Antibiotic Sodium Acetate Trihydrate

Antibiotic Sodium Acetate Trihydrate for Pharmaceutical Manufacturing | Pharmaceutical-Grade Purity & Stable Supply

Antibiotic Sodium Acetate Trihydrate (CAS No. 6131-90-4) is a critical pharmaceutical intermediate widely used in antibiotic synthesis, pH regulation, and hemodialysis formulations. Produced by Shanxi Zhaoyi Chemical Co., Ltd. — Founded in 1988, the firm has more than 30 years expertise in the acetate sector. >99% pure, chloride 0.005%; heavy metals 0.0005%. Our 27,000 m² structure can accommodate up to 150,000 tonnes of products per year. We promise constant batch quality, variable order quantities and fast shipment within 5–7 working days. All the exports have ISO 9001, ISO 14001 and ISO 45001 permits.

Technical Specifications

What Is Pharmaceutical Grade Sodium Acetate Trihydrate?

Sodium acetate trihydrate (CH₀COONa·3H₂O) This is the crystalline form of sodium acetate with a molecular weight of 136.08. When you combine it with water or alcohol it dissolves quickly. Specific gravity is 1.45. It melts at 58°C.

When pharmaceutical grade sodium acetate trihydrate is made, there are a lot more rules about the manufacturing environment, the impurity profile, and the control of bioburden that must be followed. Because of this, it can be used as a bridge between sodium acetate antibiotics and clean preparation processes where endotoxin levels or trace metal poisoning could directly affect patient safety.

Key Product Characteristics

High purity for sensitive synthesis environments. Purity ≥99% closely regulated impurities - chloride ≤0.005%, heavy metals ≤0.0005% - to fulfill the high needs of antibiotic manufacture. The presence of trace metals such as iron (Fe), lead (Pb) and arsenic (As) has to be checked since even at low quantities they accelerate the destruction of the beta-lactam ring and put your antibiotic product at risk.

Buffering of pH. The production of antibiotics is very sensitive to pH fluctuations. This product may provide dependable buffering capacity to assist you maintain steady reaction conditions throughout the manufacturing operations of penicillin, cephalosporin, macrolide and quinolone.

A sturdy construction and the proper amount of wetness.The trihydrate form contains the water that allows crystallisation in a stable crystal lattice. LOD testing verified this stability, with water content ranging from 39.0% to 40.5%. This stability also prevents the antibiotic granules from leaking water when not wanted, a typical cause of vial caking and failure of the formulation.

Formulated to work with antibiotics.The product is designed to work as a pH regulator, acid-binding agent, catalyst auxiliary, and buffer in the process of making antibiotics. It has a high reaction activity and is compatible with the process.

Quality Control & Testing

Quality control for production of sodium acetate trihydrate that is in line with USP standards goes far beyond simple checks for purity. Every batch goes through a structured testing protocol that was made for the needs of pharmaceutical manufacturing.

Bacterial Endotoxin Test (LAL Test): This is the most important safety factor for both injectable and parenteral uses. To keep patients from having pyrogenic reactions, materials must meet strict endotoxin limits, which are usually less than 2.5 EU/g.

Potassium Permanganate Reducing Substances Test: This makes sure that there are no oxidisable impurities that might combine with active pharmaceutical ingredients (APIs) that are sensitive. For antibiotic production to work, this needs to be a clean pass.

Trace Metal Analysis (ICP-MS): The amounts of iron, lead, and arsenic are carefully watched. It was already said that trace metals can break down beta-lactam antibiotics, so they need to be kept well below the limits allowed by the pharmaceutical industry.

Total Aerobic Microbial Count (TAMC) and Total Combined Yeasts/Molds Count (TYMC) are measured in a way that is in line with good manufacturing practice (GMP) to make sure they are safe for use in clean pharmaceutical environments.

There are COA, MSDS, and other safety papers for all of our goods. Testing by a third party is fine and encouraged.

Situations for Using

This item is a significant sodium acetate antibiotic intermediate used in a lot of different antibiotic classes and preparation types.

Antibiotic synthesis: pH regulator, acid binder and buffer in the making of penicillins, cephalosporins, macrolides and quinolones. It helps keep reaction systems stable during multi-step synthesis because it acts as a buffer.

Injectable and sterile formulations: Its controlled endotoxin profile makes it suitable for use in parenteral preparations where pyrogen-free materials are required.

Hemodialysis concentrates: Widely used as a source of acetate ion in hemodialysis fluids. The liver changes acetate ions into bicarbonate, which protects the body from metabolic acidity. The endotoxin criteria for antibiotic grade are a lot like the criteria for haemodialysis grade.

Preparation of reagent and buffer solutions. The regular pH behavior and good solubility provide it a dependable component in pharmaceutical buffer systems and laboratory scale manufacture of reagents.

Antibiotic Sodium Acetate Trihydrate vs Other Products

Certifications & Compliance

Shanxi Zhaoyi Chemical Co., Ltd. Antibiotic Sodium Acetate Trihydrate operates under a multi-standard quality management framework to support pharmaceutical supply chain requirements.

• ISO 9001 – Quality Management System Certification
• ISO 14001 – Environmental Management System Certification
• ISO 45001 – Occupational Health and Safety Management System Certification

Kosher Certification

Halal Certification (applicable product lines)

On-site factory audits by domestic and international customers are fully supported. Multilingual COA, MSDS, and conformity documents are available upon request to assist with your regulatory filings.

Storage & Handling

Keep in a place that is dry, cool, and has good air flow. Keep it somewhere cool and dry. Be careful when unloading so that you don't damage the packing. Stay away from strong acids, strong oxidisers, and other dangerous substances.

Recommended storage humidity: RH <60% Keep in airtight containers (ideally double PE lined) to stop efflorescence (water loss) and deliquescence, which could change how the powder flows and how accurately it is mixed.

FAQ

Q: What is the difference between antibiotic grade and technical grade sodium acetate trihydrate?

A. The antibiotic grade is produced under GMP conditions and controlled for endotoxins, trace metals and reducing chemicals according to the criteria for pharmaceutical injections. Technical grade cannot be used in the manufacture of parenterals or antibiotics.

Q: How does this product help prevent caking in antibiotic vials?

A: High-quality pharmaceutical-grade sodium acetate trihydrate has a stable crystal structure that keeps its water of crystallisation when stored properly (RH <60%). This keeps powder from moving around in drug bottles and stops moisture from moving.

Q: Can this product be used in hemodialysis formulations?

A: Yes. It is often used in haemodialysis concentrates to add acetate ions, which are then broken down into bicarbonate. It needs to be able to meet endotoxin limits for haemodialysis, which are very similar to antibiotic grade requirements.

Q: How long does it last, and how should it be kept?

A: If you keep it in a cold, dry place away from strong acids and oxidisers, it will last for two to three years.

Q: Can I get samples before I place a big order?

A: Yes. You can also ask for free small-batch samples to see how well the product works in your specific manufacturing or preparation process before you buy the whole thing.

Q: What after-sales support is available?

A：Technical inquiries receive a response within 24 hours. Complaints are addressed within 3 working days. If the product does not meet your antibiotic production requirements, returns and exchanges are accepted unconditionally. Stock is prepared in advance based on your production schedule to prevent supply disruptions.

Contact Us

Ready to source reliable Antibiotic Sodium Acetate Trihydrate for your pharmaceutical operations? Contact our team at sxzy@sxzhaoyi.com  — we respond within 2 hours.