Pharmaceutical Sodium Acetate Anhydrous

Pharmaceutical Sodium Acetate Anhydrous — USP-Grade Excipient & Buffer Solution for Pharmaceutical Manufacturing

Pharmaceutical Sodium Acetate Anhydrous (CAS No. 127-09-3, chemical formula CH3COONa) is a high purity white crystalline powder that is utilised in pharmaceutical formulation, injectable manufacture and haemodialysis applications. Shanxi Zhaoyi Chemical Co., Ltd., this excipient is manufactured by a company formed in 1988 with over 30 years of acetate salt production expertise, and is produced to fulfil stringent compendial requirements. Our facility is 27,000 m2 and our annual capacity is 150,000 tonnes. We provide constant purity ≥99%, regulated pH 7.5–9.0 and heavy metals ≤0.0005% batch after batch.

Technical Specifications

What Is Pharmaceutical Sodium Acetate Anhydrous?

Sodium acetate anhydrous is sodium acetate without water. This is quite different from sodium acetate trihydrate which contains around 40% water by weight. The anhydrous version contains <1% free water and is the preferred form for moisture sensitive APIs or when high temperature processing conditions are present .

Its molecular weight is 82.03 g/mol and specific gravity 1.528 and melting point of 324 0 C. It is fairly soluble in water (up to 119 g/100 ml at 0° C) and moderately soluble in ethanol, which makes it suitable for various formulations.

The anhydrous form has a higher concentration of active acetate ions per kilogram than the hydrated form, which means a considerable logistical efficiency and improved reactivity per unit weight in synthesis processes.

Key Product Characteristics

Controlled Impurity Profile, High Purity

≥99% purity, reproducible reaction efficiency, dependable formulation. Each batch is tested for chlorides, sulphates, iron, heavy metals and arsenic to strict pharmaceutical limits.

High Buffering Capacity

The chemical guarantees steady buffering in the slightly alkaline region. pH of a 5% aqueous solution 7.5–9.0. Acetate buffers are particularly effective for protein biologics in the mildly acidic pH range of 3.6 to 5.6 when many proteins are in the most stable conformation.

Benefits of Anhydrous Stability

Heat processing does not liberate bound water from the anhydrous grade as the trihydrate form does. This prevents cake collapse of lyophilised goods and API degradation from exposure to moisture during manufacture.

Highly hygroscopic - treat with caution

The chemical is hygroscopic and hence packaging and storage measures are required. Do not allow the product to absorb moisture and lose its effectiveness. After opening containers, use within 24 hours.

Pharmaceutical Applications

Pharmaceutical sodium acetate anhydrous serves multiple critical functions across drug manufacturing:

pH regulator and buffer

It is used as a bulk forming laxative, as a buffer for injectable solutions, oral liquids and topical preparations. It has a good pH range, which makes it a highly important instrument in maintaining formulation consistency throughout the product shelf life.

Dialysis Solutions.

Sodium acetate anhydrous is an important electrolyte balancing agent in hemodialysis concentrate compositions. Grades for use in dialysis must have tight endotoxin limits, generally <3.9 EU/mg, for patient safety.

Antibiotic & Injection Production

It is an excipient and intermediate in the production of injectable drugs and the synthesis of antibiotics. It supports the reaction pathways of APIs and the buffering of the final product. Pharmaceutical grades usually fail the Bacterial Endotoxin Test (BET) unless processed specifically for pyrogen-free, and injectable grade material must pass BET.

3.2 External Preparations and Drug Intermediates

It is also used in topical formulations and as a chemical intermediary in the manufacture of dye and pharmaceutical reagents, showing wide compatibility in manufacturing conditions.

Pharmaceutical Sodium Acetate Anhydrous vs Other Products

Quality Control & Documentation

As a pharmaceutical sodium acetate anhydrous supplier committed to compendial compliance, Shanxi Zhaoyi Chemical supports your procurement and regulatory documentation needs with a complete quality package:

· Full Certificate of Analysis (COA) provided per batch

· Third-party testing supported (including SGS)

· Multilingual MSDS and conformity documents available

· COA includes full impurity data: Fe, Pb, As, Cl, microbiological counts

· Re-inspection required and supported if material exceeds its 24-month unopened shelf life

All production batches are managed in accordance with our ISO 9001-certified quality management system. We also support customer-led factory audits, both domestic and international.

Certifications & Compliance

Shanxi Zhaoyi Chemical Co., Ltd. maintains the following management system certifications and product-level qualifications:

· ISO 9001 — Quality Management System

· ISO 14001 — Environmental Management System

· ISO 45001 — Occupational Health and Safety Management System

· Kosher Certification

· Halal Certification (applicable product grades)

For customers sourcing sodium acetate anhydrous USP manufacturer-qualified material, we provide full documentation to support your supplier qualification process, including compendial references and quality agreements.

Packaging & Storage

Packaging Options

· 25 kg plastic woven bags (standard)

· 1,000 kg ton bags (bulk orders)

· Pharmaceutical-grade sealed packaging with moisture-proof barrier materials available on request

Storage Requirements

· Store in a clean, cool, dry warehouse with relative humidity ≤60%

· Keep away from heat, moisture, oxidants, and toxic or odorous substances

· Store separately from incompatible materials

· Avoid impact or compression during transport to prevent packaging damage

· Shelf life: 24 months (unopened); re-inspection required before use after expiry

Why Source From Shanxi Zhaoyi Chemical?

When selecting a supplier for long-term procurement, supply dependability and batch uniformity are as important as the price.

Reliability of supply

We can handle order from small trial amounts to full container loads. Our yearly manufacturing capacity is 150,000 tons with maintained safety stock for standard grades. Standard lead times are 5-7 working days, with in stock items available for delivery within 24 hours.

Customisable Flexibility

If your client has special purity standards, packaging requirements, or OEM labelling needs, our team can provide a personalised solution. We normally supply Sodium acetate anhydrous 99% pharma grade, also facilitate cooperative development for higher specification needs, such as low endotoxin or ultra-low impurity grades.

Competitive Pricing

Thanks to optimised logistics and large scale manufacturing, we are able to provide cheap prices without sacrificing quality. We support such trade terms as FOB, CIF, DAP, etc. We also provide flexible payment terms for long-term partners.

Technical Assistance

Our staff offers 24/7 technical consulting, sample testing assistance and application specific help during your procurement and formulation process.

FAQ

Q: What is difference between sodium acetate anhydrous and sodium acetate trihydrate in pharmaceutical formulation?

A: The anhydrous form includes up to 1% free water, whereas the trihydrate contains ~40% water by weight. The anhydrous grade is chosen by formulators in the development of moisture sensitive APIs or in high temperature processing as the release of bound water from the trihydrate might result in cake collapse or degradation of the active ingredient.

Q: Does this grade apply for injection drugs?

A: Yes, but only if the drug meets pyrogen-free or low-endotoxin standards. Injectables: Standard pharmaceutical grades should be confirmed for the BET limits required for intravenous or intrathecal administration before to usage.

Q: Is your product compliant with USP, EP and JP standards?

A: We manufacture material that meets the important pharmacopeial standards. Please ask for batch COA to verify compendial compliance for your market. We do allow for third party verification via firms such as SGS.

Q: How to preserve the product after opening?

A: Because it is hygroscopic, reseal the bottle immediately after use. Store in a cool, dry place, <60% relative humidity. If it is exposed to humidity, it will clump and may fail the Loss on Drying criteria.

Q: Can anhydrous sodium acetate be used in the formulation of protein based biologics?

A: Sure. The acetate anion is physiologically well tolerated and does not denature proteins. It offers robust buffering in the pH 3.6–5.6 range where many proteins are at their most stable and is hence an often used buffer component in the production of biologics.

Q: What is the minimum order quantity and how fast can you deliver?

A: We can do small orders for test and big quantities for purchase. Standard grades in stock may be delivered within 24 hours. Standard production orders are sent within 5-7 business days. Contact us to discuss your unique volume and schedule needs.

Contact Us

Ready to request a Pharmaceutical Sodium Acetate Anhydrous sample or quotation? Email our team at sxzy@sxzhaoyi.com — we respond within 2 hours on business days.