Pharmaceutical Ethanol 99% – Solvent for API Synthesis & Tablet Formulation
Pharma-grade Ethanol 99% is utilized as a co-solvent, crystallization medium, and coating agent in pharmaceutical manufacturing. Satisfies USP, EP, and residual solvent regulations.
Absolute Ethanol 99%Product Features
Bulk water ≤0.1%; meets USP <631> guidelines
Suitable for paclitaxel co-solvent and other polar API processes
Core Application Scenarios
Solvent in API development and purification
Tablet core dissolution and coating
Preparation of parenterals and injectables
Absolute Ethanol 99% Physical Property Data
| Parameter | Specification | Test Method |
|---|---|---|
| CAS Reg. No. | 64-17-5 | - |
| Empirical formula | C₂H₅OH | - |
| Appearance | Colorless liquid | Visual (ASTM D1209) |
| Boiling point | 78.2°C | ASTM D1078 |
| Density (20°C) | 0.789 g/mL | ISO 3675 |
| Water content | ≤0.1% (w/w) | Karl Fischer (EP 2.5.12) |
| Acidity (as acetic acid) | ≤10 ppm | USP <631> |
Absolute Ethanol 99% Hazards
|
Pictograms |
|
|
Signal word |
Danger |
|
Hazard statements |
H225, H319, H360D |
|
Precautionary statements |
P210, P233, P240, P241, P242, P305+P351+P338 |
|
Flash point |
14 °C (Absolute) |
Absolute Ethanol 99% Molecular Structure
Absolute Ethanol 99% Packing
Pharmaceutical barrels with tamper-evident seals
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