Ethanol 96% is a critical solvent in the pharmaceutical industry due to its high purity, low toxicity, and excellent solvency. Its consistent performance and ease of removal make it ideal for processes that require clean, contaminant-free conditions, especially in the formulation of oral, topical, and injectable drugs.
Why Ethanol 96% Is Preferred in Pharmaceutical Production
The pharmaceutical industry requires solvents that are safe, predictable, and compatible with a wide range of active pharmaceutical ingredients (APIs). Ethanol 96% meets these criteria and is widely approved by regulatory agencies such as the FDA and EMA.
It is used for:
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Dissolving APIs during formulation
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Extracting plant-based compounds
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Sterilizing surfaces and equipment
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Acting as a carrier in tinctures and elixirs
Clean Evaporation and Low Residue
One of ethanol’s greatest advantages is its volatility and clean evaporation, leaving minimal or no residue in the final drug product. This property is essential in tablet coating, injectable preparation, and syrup production, where solvent traces must be tightly controlled.
Compatibility and Safety
Ethanol 96% is well-tolerated in pharmaceutical applications and is considered safe for ingestion in regulated amounts. Its broad compatibility with excipients, stabilizers, and preservatives allows for flexibility in product design, whether for over-the-counter formulations or prescription medications.
Regulatory and Quality Standards
Pharmaceutical-grade ethanol is manufactured under strict quality control systems. It must meet standards such as:
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USP (United States Pharmacopeia)
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BP (British Pharmacopoeia)
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EP (European Pharmacopoeia)
These standards ensure it is free from impurities like methanol or aldehydes, making it suitable even for sensitive dosage forms.
Conclusion About Ethanol 96% in Drug Manufacturing
In modern drug manufacturing, ethanol 96% is more than just a solvent—it’s a critical enabler of purity, process consistency, and patient safety. Its versatility and clean profile make it a trusted component in the development and scaling of pharmaceutical products.
As a global exporter, Shetab Gostar Nadin Trading Co. offers high-purity ethanol 96% tailored for pharmaceutical industry needs, ensuring compliance, safety, and efficient delivery.
