Gyógyszerészeti minőségű etil-acetát

As a leading pharmaceutical chemical manufacturer based in Binzhou, Shandong, Shandong Aolansu Environmental Technology Co., Ltd. was established in 2020 with a clear mission: to provide the global pharmaceutical industry with the highest purity solvents that meet stringent regulatory requirements. Our pharmaceutical-grade ethyl acetate represents the pinnacle of our production capabilities, engineered specifically for the most demanding pharmaceutical manufacturing environments.

Pharmaceutical Grade Ethyl Acetate is far more than just an industrial solvent—it is a critical component in drug manufacturing that directly impacts product quality, patient safety, and regulatory compliance. Unlike industrial or food-grade variants, our pharmaceutical-grade product undergoes rigorous purification processes and quality control measures to ensure it meets the exacting standards set forth in the United States Pharmacopeia (USP), European Pharmacopoeia (EP), and British Pharmacopoeia (BP).

Why Choose Pharmaceutical Grade?

The distinction between pharmaceutical grade and lower grades of ethyl acetate is not merely a marketing distinction—it is a matter of regulatory compliance, product safety, and manufacturing integrity.

1. Pharmacopeia Compliance

Our Pharmaceutical Grade Ethyl Acetate is manufactured and tested in strict accordance with USP, EP, and BP monographs. Industrial grade products typically lack this level of pharmacopeial adherence, making them unsuitable for regulated pharmaceutical production.

2. Ultra-Low Heavy Metals and Residual Solvents

Our product maintains heavy metal levels at ≤2 ppm and arsenic content at ≤0.5 ppm, thresholds that are significantly stricter than industrial grade. Residual solvents are tightly controlled through our advanced distillation processes.

3. Pyrogen-Free and Microbial Control

Produced in our Class 100,000 clean rooms under GMP conditions, our product undergoes sterile filtration and microbial monitoring throughout the production cycle. This is essential for sterile manufacturing applications.

4. Complete Audit Documentation

We provide complete batch records, Certificates of Analysis (COA), GMP documentation, quality system certifications, and audit trails for every shipment as a responsible China supplier and factory.

Our Manufacturing Advantages

Shandong Aolansu Environmental Technology Co., Ltd. has established itself as a reliable partner for pharmaceutical companies worldwide:

• Established in 2020 with modern infrastructure in Binzhou, Shandong

• Comprehensive GMP pharmaceutical production qualifications

• Dedicated clean room production facilities

• Complete quality management system with full traceability

• End-to-end supply chain services with professional export support

• Manager Jiao provides dedicated foreign trade coordination and support

Key Applications

1. API Extraction and Purification

Excellent solvency for active pharmaceutical ingredient extraction

2. Reaction Solvent in Pharmaceutical Synthesis

Ideal medium for organic synthesis reactions

3. Pharmaceutical Formulation Excipient

Approved processing solvent in dosage forms

4. TCM Active Ingredient Extraction

Solvent of choice for botanical extractions

5. Sterile Pharmaceutical Production

Pyrogen-free grade for sterile manufacturing environments

Technical Specifications 

Q&A

Q1: Does your Pharmaceutical Grade Ethyl Acetate fully comply with USP/EP/BP pharmacopeia standards?

A: Yes, our Pharmaceutical Grade Ethyl Acetate is manufactured and tested in full compliance with current USP, EP, and BP monograph specifications. Every batch is tested against all pharmacopeial requirements before release. We provide comprehensive documentation including Certificates of Analysis (COA) with each shipment, which detail all test results against pharmacopeial standards.

Q2: Do you have GMP certification and can you provide audit documentation?

A: Shandong Aolansu maintains full GMP certification for pharmaceutical excipient manufacturing. We undergo regular GMP audits by both domestic and international third-party auditors. For supplier qualification, we provide complete audit documentation including GMP certificate, quality manual, facility validation reports, and we welcome both on-site and virtual audits of our Binzhou production facility.

Q3: How do you ensure impurity control and what special packaging measures are implemented?

A: Impurity control is achieved through strict supplier auditing, multi-stage distillation purification, and comprehensive batch testing using GC-MS and ICP-MS. Complete traceability is maintained through our ERP system. For pharmaceutical grade packaging, we use sterile HDPE drums with tamper-evident seals, nitrogen blanketing, and dedicated pharmaceutical-grade logistics providers.