Pharmaceutical Sodium Acetate Trihydrate

Pharmaceutical Sodium Acetate Trihydrate for Pharma & Biotech — Precision-Grade Buffering & Electrolyte Solutions

Pharmaceutical Sodium Acetate Trihydrate (CAS 6131-90-4, CH3COONa·3H2O) is a pharmaceutical grade acetate salt manufactured under strict GMP conditions to meet the USP, EP and BP monograph specifications. Produced by Shanxi Zhaoyi Chemical Co., Ltd. — a producer with over 30 years experience in acetate industry and 150,000 tonnes of annual capacity — The product purity is ≥99.5%, the heavy metals are limited (Pb ≤0.0005%), and the pH of 5% aqueous solution is 7.5–9.0. For delicate parenteral, dialysis and biopharmaceutical applications demanding consistency, safety and regulatory compliance.

Technical Specifications

What Is Pharmaceutical Sodium Acetate Trihydrate?

Pharmaceutical standards are very high for the crystal of sodium acetate trihydrate.Weight in molecules: 136.08The crystal is clear and has no smell. It melts at 58 degrees Celsius and has a specific gravity of 1.45.

Pharmaceutical sodium acetate is manufactured under current good manufacturing principles (cGMP) and tested to pharmacopeial standards.It reduces the levels of chemical pollutants, endotoxins and bacterial spoilage in oral and injectable forms.

It is soluble in water and alcohol hence it is suitable for usage in water-containing goods.pH-sensitive medication has to be buffered.

Key Product Characteristics

The features of this product make it ideally suited for pharmaceutical manufacture, including:

Form: Stable hydrated phase with homogenous, colourless crystals

Solubility: Soluble in water and alcohol, weakly soluble in acetic acid.

Buffer capacity: Maintains pH stability throughout formulation storage cycles

Low impurity profile: Controlled chloride, iron, arsenic and heavy metals content

Biological safety Microbial content (bacteria, fungus) satisfies the standards of medicinal excipients

When procuring from generic chemical suppliers these features jointly solve the variability difficulties that pharmaceutical procurement teams face.

Pharmaceutical Applications

pH Buffering in Injection Production

Injectable formulation pH must be precise for patient safety and medication stability. The physiological pH range of 4.0–9.0 is maintained by sodium acetate trihydrate, a reliable pH regulator.

Sodium chloride injections with the right amount of this chemical protect pH during storage, prevent drug deterioration, and reduce vascular and tissue irritation. Pharmaceutical formulators prefer its batch-to-batch buffering efficiency.

Replacement electrolytes in haemodialysis

It is a significant electrolyte replacement agent in haemodialysis concentrates and IV fluids. It treats metabolic acidosis, which dialysis treats.

Sodium acetate trihydrate USP EP BP grades are the industry standard for these vital healthcare applications due to their low endotoxin requirement and rigorous elemental impurity limits.

Biopharmaceutical buffers

Biotech monoclonal antibodies and protein-based medicines use acetate buffers. Pharmaceutical sodium acetate trihydrate is 99.5% pure and won't affect biological tests or sensitive drugs.

The three-dimensional crystal structure and controlled water content make buffer manufacture repeatable and essential for bioprocessing and QbD manufacturing.

Pharmaceutical Sodium Acetate Trihydrate vs Other Products

Quality Control & Documentation

According to Chinese Pharmacopoeia rules and foreign pharmacopeial monographs, each manufacturing lot for Pharmaceutical Sodium Acetate Trihydrate goes through several steps of quality testing. Assay, pH, elemental impurities, microbiological limits, and physical features are all tested for.

Full documentation packages are available, including:

• Certificate of Analysis (CoA)
• Material Safety Data Sheet (MSDS)
• GMP Compliance Documentation
• Third-party test reports (e.g., SGS)
• Multilingual conformity documents

We provide third-party testing help to clients that need independent verification before regulatory submission or product certification. This level of openness in paperwork is particularly critical for pharmaceutical sodium acetate providers to regulated markets in the EU, US and Asia.

Certifications & Compliance

Shanxi Zhaoyi Chemical Co., Ltd. maintains a comprehensive certification framework to support your supply chain compliance and regulatory requirements:

• ISO 9001 — Quality Management System
• ISO 14001 — Environmental Management System
• ISO 45001 — Occupational Health & Safety Management System

Kosher Certification

Halal Certification (applicable product grades)

GMP-aligned production environment

On-site factory audits by domestic and international customers are welcomed. This transparency supports your supplier qualification and vendor audit processes without delays.

Packaging, Storage & Supply

Packed in 25 kilogram plastic woven bags or 1000 kg tonne bags for export shipping. Custom packaging with OEM labelling and language options available upon request.

Storage: Store in well-ventilated warehouse. Transportation and storage Store in a cool and humid place. Do not abuse the package by dropping, etc. Store away from harmful chemicals.

We keep basic goods as safety stock, so normally they will be available within 5-7 working days and orders for items that are in stock are sent within 24 hours.

FAQ

Q: Does this product meet USP, EP, and BP pharmacopoeial standards?

A：Yes. This product is made in accordance with the criteria of USP EP BP for Sodium Acetate Trihydrate. Each batch is accompanied by full pharmacopeial paperwork and test results.

Q: What purity level does your product offer?

A：Assay ≥99.5% (CH3COONa·3H2O) Impurities closely regulated such as heavy metals ≤0.0005% and arsenic ≤0.0001%, according to pharmaceutical excipient standard.

Q: Please give GMP and third party test report?

A：Yes, we have GMP compliance documents, CoA, MSDS and third party reports (SGS included). Returns/Replacements are unconditionally given in the event the product is not of the agreed pharmaceutical quality.

Q: What is the shelf life and storage conditions for the product?

A：The goods should be kept in a dry and ventilated facility, avoiding heat and moisture. Shelf life details should be confirmed with our technical staff at the time of purchase as circumstances may vary.

Q: What is the lead time for bulk pharmaceutical orders?

A：Standard lead time is approximately 5–7 working days. For in-stock items, delivery can be arranged within 24 hours. Stock can be reserved in advance based on your production schedule.

Q: Is free sampling available before placing a bulk order?

A：Yes. We provide free small batch samples to ensure the product is compatible with your unique formulation prior to a commercial purchase.

Contact Us

Ready to source reliable Pharmaceutical Sodium Acetate Trihydrate for your production needs? Contact us at sxzy@sxzhaoyi.com  — our team responds within 2 hours.​​​​​​​