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 

• Humectant: Stops eye drops, ear drops, creams, gels, or pastes from drying out and maintains an adequate level of skin hydration under transdermal patches.
   
• Solvent: Used in liquid preparations, e.g. syrups or tinctures. 
   
• Plasticizer: Glycerine provides elasticity in capsule shells (especially gelatine capsules). It also softens and makes the adhesive layer of transdermal patches more flexible. 
   
• 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 99.8% 
   
• Glycerine 86% (86% glycerine + 14% 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 86% 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. 

The right certificate is crucial 

Glycerin may have different certifications depending on its intended use. In dietary supplements, medical devices, and cosmetic products, pharmaceutical-grade quality certifications (Ph. Eur., USP, EXCiPACT™) are applicable.  
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. 

Not all glycerine is the same 

Glycerine is an indispensable component of pharmaceutical formulations. Yet whether water-free or 86%, 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.