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Pharmaceutical Sodium Acetate Anhydrous

Product Name: Pharmaceutical Sodium Acetate Anhydrous
CAS NO.: 127-09-3
Molecular Formula: CH3COONa
Molecular Weight: 82.03
Character: white crystal powder; specific gravity is 1.528 and melting point is 324℃.
Usage: It is a kind of chemical raw material and is widely used in dye, pharmaceutical, chemical reagent fields, sewagement and etc.
Package: 25kg plastic woven bag or 1000kg Ton-bag
Storage: It should be stored in a dry and ventilative warehouse, kept away from heat and moisture during transportation, unloaded with care so as to avoid damage. Furthermore, it must be stored separately from poisonous substances.
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  • Product Description

Pharmaceutical Sodium Acetate Anhydrous - High-Purity Chemical Excellence

Shanxi Zhaoyi Chemical Co., Ltd. delivers premium Pharmaceutical Sodium Acetate Anhydrous backed by over 35 years of manufacturing expertise since 1988. Our product meets strict pharmaceutical-grade standards with ≥99.0% purity and <1% moisture content, sourced from our certified 27,000 m² production facility with 150,000 tons annual capacity.

This white crystalline powder features a molecular weight of 82.03 and superior buffering performance (pH 7.5-9.2). Your formulations benefit from our multi-compendial compliance (ISO, KOSHER, HALAL certified), ensuring consistent quality for moisture-sensitive applications. With a melting point of 324℃ and specific gravity of 1.528, our product provides optimal stability for injectable drugs, biologics, and advanced pharmaceutical preparations across global markets.

Key Features & Benefits

Superior Purity for Critical Applications

You receive pharmaceutical-grade material with ≥99.0% assay content and strictly controlled impurities. Heavy metals stay below 0.002%, while iron content remains under 0.0005%, meeting the most stringent pharmacopeia requirements.

Moisture-Resistant Anhydrous Form

Our anhydrous variant contains less than 0.1% free water, preventing hydration-related degradation in your sensitive formulations. This characteristic makes it ideal when you're working with water-sensitive active pharmaceutical ingredients.

Consistent Buffering Performance

The product maintains stable pH values between 7.5-9.2 in 5% aqueous solutions. Your formulations achieve reliable buffering capacity, ensuring drug stability throughout the product lifecycle.

Multi-Compendial Compliance

We manufacture to meet USP, EP, and JP specifications simultaneously. You gain regulatory flexibility for international market distribution without reformulation concerns.

Enhanced Bioavailability Support

The high-purity acetate ions facilitate precise pH adjustment in your preparations. This precision helps optimize drug absorption rates and therapeutic effectiveness in vivo.

Technical Specifications

Parameter
Specification
Test Method
Content (CH₃COONa)
≥99.0%
Titration
pH Value (5% solution)
7.5-9.2
Potentiometric
Clarity Test
Qualified
Visual inspection
Water Insoluble
≤0.01%
Gravimetric
Chloride (Cl)
≤0.002%
Silver nitrate method
Sulfate (SO₄)
≤0.01%
Barium sulfate method
Phosphate (PO₄)
≤0.001%
Spectrophotometry
Magnesium (Mg)
≤0.002%
ICP-AES
Calcium (Ca)
≤0.05%
ICP-AES
Iron (Fe)
≤0.0005%
ICP-AES
Heavy Metals (as Pb)
≤0.002%
Colorimetric
Loss on Drying
<1.0%
Thermogravimetric

How It Works?

Buffering Mechanism in Pharmaceutical Systems

When you add this compound to aqueous formulations, it dissociates into sodium and acetate ions. The acetate ions function as a weak base, accepting protons from stronger acids present in your solution.

This proton exchange creates a stable pH environment between 3.6-5.6, where many active pharmaceutical ingredients maintain optimal stability. The buffering action prevents pH drift during storage and after administration.

Protein Stabilization in Biologics

Your protein-based drugs benefit from the gentle ionic environment created by acetate buffers. The acetate anion exhibits minimal interaction with protein tertiary structures, preventing denaturation during freeze-thaw cycles and long-term storage.

Excretion and Metabolic Pathway

Once administered, sodium ions distribute throughout extracellular fluid while acetate enters the citric acid cycle. Your patients experience rapid metabolic clearance with no accumulation, making it suitable for repeated dosing schedules.

 
Our Factory
 

30-YEAR ACETATE SPECIALIST | Non-caking, High Purity, Global Supply Chain

our factory
our factory
factory workshop
factory workshop
our laboratory
our laboratory

Applications

Injectable Pharmaceutical Formulations

You can consolidate our pyrogen-free review fabric into IV arrangements, intramuscular infusions, and dialysis liquids. The ultra-low endotoxin levels (<3.9 EU/mg) meet parenteral administration safety requirements.

Buffer Frameworks for Biologics

Monoclonal antibodies, immunizations, and recombinant proteins keep up basic keenness in your acetate-buffered definitions. This application is especially profitable when working with pH-sensitive biologics requiring 4.5-5.5 pH ranges.

Tablet and Capsule Excipient

Your strong measurement shapes pick up stream enhancement and compression characteristics. The anhydrous nature avoids moisture-induced caking amid tableting processes.

Analytical Chemistry Standards

Laboratory applications advantage from the tall immaculateness for planning standard buffer arrangements. You accomplish reproducible explanatory comes about in HPLC versatile stages and spectrophotometric analyses.

Dialysis and Renal Therapy

Hemodialysis concentrate definitions utilize this fabric for electrolyte adjust. The pharmaceutical immaculateness guarantees quiet security amid amplified dialysis sessions.

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Pharmaceutical Sodium Acetate Anhydrous vs Other Products

Feature
Our Pharmaceutical Grade
Standard Industrial Grade
Sodium Acetate Trihydrate
Purity (CH₃COONa)
≥99.0%
95-98%
≥99.0% (but 40% water by weight)
Water Content
<1.0%
2-5%
~39-40%
Heavy Metals (Pb)
≤0.002%
≤0.005%
≤0.002%
Iron Content (Fe)
≤0.0005%
≤0.002%
≤0.001%
Endotoxin Control
<3.9 EU/mg (injectable grade)
Not controlled
<3.9 EU/mg (injectable grade)
Multi-Compendial
USP/EP/JP compliant
No certification
USP/EP/JP compliant
Hygroscopicity
Moderate (requires proper storage)
High
Lower (stable crystal water)
Storage Stability
24 months (sealed)
12 months
36 months
Price Efficiency per Active Ion
Higher concentration per kg
Lower purity reduces value
Lower due to water weight

Certifications & Compliance

Worldwide Quality Standards

Our fabricating office works beneath ISO 9001:2015 quality administration certification. You get steady batch-to-batch execution confirmed through thorough in-process controls.

Religious Dietary Compliance

KOSHER and HALAL certifications empower your item dissemination in religiously attentive markets. These certifications cover our whole generation chain from crude materials to last packaging.

Pharmacopeia Compliance

Each clump experiences testing against Chinese Pharmacopoeia, USP, and EP benchmarks. Your Certificate of Examination affirms multi-regional administrative compliance for disentangled worldwide registration.

Good Fabricating Practices

Production takes after pharmaceutical GMP rules with recorded standard working methods. Our quality affirmation group conducts third-party confirmation through SGS research facilities when you require extra approval.

Certification Certificate
 
Certification Certificate
 
Certification Certificate
 
Certification Certificate
 
Certification Certificate
 
Certification Certificate
 

Packaging Options

Standard Pharmaceutical Packaging

You get 25kg plastic woven packs with twofold LDPE moisture-barrier liners. The internal layer anticipates mugginess presentation amid capacity and taking care of in your facility.

Bulk Supply Configuration

For large-scale fabricating operations, we offer 1000kg ton-bags with fortified lifting circles. These gigantic packs highlight pharmaceutical-grade insides coatings keeping up item keenness amid bulk transfers.

Moisture Security Features

All bundling incorporates desiccant sachets and heat-sealed closures. The pharmaceutical-specific labeling shows bunch numbers, fabricating dates, and dealing with enlightening in different languages.

Custom Bundling Solutions

When your detailing requires specialized amounts, we oblige custom bundling from 10kg to 500kg setups. Contact our specialized group to talk about your particular necessities.

 
Shipment
 
Maritime Transport
Maritime Transport
Air transport
Air transport
Land transportation
Land transportation​

Manufacturing Process

Raw Material Selection and Purification

We start with high-purity glacial acetic acid and pharmaceutical-grade sodium hydroxide. Your product quality begins with rigorously tested feedstock meeting international chemical standards.

Neutralization Reaction Control

The synthesis occurs in jacketed glass-lined reactors with precise temperature monitoring. Controlled addition of sodium hydroxide to acetic acid maintains optimal reaction kinetics while preventing local pH extremes.

Crystallization and Dehydration

Following neutralization, the solution undergoes controlled evaporation to supersaturation. Your Pharmaceutical Sodium Acetate Anhydrous product forms through carefully managed vacuum drying at temperatures preventing decomposition.

Multi-Stage Purification

Recrystallization removes trace impurities including heavy metals and chlorides. This pharmaceutical-grade purification ensures you meet the strict specifications for injectable and oral formulations.

Quality Testing and Release

Each production batch undergoes 18-parameter testing including microbiological screening. You receive products only after our QA department confirms full compliance with all specifications.

 
Packing
 

Packing

Why Choose Us?

Three Decades of Fabricating Excellence

Since 1988, we've refined our acetic acid derivation generation forms. Your orders advantage from organization information gathered over thousands of effective clusters provided to pharmaceutical producers worldwide.

Integrated Generation Capacity

Our 27,000 m² office houses total amalgamation, decontamination, and bundling operations. You encounter shorter lead times and superior supply chain unwavering quality through our vertically coordinates manufacturing.

Global Conveyance Network

We keep up dynamic trade channels to Europe, America, and Asia. Your universal operations pick up coordinations bolster through our set up cargo sending associations and documentation expertise.

Technical Bolster Team

Our 60-person workforce incorporates detailing chemists and administrative pros. You get application direction custom-made to your particular pharmaceutical advancement challenges.

Customer-Centric Philosophy

We prioritize long-term associations over value-based connections. Your victory drives our nonstop enhancement activities in quality frameworks and benefit delivery.

Flexible Arrange Quantities

Whether you require 100kg for clinical trials or 50 tons for commercial generation, we suit your volume prerequisites. This adaptability bolsters your development from advancement through advertise dispatch stages.

Our Customer

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FAQ

Q: What distinguishes your product from trihydrate forms?

A: The anhydrous form contains <1% water versus ~40% in trihydrate. You choose anhydrous when formulating moisture-sensitive drugs or when high-temperature processing would release bound water, causing stability issues.

Q: Can this fabric be utilized in injectable medications?

A: Yes, but you must indicate our 'Pyrogen-Free' review. This variation meets strict Bacterial Endotoxin Test limits required for intravenous organization, which standard pharmaceutical grades may not satisfy.

Q: How ought to we store this fabric to keep up anhydrous state?

A: Store in firmly fixed holders inside cool, dry ranges with relative mugginess ≤60%. Presentation to dampness causes clumping and transformation to hydrated shapes, coming up short Misfortune on Drying specifications.

Q: Does your item comply with numerous pharmacopeias simultaneously?

A: Yes, our multi-compendial review fulfills USP, EP, and JP determinations concurrently. Your Certificate of Examination affirms which compendial guidelines each particular bunch meets.

Q: Is this reasonable for pH alteration in protein-based biologics?

A: Completely. The acetic acid derivation buffer is naturally well-tolerated and gives steady buffering between pH 3.6-5.6 where numerous proteins stay steady without denaturation risks.

Q: What is the normal rack life in unopened packaging?

A: You get 24 months rack life from fabricating date when put away legitimately. We suggest re-inspection some time recently utilize if fabric surpasses this period.

Q: Do you give Certificates of Investigation with shipments?

A: Each clump ships with total COA archiving all determination parameters. You too get Security Information Sheets and administrative back documentation upon request.

Q: What least arrange amounts do you require?

A: We oblige orders from 100kg for inquire about purposes to full holder loads for commercial fabricating. Contact us to talk about your particular volume needs.

Request a Quote

Ready to secure high-purity Pharmaceutical Sodium Acetate Anhydrous for your formulations? Contact our team at sxzy@sxzhaoyi.com to receive technical specifications, pricing, and delivery timelines tailored to your requirements.

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