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Ammonium Sulfate (Pharmacopoeia Grade) – USP/BP/EP/ChP Standard Excipient for Pharmaceutical & Biopharma Industry
Published for: Pharmaceutical Factories, Biopharmaceutical Enterprises, Vaccine & Preparation Manufacturers
Pharmacopoeia Grade Ammonium Sulfate is a high-standard pharmaceutical auxiliary material that fully complies with global pharmacopoeia specifications including USP, BP, EP, and ChP. Produced under GMP-compliant production environments, this product features ultra-low impurities, strict microbial control, and zero harmful residues. It is an indispensable key material in pharmaceutical preparation, biopharmaceutical processing, vaccine production, and biological purification, meeting the highest safety and quality requirements of the pharmaceutical industry.
1.Key Product Specifications
Compliance Standards: USP, BP, EP, ChP Pharmacopoeia Grade
Chemical Formula: (NH₄)₂SO₄
CAS Number: 7783-20-2
Purity: 99.0%–100.5%
Residue on Ignition: ≤0.005%
Microbial Limit: Total aerobic bacteria ≤1000 cfu/g, no pathogenic bacteria
pH Value (5% Solution): 5.0–6.0, mild and non-irritating
Quality Guarantee: Each batch is accompanied by a complete COA and batch traceability report
2. Core Advantages
Pharmacopoeia-grade ammonium sulfate adopts pharmaceutical-grade purification and sterile processing technology, with far stricter impurity, microbial, and heavy metal control than reagent and food grades. It has stable chemical properties, no irritation, no drug incompatibility reaction, and will not affect the efficacy and safety of pharmaceutical preparations. The product achieves full batch traceability, standardized production and testing, fully meeting the GMP production requirements of pharmaceutical and biopharmaceutical enterprises, and ensuring the safety, stability, and compliance of finished drugs and biological products.
3. Main Applications
Pharmaceutical Excipient: Used as a stabilizer and regulator in pharmaceutical preparations to adjust solution osmotic pressure and maintain drug system stability.
Biological Purification: Widely used for salting-out, precipitation, and purification of biological products such as proteins, enzymes, and antibodies in biopharmaceutical processing.
Vaccine & Biological Reagent Production: Serves as a nutrient and stabilizer in vaccine and biological reagent preparation to ensure the activity and stability of biological ingredients.
Laboratory Pharmaceutical Research: Applied in new drug development, pharmaceutical component analysis, and biological sample processing for pharmaceutical research institutions.
4. Storage & Notes
Store in a sterile, constant-temperature, dry pharmaceutical-grade storage room, isolated from pollutants, corrosives, and incompatible chemical substances. Keep sealed and moisture-proof, avoid direct sunlight and high temperature. Operate in a dust-free and sterile environment during use to prevent microbial contamination. Strictly implement batch management to ensure product traceability.
