01/07/2024
Nepal Pharmaceutical Association - NPA Sudurpashchim province
We wanted to extend our sincere thanks for informing us about the discoloration issue with the paracetamol injections. Your vigilance and prompt communication are greatly appreciated. It appears that the solution turns black or cola-colored when it comes in contact with air (In snaps there is visible leakage residue between the Over pouch and filled bottle). This discoloration is primarily due to the degradation of paracetamol, likely caused by hydrolysis and oxidation.
The reasons for this could include minor leakage (due to very minor leakage, unfortunately it may be skipped by visual inspectors) or wear and tear during transportation and mishandling during storage. It's important to note that this is a characteristic of paracetamol itself and is not due to any fungal contamination, or any negligence during the production activity.
You are doing an excellent job, but I wanted to ensure that you are aware of the actual reasons behind this discoloration. Please update yourself and inform the entire team to prevent any potential confusion or concerns. also refer the link regrading reasons of discoloration in paracetamol.
https://pubmed.ncbi.nlm.nih.gov/26559666/