Pharmaceutical Grade Potassium Acetate Raw Material
CAS NO.: 127-08-2
Molecular Formula: CH₃COOK
Molecular Weight: 98.14 g/mol
Grade: Pharmaceutical Raw Material Grade
Character: White crystalline powder with high purity, good water solubility, stable composition, and controlled levels of relevant impurities.
Quality Standard: Manufactured and tested according to the agreed pharmaceutical raw-material specification. Compliance with a particular pharmacopoeial standard should be confirmed using the current certificate of analysis and applicable monograph.
Usage: Used as a raw material in pharmaceutical formulations, electrolyte preparations, pH buffers, biochemical products, laboratory reagents, pharmaceutical intermediates, and other regulated chemical preparations.
Package: 25 kg pharmaceutical-grade fiber drum or paper bag with a double polyethylene inner liner. Customized clean packaging is available.
Storage: Store in a tightly closed original package in a clean, dry, cool, and well-ventilated warehouse. Protect from moisture, contamination, strong acids, oxidizing agents, and toxic substances.
- Product Description
Pharmaceutical Grade Potassium Acetate Raw Material - High Purity Chemical Excipient for Drug Formulation Excellence
SHANXI ZHAOYI CHEMICAL CO., LTD. produces acetates. Back in 1988 our production started. That leaves us with over 35 years of it. The plant covers 27,000 ㎡ and runs a standardized setup. Each year we turn out 150,000 tons. One item from that line is Pharmaceutical Grade Potassium Acetate Raw Material. Tight pharmacopoeia standards are what it meets. As a pharmaceutical excipient it clears the tough component rules set for formulation production. Purity lands at ≥99%. Chloride stays very low, at ≤0.005%. Heavy metals come in at ≤0.0005%. The powder is white and crystalline, with an even look. It dissolves well in water and holds up through sterilization. Active pharmaceutical components keep their activity that way. Quality also stays steady during medication production and storage.
Key Features & Benefits
This product targets two problems that show up often in medication production. Formulation instability is one of them. The other one is interference from impurities. Strict limits on excipient purity and stability are the norm for the pharmaceutical manufacturers it was built for.
Ultrahigh Purity & Low Impurity: Purity in the refined formula runs high. Quality swings caused by excipient impurities do not happen. Interference from trace impurities drops as well. It suits delicate, high-precision pharmaceutical goods.
Stable pH Buffering Performance: The active ingredients stay intact here. Setting the pH is precise. The buffer keeps working over a long period. While production runs, pH values hold steady. Processing and long-term storage don't shift them either.
Excellent Dissolution & Sterilization Resistance: In water, the product dissolves fast and leaves no residue. Nothing solid stays behind, so drug solutions remain pure. High-heat sterilization doesn't change its chemical profile. Potency holds, and it won't degrade.
Consistent Batch Stability: Every stage falls under tight quality control. Content variation from batch to batch stays within ±0.5%. Pharma production then becomes fully repeatable. A clear boost in bioavailability comes with it. The end product also lasts longer on the shelf.
Technical Specifications
Parameter | Specification |
|---|---|
CAS Number | 127-08-2 |
Molecular Formula | CH₃COOK |
Molecular Weight | 98.14 g/mol |
Appearance | White crystalline powder |
Purity | ≥99.0% |
Chloride (Cl⁻) | ≤0.005% |
Heavy Metals (as Pb) | ≤0.0005% |
Water Content | ≤1.0% |
pH Value (5% solution) | 8.0-9.5 |
Solubility | Highly soluble in water |
How It Works
As a multifunctional pharmaceutical excipient, Pharmaceutical Grade Potassium Acetate Raw Material stabilizes drug formulations through multiple professional chemical mechanisms, widely applicable to various pharmaceutical preparation scenarios.
Across the normal pH range of the body, acetate ions keep their buffering power. That is what makes the compound handy as a pH buffer. Acid and alkaline levels in a drug solution stay pinned where they should be. pH can shift while a product is made or stored. The active ingredient then breaks apart. Quality of the formulation drops as a result. Both of these problems are blocked by this buffer.
Potassium appears in the formula as an electrolyte component that keeps the mix balanced. It goes into therapeutic preparations so the body's electrolyte balance can be adjusted. Purity counts here as well. Catalytic impurities get wiped out by an ultra-high grade. That grade also halts the molecular degradation reactions drugs can go through. The finished pharmaceutical products come out more stable and safer, and the body absorbs them more easily.
Applications
Injectable Preparations: A lot of intravenous injection solutions have them in the mix. There they set the pH and hold osmotic pressure level. Injection products stay safe and steady that way while patients get treated.
Oral Solid Dosage Forms: Here the substance works as a buffering excipient. Tablets, capsules, and other oral preparations all carry it. Formulation properties stay stable because of it. The product also keeps for longer on the shelf.
Electrolyte Replacement Therapy: Electrolyte supplement products are another spot where it shows up. A balanced mix of ions is what does the work. That mix lets the body manage its electrolytes and acid-base balance.
Pharmaceutical Intermediate Synthesis: When pharmaceutical intermediates are produced, this material acts as a reaction reagent and a catalyst. Purity levels stay high. That keeps downstream drug production running at a steady output.
Laboratory & Research Use: It works well in biochemical research. Labs also turn to it for analytical testing, and for experiments on drug stability. Standard pH buffer solutions get made with it. Test conditions hold steady when the compound is used.
Pharmaceutical Grade Potassium Acetate Raw Material vs Other Products
Feature | Our Pharmaceutical Grade | Standard Industrial Grade | Food Grade |
|---|---|---|---|
Purity | ≥99.0% | ≥98.0% | ≥99.0% |
Heavy Metals | ≤0.0005% | ≤0.002% | ≤0.001% |
Chloride Control | ≤0.005% | ≤0.01% | ≤0.008% |
Batch Consistency | ±0.5% | ±2.0% | ±1.0% |
Sterilization Stability | Excellent | Not tested | Moderate |
Documentation | Full pharmaceutical COA | Basic COA | Food-grade certificate |
Price Point | Premium | Economy | Mid-range |
Certifications & Compliance
Our plant holds full ISO quality management system certification. Quality checks follow the same standard at every step, from raw material feeding through to delivery of the finished product. We also carry valid KOSHER and HALAL certificates. With them, our products clear the market access rules of most countries and regions around the world.
Everything we produce matches the pharmacopoeia specs that cover pharmaceutical raw materials. Full-index testing is run on each batch. A full official certificate of analysis goes out with the shipment, which means the material meets the production and regulatory standards pharmaceutical makers work to around the world.
Packaging Options
Our packaging is standard and meets pharmaceutical grade. That keeps contamination away from the product. During transport and storage, the raw material holds up well in purity and stability.
Standard Packaging: Fiber drums hold 25kg. They are pharmaceutical grade. Two polyethylene liners sit inside. They block moisture. Moisture and impurities stay out.
Alternative Packaging: We also offer paper bags made to pharma grade. A protective liner goes inside each one. They fit a range of storage and handling needs.
Custom Clean Packaging: Support personalized clean packaging customization for special pharmaceutical production and high-standard experimental scenarios, fully meeting
customer differentiated needs.
Manufacturing Process
We adopt exclusive purification production technology customized for pharmaceutical excipients, selecting high-standard national raw materials as the production base to ensure stable raw material quality from the source.
Purification at our plant moves through several precise stages. Trace impurities get pulled out along the way. That covers heavy metals and chlorides. The material keeps going until it meets pharma-grade index standards. A professional crystallization process then sets the particle size and holds it even. Dissolution performance stays excellent because of that.
Several key control points sit along our production line. That lets us read the numbers as they happen. Before anything ships, every finished batch goes through a full round of tests. Purity and moisture get checked. So do impurities and microbes. Packing then happens in dust-free clean rooms. SGS third-party testing and certification are on offer too, so buyers can confirm the quality is real.
Why Choose Us
Professional Acetate Manufacturing Experience: More than 35 years of our work has gone into this single product. That focus gave us Pharmaceutical Grade Potassium Acetate Raw Material and mature pharmaceutical-grade production technology. Our process formulas are stable as well. Batch quality fluctuations don't happen this way.
Steady Supply at Big Volume: Each year, output hits 150,000 tons. The long-term bulk orders drug companies place are covered by that amount. Their supply line then keeps moving with no gaps.
Skilled Technical Support for Pharma: The people on our technical team know this industry well. Free help with formulation matching comes as standard. So does a check on how well the products work together. Technical indicators sit in the supply contract in plain words. That way nothing stays vague.
Global Export Service System: Mature logistics channels cover Europe, America, Asia and other global markets, with complete export documents. We support large sample delivery for customer product verification, reducing your production trial and error costs.
FAQ
Q: For pharma use, will the potassium acetate you sell pass official pharmacopoeia standards?
A: A1: Yes. Each batch we ship follows the pharmacopoeia rules for pharma raw materials used worldwide. Which pharmacopoeia do you work with? Send us that detail, and the matching COA and compliance paperwork will go out to you.
Q: How long does your product last when it is stored the usual way?
A: A2: Keep the goods inside the sealed pack they arrived in. All you need is a cool, dry place with no dust. Shelf life then reaches 24 to 36 months. The batch certificate of analysis lists the exact valid period.
Q: Can you provide complete regulatory documents for drug registration?
A: A3: Yes, we can. Batch COA, production process files, qualification certifications, and test reports can all be handed over to you. They back up your drug registration and regulatory audit.
Q: How long does the standard lead time run for pharmaceutical grade orders?
A: A4: Standard in-stock orders take 2-3 weeks. Long-term bulk orders are scheduled with priority. For urgent projects, expedited delivery is also available.
Q: How do you get every batch to come out the same?
A: A5: We screen raw materials with strict checks. Production processes are fully validated. Each batch goes through full-index testing. Effective content fluctuation stays within ±0.5%. This keeps the formulation application effect consistent.
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