Ethanol 96% v/v for pharmaceutical excipients (Ph.Eur., BP, USP IPEC Grade) | Clyzo

14-08-2026

Not every pharmaceutical application requires injectable-grade rigor but that doesn't mean quality standards can be relaxed. Clyzo's Ethanol 96% v/v IPEC Grade is manufactured in line with Ph.Eur., BP, and USP monographs and produced under the IPEC (International Pharmaceutical Excipients Council) Good Manufacturing Practice framework, purpose-built for excipient use across oral, topical, and general pharmaceutical manufacturing.

What Is IPEC-Grade Manufacturing?

IPEC-GMP is a quality framework specifically developed for pharmaceutical excipientsthe "inactive" ingredients that nonetheless play a critical role in drug formulation, stability, and performance. Unlike API-GMP, which is built around active ingredient synthesis, IPEC-GMP addresses the realities of excipient production: often produced in larger volumes, sometimes shared with food or industrial-grade lines, but requiring dedicated controls to prevent cross-contamination and ensure batch-to-batch consistency.

Clyzo's Ethanol 96% IPEC Grade is manufactured with:

Segregated or validated shared production lines with documented cleaning and changeover procedures
Full batch traceability from raw material sourcing to finished goods
Pharmacopoeial compliance to Ph.Eur., BP, and USP monographs for ethanol
Excipient-specific quality agreements and change-notification protocols, so customers are informed of any process changes that could affect their formulations

Typical Applications

Solvent and vehicle in oral liquid formulations (syrups, tinctures, elixirs)
Extraction solvent for botanical and herbal pharmaceutical ingredients
Excipient in topical and dermatological formulations
Processing aid in tablet and capsule film-coating operations
General-purpose pharmaceutical-grade solvent in non-parenteral manufacturing

IPEC Grade vs. Injectable Grade — Which Do You Need?

The key distinction is route of administration and associated risk profile. Injectable-grade ethanol such as Clyzo's Ethanol 96% Injectable Grade and Ethanol 99% Injectable Grade carries additional endotoxin and bioburden controls appropriate for products that bypass the body's natural defenses. If your formulation is oral, topical, or otherwise non-parenteral, IPEC grade delivers full pharmacopoeial compliance at a more accessible cost point, without the added specifications that injectable use demands.

If your process instead requires a fully anhydrous, low-endotoxin solvent but isn't strictly for injectable use, our Ethanol Absolute, low endotoxin, IPEC grade bridges that gap.

Documentation and Traceability

Every Clyzo IPEC-grade shipment includes a Certificate of Analysis, IPEC-GMP compliance statement, and supporting documentation such as TSE/BSE declarations. Customers requiring additional documentation for regulatory submissions can request excipient master files or quality agreements directly from our regulatory affairs team.

Looking for reliable, pharmacopoeial-grade ethanol for your excipient needs?

Get in touch with Clyzo for a quote, CoA sample, or technical consultation.

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