
Technical Specifications
Parameter | Specification |
|---|---|
CAS Number | 127-09-3 |
Molecular Formula | CH₃COONa |
Molecular Weight | 82.03 g/mol |
Assay (dried basis) | 99.0: 101.0% |
Loss on Drying | ≤1.0% (120°C, 2h) |
pH (5% solution) | 7.5: 9.0 |
Chloride (Cl) | ≤0.003% |
Iron (Fe) | ≤0.0002% |
Heavy Metals (as Pb) | ≤0.0003% |
Arsenic (As) | ≤0.0001% |
Bacterial Endotoxins | <2.5 EU/g |
How It Works
Inside acetate buffer systems, sodium acetate works as the main conjugate base. Put it into a medicinal formulation and it splits apart completely, into sodium ions and acetate ions. The pH then stays in balance.
The system's excess hydrogen ions can be promptly neutralized by the free acetate ions, keeping the pH level within a steady range. Sensitive active pharmaceutical components are successfully shielded from quality degradation brought on by pH variations during storage and clinical use by this dependable buffering effect.
It functions as an effective acidity regulator and a safe electrolyte supplement for parenteral medicinal solutions. The sterility and structural integrity of high-purity sterile pharmaceutical goods are efficiently protected by the anhydrous design, which totally removes bound water contaminants.
Applications
Injectable Pharmaceutical Preparations
Endotoxin levels stay very low in our Pharma Excipient Sodium Acetate Anhydrous. That is why it fits so many kinds of injectable drug production. Intravenous infusion solutions use it. So do medical dialysis fluids and intrathecal preparations. It also passes the strict safety rules set for high-end sterile pharmaceuticals.
Oral Solid Dosage Forms
Inside capsules, pH gets adjusted. Pharmaceutical tablets break apart faster as well. Two ingredients that would react badly get blocked from each other. Oral solid drugs keep working longer. Acidic active substances also stay apart from the auxiliary materials.
Topical & Biologic Formulations
Topical medicines need skin pH adjusted. That keeps drug delivery compatible with human skin. Biologic finished products also last longer on the shelf. Protein structure stays stable in lyophilized preparations. Biologic medications are no different.
Pharma Excipient Sodium Acetate Anhydrous vs Other Products
Feature | Sodium Acetate Anhydrous | Sodium Acetate Trihydrate | Sodium Citrate |
|---|---|---|---|
Water Content | <1% | ~40% | Variable (hydrated) |
Buffering pH Range | 3.6: 5.6 | 3.6: 5.6 | 3.0: 6.2 |
Hygroscopicity | High | Moderate | Low |
Moisture-Sensitive Formulations | Preferred | Not Recommended | Suitable |
Heat Stability | Excellent (>300°C) | Moderate | Good |
Certifications & Compliance
Our production factory has obtained ISO 9001:2015 quality management system certification, implementing full-process standardized quality control for pharmaceutical excipient production. The product meets the unified compliance requirements of USP, European Pharmacopoeia and Japanese Pharmacopoeia, fully adapting to global pharmaceutical market access standards.
Equipped with KOSHER and HALAL certifications, our products can enter special medical and health markets worldwide. We provide complete and official COA (Certificate of Analysis) documents for every shipment to support customers’ quality inspection and customs clearance.
SGS audits our production system as a third party, on a set schedule. Full compliance with ICH Q7 pharmaceutical GMP specifications is what those checks confirm. Raw material traceability covers the whole production chain. Raw material procurement is the starting point. Finished product packaging is the end. Quality stays traceable for every batch.
Packaging Options
Standard Pharmaceutical Packaging Our standard option is the 25kg pharmaceutical fiber drum. Inside each drum there is a double-layer LDPE liner. That liner keeps moisture out, and it stops the product from breaking down. For most pharmaceutical excipients, this basic packaging standard is enough.
Customized Cleanroom Packaging We make packaging to order, in food grade or pharmaceutical grade. That way it matches the cleanroom setup a given customer runs. Every pack carries a tamper-proof seal, and the seal shows if the pack has been opened. A batch label goes on too, with full traceability. That keeps the product safe.
Professional Bulk Logistics Packaging Bulk orders go out on moisture-proof pallets, and desiccant is added to each one. Some transport routes are sensitive to heat and moisture. For those cases we put together low-temperature and moisture-proof logistics plans. That way product quality holds up the whole way through transit.
Manufacturing Process
Raw Material Neutralization Reaction Both the acetic acid and the sodium we buy are pharmaceutical grade and high-purity. A neutralization reaction then takes place, under tight control. Every step of that process has someone watching it. As a result, the reaction finishes completely, and no impurities are left behind.
Controlled Crystallization & Separation Crystallization runs under a constant temperature gradient. Particle size distribution in the product stays even that way. Leftover mother liquor is pulled out fully by our centrifugal separation gear. The crystals come out anhydrous and stay whole through the whole process.
High-Purity Drying & Finishing Drying happens in stages, and the temperature holds at 120°C the entire time. That keeps the loss on drying index below 1.0%. Milling comes next, then sieving. The final product has an even particle size. It also meets the particle size standards that major pharmacopoeias set.
Final Quality Inspection & Packaging Before anything leaves the plant, every finished batch gets checked. Endotoxin detection is one of the Pharma Excipient Sodium Acetate Anhydrous steps. Impurity screening and index testing follow it. Only batches that pass go into the dust-free packaging workshop. Sealing is done there, and that is what keeps the finished goods sterile and free of pollution.
Why Choose Us
With more than 35 years of professional acetate manufacturing experience, we are a reliable upstream supplier for global pharmaceutical excipient manufacturers. The stable annual output of 150,000 tons can fully meet customers' long-term bulk procurement demand and avoid supply chain interruption risks.
We have a professional technical team focusing on pharmaceutical excipient application research, providing personalized product grade customization and packaging optimization services according to customers' formulation characteristics and QA management standards.
Our mature global logistics and after-sales system covers Europe, America, Asia and other regions, supporting fast and safe cross-border delivery. We always adhere to long-term partnership-oriented service concept to create stable value for customers.
FAQ
Q: For drug manufacturing, what is the main difference between anhydrous sodium acetate and the trihydrate form?
A: A1: The biggest gap between the two comes down to water. How each one gets used depends on that. Moisture in the anhydrous grade stays under 1.0%, and it holds no crystal water at all. Moisture-sensitive work fits it well. High-temperature pharmaceutical processing suits it too. Crystal water makes up about 40% of trihydrate. That leaves it out of high-precision drug formulations.
Q: Can this product go into injectable pharmaceutical preparations?
A: A2: Yes. Our pyrogen-free grade fully meets the bacterial endotoxin limit requirements for intravenous and injection preparations. Oral and topical formulations work another way. Only the standard grade fits those. So check what your production calls for, then pick the grade that matches.
Q: How should the product be stored so it does not take in moisture?
A: A3: Keep the product dry, and keep humidity low. Containers have to be sealed tight. Airborne moisture gets blocked by our double-layer LDPE lined drums, which stops the anhydrous product from hydrating and going bad while it sits in storage.
Q: Does this product meet more than one international pharmacopoeia standard?
A: A4: Our multi-compendial grade product simultaneously meets USP, EP and JP specification requirements. Each batch is accompanied by a dedicated COA report to confirm targeted compliance indicators for your inspection.
Q: Is it suitable for protein biologic formulation buffering?
A: A5: Yes, it does. A steady pH window from 3.6 to 5.6 is what it buffers. Most protein actives stay stable in that range. Proteins do not denature, so biologic drugs keep their activity.
Q: Is it possible to customize specifications and packaging?
A: A6: Yes. We support personalized customization of product purity indicators, particle size and pharmaceutical-grade packaging solutions to match different customers’ formulation processes and cleanroom production standards.
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