According to the FDA (2024–2025 nitrosamine guidance), propyl gallate is one of the approved antioxidants that can be added to drug formulations to reduce or prevent nitrosamine formation. The FDA states that reformulated products may include: “specific antioxidants (like ascorbic acid, alpha tocopherol, cysteine hydrochloride, and propyl gallate) within acceptable limits (≤10 mg per dose)” to reduce nitrosamine impurities. According to the FDA (2024–2025 nitrosamine guidance), propyl gallate is one of the approved antioxidants that can be added to drug formulations to reduce or prevent nitrosamine formation. The FDA states that reformulated products may include: “specific antioxidants (like ascorbic acid, alpha tocopherol, cysteine hydrochloride, and propyl gallate) within acceptable limits (≤10 mg per dose)” to reduce nitrosamine impurities.
About Propyl gallate GMP
Minakem has been actively involved in the industrial production of high-quality propyl gallate for more than a decade.
Minakem’s propyl gallate is manufactured in state-of-the-art cGMP facilities, and complies with the American, European pharmacopoeias.
- 2 forms available :
- Propyl Gallate ref#700121
- Milled Propyl Gallate ref#700122 with PSD on COA.
- Propyl Gallate is produced according to a validated GMP process.
- Packaging : 5 and 20 kg
- Production : Multi-tons scale
- Stability : Retest after 4 years if kept in the original, unopened packaging.
Therapeutical Class and Mechanism of Action
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, adhesive, lubricants). Recent studies now revealed that propyl gallate has an effective inhibitory effect on the formation of Alkyl-Aryl and Dialkyl N-Nitrosamine Derivatives 1, 2
1 Processes, 2022, 10, 242 – 2 Org. Process Res. Dev. 2023, 27, 3, 394
Frequently Asked Questions
One of the reference study has been published in 2022 by Miha Homšak and al. (Sandoz Development Center Slovenia / Lek Pharmaceuticals) https://www.mdpi.com/2227-9717/10/11/2428
Yes, the propyl gallate is manufactured by Minakem according to the cGMP for more than 15 years. Minakem is indeed manufacturing propyl gallate since the 80s. The first cGMP grade of propyl gallate has been manufactured by Minakem in 2012. Minakem is now offering 2 grades with different PSD to adjust its offering to the customers’ needs.
https://jpharmsci.org/article/S0022-3549%2823%2900142-9/fulltext
Yes, the propyl gallate is manufactured by Minakem according to the cGMP for more than 15 years.
Minakem is indeed manufacturing propyl gallate since the 80s.
The first cGMP grade of propyl gallate has been manufactured by Minakem in 2012.
Minakem is now offering 2 grades with different PSD to adjust its offering to the customers’ needs.