| dc.description.abstract | Introduction
Acetaldehyde (AA) is a volatile compound that belongs to a large family of aldehydes, a class of organic chemicals containing a formyl group (Andrea Re Depaolini, 2020). Acetaldehyde occurs widely in nature but can also be produced on a large scale in industry mainly as an intermediate during the manufacture of other chemicals and in the synthesis of flavors and fragrances (Ali, 2020; Andrea Re Depaolini, 2020; Azra, 2012). Naturally, AA is present in many ripe fruits such as apples, grapes, and citrus fruits as well as in the roasted coffee beans, essential oils, wines and other food stuffs (Chemicals Evaluation and Research Institute (CERI), 2007). At low levels, acetaldehyde gives a pleasant fruity aroma but at high concentrations it has a pungent irritating smell (Danowski, 2003).
The International Agency for Research on Cancer (IARC) and the World Health Organization (WHO) concluded in October 2009, that acetaldehyde is a possible human carcinogen (Straif, 2009). Cell cultures and animal experiments show that acetaldehyde is a mutagen and carcinogen, since it can cause point mutations and form covalent bonds with DNA (Andrea Re Depaolini, 2020). AA is a degradation product of the PET polymer generated during preform production which later migrates into the medicinal products during filling and storage.
Objectives
The purpose of this study was to evaluate the migration of acetaldehyde into selected medicinal products on the Ugandan market the major objective of which was to determine the levels of acetaldehyde in such products.
Methods
Acetaldehyde being a volatile compound was analyzed using the gas chromatography technique. The carrier gas used was Helium at a flowrate of 1.5mL/min. Flame Ionization Detector was used to detect the analytes since AA can be vaporized without decomposition. Fused silica gel was used in the column as the stationary phase.
The concentration of acetaldehyde was determined by establishing a calibration curve using acetaldehyde of high grade. The calibration curve provided the relationship between the concentration and the integrated area below the peak for each chromatogram. The area of the chromatogram obtained for each of the samples below the peak was determined and used to obtain the concentration of acetaldehyde from the calibration curve. Analysis of data was done using ChemStation software.
Results
The concentration of acetaldehyde that was determined from the medicinal products ranged from 69 to 85ppm. However, the mean concentration of acetaldehyde in each brand of medicinal product increased in the order E<C<B<A<D. The mean concentration of acetaldehyde for each group of samples ranged from 68ppm to 81.2ppm.
Conclusion
The amounts of AA determined in the representative samples of medicinal products were too low to pose a health risk to the population.
Recommendation
Manufacturers of medicinal products need to be certain of the levels of AA present in the PET bottles received by either carrying out in-house analysis to quantify AA levels or sub-contracting the analysis of AA to another competent laboratory as a precaution to ensure that the levels of AA in the products are within the recommended safety margin.
NDA as a regulator needs to request necessary documentation pertaining the packaging material whose material of construction is PET. This can be a measure to ensure that the requirement of container system suitability is met and that the primary material used to package the medicinal preparations is close to being inert. | en_US |
