Propyl gallate, also known as 3,4,5-Trihydroxybenzoic acid propyl ester or n-Propyl Gallate, is the ester of gallic acid and propanol with the following characteristics :
The structure of propyl gallate includes three hydroxyl groups attached to an aromatic ring, which are crucial for its antioxidant properties.
Propyl Gallate is mainly used as an antioxidant product with a well-known safe effect on food, cosmetics and pharmaceuticals products. More recently, his role as an inhibitor of nitrosamines formation has also been reported.
Minakem is a CDMO with over 20 years of experience in the pharmaceutical industry with 4 manufacturing sites & 3 R&D centers in France, Belgium and Canada approved by the local Health Authorities (ANSM, FDA, etc…).
Propyl Gallate is manufactured on a multi-ton industrial scale in state-of-the-art cGMP facilities located in northern France (Beuvry-la-Forêt). With over 10 years of experience in industrial production and a long-term strategic commitment to this high-quality product, we ensure continuity, security of supply and robust stability (Retest date: 4 years).
2 grades are available:
Both grades are produced according to a validated GMP process and comply with the US and EU Pharmacopoeia monographs.
Propyl Gallate is a well-known safe and powerful antioxidant to protect oils, fats and sensitive ingredients from oxidation in pharmaceutical, food and cosmetic products1. The antioxidant mechanism of propyl gallate primarily revolves around its ability to neutralize free radicals. Free radicals are unstable molecules with unpaired electrons, which can cause oxidative damage by stealing electrons from other molecules, leading to chain reactions that damage cell, proteins, lipids, and DNA. Propyl gallate intervenes in this process by donating hydrogen atoms from its hydroxyl groups to free radicals. This donation stabilizes the free radicals by pairing their unpaired electrons, effectively terminating the chain reactions.
The nitrosamine risk is a major concern in the pharma industry as illustrated by the growing number of publications and patents on the subject. Propyl gallate is a well-known additive to protect oils and fats in products from oxidation and is used in many industries (food, cosmetics, pharmaceuticals products). Recent studies now revealed that propyl gallate has also an effective inhibitory effect on the formation of Alkyl-Aryl and Dialkyl N-Nitrosamine Derivatives 2
1 Int J Toxicol. 2007;26 Suppl 3:89-118
2 Processes, 2022, 10, 2428
From health and safety concerns, Propyl Gallate has been widely evaluated through toxicological studies and reviewed by health organizations. It is considered as a safe excipient when it is used at low concentrations in food, cosmetics and pharmaceuticals products.
Classification of substance and labelling according to CLP regulations (update May 2026) is :
Propyl gallate is a well-established pharmaceutical excipient with broad regulatory acceptance across most major markets worldwide. Its use in medicinal products is supported by official pharmacopoeia standards and regulatory databases, reflecting an extensive history of evaluation and use in approved drug products.
In the European Union, propyl gallate is described in the European Pharmacopoeia (Ph. Eur., monograph 1039), which constitutes the legally recognized quality standard for excipients used in medicinal products for human use. Compliance with the European Pharmacopoeia supports its acceptability in EU authorized medicines in accordance with Directive 2001/83/EC.
In the United States, propyl gallate is compliant with US regulatory requirements and is listed in the FDA Inactive Ingredient Database (IID), confirming its use in FDA approved drug products for specific dosage forms, routes of administration, and use levels. When manufactured and controlled in accordance with the applicable USP–NF (United States Pharmacopeia–National Formulary) monograph, propyl gallate is considered USP compliant and suitable for use in pharmaceutical formulations intended for the US market.
Recently, FDA mentioned in a specific workshop on “Advancing Generic Drug Development: Translating Science to Approval – Session 4 Nitrosamines” that For BCS I–III drugs, no new bioequivalence study is required if:
*This presentation reflects the views of the author and should not be construed to represent FDA’s views or policies.
For detailed technical, quality and safety information regarding Propyl Gallate, please refer to the official documentation available below.
Download the Product Data Sheet (PDS)
Comprehensive overview of product specifications, physico-chemical properties, grades and applications.
Download the Safety Data Sheet (SDS)
Full safety, handling, storage and regulatory information in accordance with EU REACH and CLP regulations.
The product PROPYL GALLATE GMP is put into 2 polyethylene bags, both packed in a plastic drum/Keg.
Desiccants are put between the inner bag and outer bag
The product is stored at room temperature and dry conditions.
When products are in stock the usual lead time is about 1 month after receiving the PO.
If products are not in stock it can be up to 6 months.
Please find below a document summarizing all our available quality certificates: Propyl_Gallate_quality_certificate_available
