Injection Sodium Acetate Trihydrate

Injection Sodium Acetate Trihydrate for Pharmaceutical Use — High-Purity Buffer Solution for IV & Dialysis Formulations

Injection Sodium Acetate Trihydrate (CAS No. 6131-90-4) is a pharmaceutical-grade excipient widely used in parenteral formulations, dialysis solutions, and biopharmaceutical manufacturing. Produced by Shanxi Zhaoyi Chemical Co., Ltd. The firm was created in 1988 and has over 30 years expertise in acetate chemistry, enough to meet the rigorous demands for injectable-grade applications. It has a purity test of 99.0%-101.0% (dry basis), pH 7.5-9.0 (5% soln) and strict elemental impurity controls compliance with ICH Q3D. Formulators may rely on the same steady buffering performance and sodium ion supply (~17 mEq/g) as they are accustomed to.

Technical Specifications

What Is Injection Sodium Acetate Trihydrate?

Sodium acetate trihydrate (CH₃COONa·3H₂O) is the trihydrate crystalline form of sodium acetate. It has a melting point of 58 °C. Molecular weight is 136.08 g/mol. The pharmaceutical grade is colourless, clear crystals or white granular crystalline powder. It is extremely soluble, 1g dissolves in a mere 0.8mL of water which makes it easy to include into liquid compositions.

It is a sodium acetate trihydrate excipient USP grade designed and tested to the United States Pharmacopoeia (USP), European Pharmacopoeia (EP) and Japanese Pharmacopoeia (JP). It is a pH buffer and electrolyte provider and it is very useful in the making of injectable medications.

Key Product Characteristics

This grade has particular qualities which are of value, especially to injectable medications.

With very few impurities of excellent purity. Assay generally 99.0%-101.0%, heavy metals at sub ppm level. Lead, arsenic and aluminium have been strictly limited to protect patient safety, especially with aluminium accumulation being a neurological threat in hemodialysis.

Buffering performance consistency The buffering capacity of a 5% solution in the pH range 7.5–9.0 is batch to batch steady. This stability is very important for the large volume injection production, for which the sodium acetate trihydrate EP manufacturer level controls need be maintained over the complete manufacturing cycle.

Effloresces in warm air. Very soluble. The crystals may effloresce under hot conditions, however upon production the chemical quickly dissolves and combines homogeneously with IV fluids, dialysis concentrates and TPN admixtures.

Application Areas

Hemodialysis and Peritoneal Dialysis Solutions

This is one of its most significant uses. Sodium acetate for injection buffer usage buffers pH in dialysis acid concentrates and avoids precipitation of calcium and magnesium salts, a frequent problem in bicarbonate-only circuits. Patient safety is directly supported by proper buffering during renal replacement treatment.

This is particularly the case with the stringent aluminium restriction (< 0.2 µg/g). Elemental impurity control is a non-negotiable quality factor for procurement teams purchasing this material, since trace aluminium exposure is very sensitive for dialysis patients.

Large-Volume Injectables (LVI)

In large-volume injection production — including glucose injection and sodium chloride injection — Injection Sodium Acetate Trihydrate acts as both a pH regulator and an electrolyte supplement. It adjusts the formulation pH to 5.0–7.0, closely matching physiological pH, which reduces vascular irritation and improves patient tolerability. It also stabilizes pH during storage, preventing API degradation and extending product shelf life.

TPN (Total Parenteral Nutrition) and IV Mixtures

In patients who cannot take oral nourishment, TPN solutions must be carefully adjusted. Sodium acetate supplies the required sodium for fluid balance and acetate as a metabolizable anion for acid-base control. It is especially effective in the newborn and ICU context when chloride limitation is necessary to prevent hyperchloremic acidosis.

Biopharmaceutical Formulation & pH Control

This sodium acetate trihydrate USP grade buffer is a crucial ingredient for the purification and formulation of biologics and peptide injectables. The ultra-low trace metal concentration guaranties no catalytic impurities are introduced which may destabilise sensitive active pharmaceutical ingredients (APIs).

Injection Sodium Acetate Trihydrate vs Other Products

Quality Control and Documentation

Each batch is tested for comprehensive pharmacopeial assay, pH, elemental impurity screening, endotoxin testing and microbiological compliance. Results in Certificates of Analysis (COA) according to USP, EP and JP standards are provided.

Support from third party testing organisations such as SGS. We provide full documentation packages, including MSDS, COA, and conformity declarations, in different languages to assist with regulatory filings in your target market.

Shanxi Zhaoyi Chemical has also established a documented quality system to provide traceability from source material to final despatch in a sodium acetate trihydrate EP manufacturer level production environment.

Certifications & Compliance

Shanxi Zhaoyi Chemical Co., Ltd. operates under a multi-standard quality management framework:

· ISO 9001 — Quality Management System

· ISO 14001 — Environmental Management System

· ISO 45001 — Occupational Health and Safety Management System

· Kosher Certification

· Halal Certification (applicable food and pharma grades)

The company supports on-site factory audits by domestic and international customers. This level of transparency is important for pharmaceutical procurement teams that need to qualify suppliers under GMP-adjacent or regulated supply chain frameworks.

Packaging and Storage

· Packaging: Pharmaceutical-grade sealed packaging (aluminum-plastic composite bags or sterile plastic barrels); moisture-proof, contamination-resistant, with injection excipient-specific labeling

· Standard pack sizes: 25 kg plastic woven bag or 1,000 kg ton bag

· Storage conditions: Clean, cool, dry sterile warehouse; relative humidity ≤ 60%

· Shelf life: 24 months (unopened); re-inspection required if expired

· After opening: Seal immediately and use within 12 hours

· Handling: Avoid collision and compression during transport to prevent packaging damage

FAQ

Q: This product complies with which pharmacopoeia standards?

A: This product conforms with USP, EP and JP monographs. Sodium acetate trihydrate is a USP grade excipient that passes all purity, pH and elemental impurity standards as stipulated in each pharmacopoeia, making it appropriate for submission to regulators throughout North America, Europe and Asia.

Q: Why is elemental impurity control so critical for this grade?

A: Trace metals such as aluminium, lead and arsenic in injectable products, particularly hemodialysis solutions, may build in patients over time and cause considerable injury. This product regulates aluminium to < 0.2 µg/g and is within the safety margins necessary in the clinic according to ICH Q3D recommendations.

Q: What is the role of sodium acetate as a sodium acetate for injection buffer?

A: It buffers acidic or basic changes in the formulation, providing a constant pH environment (7.5-9.0 in 5% solution). This buffering effect inhibits pH drift during storage, improves medication stability and minimises vascular irritation when the solution is delivered to the patient.

Q: COA and third party test reports do you have?

A: Yes. We have complete batch paperwork including COA, MSDS and Declarations of Conformity. Third party testing may be facilitated with SGS and other recognised labs on request.

Q: What is the minimum order quantity and lead time?

A: We generally aim to fulfilll standard orders within 5-7 business days. If the item is in stock, we may ship it within 24 hours. Get in touch with our staff to verify the availability and MOQ for your unique volume needs.

Q: Is there support for OEM packaging and multi-language documentation?

A: Yeah. We provide custom package types, OEM labelling and multilingual regulatory documentation (MSDS, COA, compliance certifications) to match your local market needs.

Contact Us

Ready to source Injection Sodium Acetate Trihydrate for your pharmaceutical formulations? Contact us at sxzy@sxzhaoyi.com — our technical team responds within 2 hours.