Pharmaceutical Grade Ethyl Acetate is a GMP-produced solvent meeting USP/EP/BP pharmacopeia standards with ultra-low impurities, ensuring safety for critical pharmaceutical applications. From an experienced China factory, we provide full audit documentation and complete supply chain services. Trusted quality, reliable supply, global reach.
Pharmaceutical Grade Ethyl Acetate manufacturers often evaluate solvents from a different perspective than general chemical buyers. Purity alone is not enough; moisture, non-volatile residues, trace metals, batch-to-batch consistency, documentation, packaging, and supply traceability can all affect process stability and supplier qualification. AOLANSU provides high-purity solvent solutions designed around these procurement and production requirements.
Manufactured by Shandong Aolansu Environmental Technology Co., Ltd., a professional chemical supplier in China, the product is purified and quality-controlled for demanding pharmaceutical processing applications. AOLANSU also holds a Hazardous Chemicals Business License, supporting compliant handling and commercial supply of hazardous chemical products.
Technical Specifications
The following specification profile is designed to help pharmaceutical manufacturers evaluate solvent quality during technical review, supplier qualification, and incoming-material inspection.
Parameter
Pharmaceutical Grade
Industrial Grade
Food Grade
Test Method
Purity (GC)
≥99.9%
≥99.0%
≥99.5%
USP <621> GC
Water Content
≤0.05%
≤0.1%
≤0.08%
USP <921> KF
Heavy Metals
≤2 ppm
≤10 ppm
≤5 ppm
USP <231>
Arsenic Content
≤0.5 ppm
≤5 ppm
≤2 ppm
USP <211>
Non-Volatile Matter
≤0.005%
≤0.02%
≤0.01%
USP <621>
Acidity
≤0.005%
≤0.01%
≤0.008%
Titration
Color (APHA)
≤10
≤20
≤15
USP <631>
Pharmacopoeia Compliance
USP / EP / BP
None
Food Grade
Pharmacopoeia Standard
GMP Certification
Available
Not Available
Not Available
Quality Audit
Microbial Limit
TAMC ≤10² CFU/g
Not Tested
Limited
USP <61> / <62>
Endotoxin
<0.25 EU/ml
Not Tested
Not Tested
LAL Test
Shelf Life
24 Months
12 Months
18 Months
Stability Testing
Packaging Options
25L / 200L Pharmaceutical Grade Drum, IBC Container / ISO Tank
180L Drum / IBC Tank
180L Drum / IBC Tank
Pharmaceutical Packaging
Specific specification, pharmacopoeial status, certification, and documentation should be confirmed for the applicable batch and customer application before procurement.
Designed Around Pharmaceutical Procurement Requirements
For pharmaceutical buyers, the key question is often not simply whether a solvent dissolves a particular material, but whether its quality can be controlled throughout the purchasing and manufacturing cycle.
Low Moisture for Process Control
Water content can influence extraction efficiency, reaction conditions, crystallization behavior, and downstream processing. The specified water content of ≤0.05% provides a controlled starting point for processes where moisture needs to be minimized. This is particularly relevant for manufacturers whose production procedures have defined solvent specifications and narrow process tolerances.
Controlled Trace Impurities
Heavy metals, arsenic, acidity, color, and non-volatile matter are included in the quality profile because trace contaminants can become important during pharmaceutical process development and quality assessment. AOLANSU uses purification and testing procedures intended to maintain controlled impurity levels and consistent material characteristics between batches.
Batch Documentation for Supplier Qualification
A pharmaceutical solvent supplier needs to provide more than a drum of material. Buyers may need documentation for incoming inspection, internal quality review, supplier approval, and batch traceability. Depending on the supply arrangement, AOLANSU can provide COA, batch testing records, quality inspection documentation, and traceability information to support customer quality-control procedures.
Application Areas
API Extraction and Purification
Pharmaceutical Grade Ethyl Acetate can be used in liquid-liquid extraction and purification operations during active pharmaceutical ingredient production. Its solvent properties allow manufacturers to separate target compounds from process mixtures while maintaining controlled material quality. For API projects, buyers can evaluate purity, moisture, acidity, residue, and other parameters against their own process specifications before selecting the appropriate grade.
Pharmaceutical Synthesis
In pharmaceutical synthesis, solvent selection can influence reaction conditions, material handling, separation, and subsequent purification. High-purity material with controlled moisture and impurities can provide a more predictable input for established manufacturing procedures. The product is suitable for pharmaceutical companies requiring solvent quality beyond conventional industrial-grade specifications.
Formulation and Process Manufacturing
Some pharmaceutical manufacturing operations require solvents during intermediate processing, preparation, or other controlled production steps. Consistent solvent characteristics can help reduce variability in established manufacturing procedures. The appropriate grade and specification should be selected according to the formulation, process, and applicable regulatory requirements.
Botanical and Natural Ingredient Extraction
Ethyl acetate is also used for extracting selected compounds from botanical materials and other natural sources. Controlled purity is particularly important when the extracted material will subsequently enter pharmaceutical or health-related processing. This application can include natural product and TCM extraction, where solvent selection is evaluated alongside extraction efficiency and downstream purification requirements.
Quality Control from Raw Material to Shipment
AOLANSU approaches pharmaceutical chemical supply through multiple quality-control stages rather than relying solely on finished-product testing. Raw materials are inspected before entering production. During purification and processing, key parameters are monitored to maintain process consistency. Finished material is then tested against defined quality specifications before packaging and shipment.
Batch identification and documentation provide additional traceability for customers managing supplier qualification and incoming material control. This approach is intended to address a practical concern for pharmaceutical procurement teams: whether the same specification can be maintained when the next batch is ordered.
Manufacturer and Supply Capability
Shandong Aolansu Environmental Technology Co., Ltd. was established in 2020 and is located in Binzhou, Shandong, China. The company focuses on pharmaceutical chemicals, high-purity solvents, and related chemical products for domestic and international customers.
AOLANSU provides supply support for pharmaceutical manufacturers, chemical distributors, and industrial buyers that require controlled specifications and export-oriented service. The company also holds a Hazardous Chemicals Business License, providing an important compliance credential for customers conducting supplier assessment and chemical procurement.
Packaging and International Delivery
Different pharmaceutical production volumes require different packaging strategies. Pharmaceutical Grade Ethyl Acetate can be supplied in:
25L pharmaceutical-grade drums
200L pharmaceutical-grade drums
IBC containers
ISO tank solutions for suitable bulk requirements
Packaging and transportation arrangements can be discussed according to order volume, destination, storage conditions, and applicable hazardous-chemical transportation requirements. For recurring procurement, AOLANSU can also coordinate batch documentation and delivery schedules to support customers with ongoing production demand.
Frequently Asked Questions
What should pharmaceutical buyers check before purchasing?
Buyers should normally review purity, water content, non-volatile residue, acidity, trace-metal levels, packaging, shelf life, documentation, and applicable regulatory requirements. The customer's internal specification should remain the final reference for qualification.
How is this grade different from industrial-grade material?
Industrial-grade solvents are generally designed around general processing and manufacturing requirements. Pharmaceutical-grade material typically requires tighter impurity control, stronger batch traceability, more detailed documentation, and specifications aligned with the intended pharmaceutical process.
Can AOLANSU provide a COA for each batch?
Yes. AOLANSU can provide a Certificate of Analysis (COA) and relevant batch quality documentation according to the supply agreement and customer requirements.
Is it available for bulk purchasing?
Yes. Supply can be arranged in drums, IBC containers, or suitable bulk formats. Packaging and delivery can be discussed according to the customer's annual consumption, order quantity, destination, and handling requirements.
Can the specification be customized?
AOLANSU can discuss customer-specific quality requirements, packaging, and documentation. Before an order is placed, buyers should provide their required specification so that technical feasibility and compliance can be confirmed.
Does AOLANSU support overseas pharmaceutical customers?
Yes. Shandong Aolansu Environmental Technology Co., Ltd. supports international chemical supply and can coordinate export packaging, documentation, and logistics according to destination requirements.
Why Choose AOLANSU
For pharmaceutical procurement teams, the value of a solvent supplier is closely connected with quality consistency, documentation, traceability, compliance support, and dependable delivery. AOLANSU combines controlled purification, batch testing, pharmaceutical-oriented packaging, and export supply experience to provide a practical sourcing option for customers using Pharmaceutical Grade Ethyl Acetate in API extraction, synthesis, formulation processing, and natural ingredient extraction.
Before commercial use, customers should verify the applicable specification, regulatory status, documentation, and suitability for their specific pharmaceutical process.
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