Ethanol 99% Injectable Grade: USP, Ph.Eur., BP, JP & GMP Guide | Clyzo

14-08-2026

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For formulators who need a higher-assay ethanol without going all the way to absolute (anhydrous) alcohol, Clyzo's Ethanol 99% Injectable Grade offers a near-anhydrous solvent manufactured under GMP conditions and compliant with USP, Ph.Eur., BP, and JP monographs.

Why Assay Matters in Injectable Formulations

In parenteral manufacturing, even small variations in water content can affect:

Drug solubility many APIs are sensitive to the water/ethanol ratio, and a shift of even 2–3% can push a formulation out of its validated solubility window.
Stability and degradation kinetics hydrolytically unstable actives often require a low-water environment to maintain shelf life.
Sterile filtration and processing higher ethanol concentrations can influence membrane compatibility and filtration validation during aseptic processing.

Clyzo's 99% grade is designed for exactly these situations where 96% ethanol carries too much residual water, but full anhydrous absolute ethanol isn't strictly necessary.

Quality and Regulatory Profile

Multi-pharmacopoeia compliance: USP, Ph.Eur., BP, and JP monographs are all satisfied by a single specification, simplifying multi-market registration.
GMP-certified manufacturing: full batch traceability, validated processes, and change-control documentation.
Tightly controlled impurities: aldehydes, methanol, non-volatile residue, and heavy metals are all held within pharmacopoeial limits.
Injectable-grade microbiological control: bioburden and endotoxin testing appropriate for use in parenteral-adjacent manufacturing environments.

Common Uses

Co-solvent for parenteral and specialty injectable formulations
Solvent for API purification and recrystallization in GMP environments
Vehicle in lyophilized (freeze-dried) product formulations where residual moisture control is critical
Cleaning and rinsing solvent in aseptic filling lines where pharmacopoeial-grade ethanol is mandated

How It Compares to Other Clyzo Ethanol Grades

Choosing between Clyzo's ethanol grades comes down to your formulation's water tolerance and regulatory intent:

Grade	Typical Use Case
Ethanol 96% Injectable Grade	Standard parenteral co-solvent, azeotropic concentration
Ethanol 99% Injectable Grade	Lower water tolerance formulations, near-anhydrous requirement
Ethanol Absolute, low endotoxin, IPEC grade	Fully anhydrous applications, high-sensitivity APIs
Ethanol 96% v/v IPEC Grade	Non-injectable excipient use, oral/topical formulations

Documentation Clyzo Provides

Each batch ships with a Certificate of Analysis, GMP compliance certificate, and where required a Drug Master File reference, CEP, TSE/BSE statement, and residual solvents declaration per ICH Q3C. Our regulatory team can tailor documentation packages to your target market's requirements.

Need Ethanol 99% Injectable Grade for your next batch?

Contact Clyzo's technical sales team for CoAs, sample documentation, and pricing.

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