Pharmaceutical quality counts: Glycerine and its regulatory requirements

Glycerine, also known as glycerol, is a colourless, odourless, viscous and sweet-tasting trihydric alcohol. It is one of the most important excipients in the pharmaceutical industry – versatile and available in many quality grades. But not all glycerine is the same: differences in water content and certifications play a key role in its application and regulatory approval.

Applications of glycerine in the pharmaceutical industry

Glycerine fulfils a number of functions in pharmaceutical products:

Humectant:

Stops creams, gels, or pastes from drying out.

Solvent:

Used in liquid preparations, e.g. syrups or tinctures.

Plasticizer:

Glycerine provides elasticity in capsule shells (especially gelatine capsules).

Sweetener:

It serves as a mild alternative sweetener in sugar-free medicines.

Lubricant:

In suppositories for better application.

Stabilizer:

Protects the active ingredients from drying out or decomposing.

Water content: when is which glycerine better?

Glycerine is hygroscopic – it draws water from its environment – and has a different water content depending on how it was manufactured.

The two most common variants are:

• Water-free glycerine 99.5%
• Glycerine 85% (85% glycerine + 15% water)

Choosing by application:

• Water-free glycerine is especially suitable for:
  • Applications where water is undesirable (e.g. sensitive reaction systems, lipophilic systems).
  • Manufacturing gel capsules, where too high a water content could destabilize the gelatine.
  • Long shelf-life products, where water would be a microbiological risk factor.
     
• Glycerine 85% is often sufficient and more cost-effective:
  • In syrups or aqueous solutions where water is already present.
  • For non-sterile formulations with adequate preservation.

The choice therefore depends heavily on the galenic form, desired pH, water compatibility of the active ingredients, and microbiological stability.

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The right certificate is crucial

Glycerine can have different certifications depending on its intended use. Common certifications are food grade (E422) for use in food and dietary supplements and pharmaceutical grade (Ph. Eur., USP, Excipact) for cosmetic and medicinal applications. 

An Excipact certificate is important above all for companies who rely on a documented, auditable and GMP-compliant supply chain – especially in regulated markets such as the EU, USA, or Japan.

Excipact-certified glycerine is recommended in the following cases:

Pharmaceutical manufacturing under GMP guidelines:

When glycerine is used as an excipient in pharmaceuticals, many regulatory authorities require proof of quality assurance from the excipient manufacturer. Excipact serves as an internationally recognized audit standard that certifies GMP and GDP compliance for excipients (Good Manufacturing/Distribution Practice).

Less hassle for being audit-ready:

Companies that don’t have the capacity or resources to conduct their own regular supplier audits can rely on the Excipact certificate. It saves time and costs for supplier qualification and for der GxP documentation.

Manufacturing products under high levels of regulatory scrutiny:

When producing parenteral, inhalable, or other sensitive forms of medicines, authorities are especially strict on maintaining highest quality in every step of production – including excipients.

Sales in international markets:

Excipact is recognized worldwide. It simplifies marketing in many countries by meeting the regulatory requirements of many markets.

In short: If you manufacture pharmaceutical products and use glycerine as an excipient, an Excipact certificate not only offers legal certainty, but also professional proof of quality, which builds trust with customers and authorities.

Summary: Not all glycerine is the same

Glycerine is an indispensable component of pharmaceutical formulations. Yet whether water-free or 85%, whether EP or Excipact – the exact specification must be right for the application. While water content is a primary consideration from a technical standpoint, certifications are crucial in regulatory approval and product safety. Especially in a pharmaceutical context, quality, traceability, and GMP compliance are not optional, but mandatory.