Benzene has been found to be present in a number of aerosol drug products, certain aerosol consumer and cosmetic products, and in ethanol based hand sanitizers. This contamination may be related to the use of benzoate salts as preservatives, carbomer thickening agents, the propellant isobutane, and certain denatured alcohols (SD alcohols) either contaminated or inappropriately denatured (adulterated) with benzene. Also, levels of this contaminant can be introduced to products at one or more stages of a product’s lifecycle, including through
- Use of contaminated raw materials or formation of byproducts in manufacturing
- Introduction of contaminants during processing or storage
- Leaching of contaminants from packaging materials or other materials in direct contact with the product during manufacturing, shipping, or storage
- Formation of contaminants through degradation of product components, during shipping, storage, or as a result of unusual or unexpected exposure to environmental conditions.
Benzene is a known human carcinogen, classified as a Class 1 Residual Solvent. FDA has established a regulatory limit of 2 ppm benzene as a residual solvent in drug products, consistent with the recommendations described in ICH Q3C. However, a variety of product use factors determine the toxicological risks, including exposure route, amount and frequency of use, and duration of use.
How Quantum Can Help
Quantum Analytics Group has a long history of assisting manufacturers in addressing potential issues with their products. These have ranged from dealing with issues involving raw materials, product components, product quality, and product failure, to potential contaminant issues, such as 1,4-dioaxne, nitrosamines and benzene.
Our laboratory is equipped with multiple Headspace GC and Headspace GC-MS instruments, including tandem ms/ms. Headspace analysis is the technique for identifying and measuring concentrations of residual solvents, such as benzene, in drug products and components, consumer products, and personal care and cosmetic products. And, Headspace GC-MS is the method of choice for both unambiguously identifying and measuring concentrations of benzene at very low parts-per-million to parts per billion levels.
Our testing and analytical services are designed to solve your product questions:
- Quality – Determining if benzene is present
- Verifying – If found present, confirming that it is benzene, and at what level.
- Product – Supporting identifying the source of benzene, in products, actives/API, inactives/excipients. raw materials, components, and packaging.