Stability Testing Uncovers Impurities, Industry Experts See Limited Risk to Other Formulations

Medica Korea is recalling its glimepiride 바카라 필승법 after impurities were detected during stability testing. Despite this, industry experts believe that the issue is unlikely to affect other formulations.
The Ministry of Food and Drug Safety (MFDS) recently issued a recall for six glimepiride-containing 바카라 필승법 manufactured by Medica Korea. These include Lowglico tablets by Medica Korea, Mebid tablets by NBK Pharmaceuticals, Glimedi tablets by Intro Bio Pharma, Glimepiril tablets by Boryung Biopharma, Gripid tablets by i-Cure, and K-ril tablets by KS Pharmaceuticals. Additionally, Newglipild tablets (2mg) by Anguk Newpharm are being recalled due to the suspicion that they were produced by Medica Korea in the past. Medica Korea also produces Glikim tablets for Kim’s Pharmaceuticals using the same process, potentially including them in the recall.
All the recalled 바카라 필승법 were manufactured by Medica Korea in the first half of 2022. At the time of shipment, impurity levels were within acceptable limits, but stability testing later revealed the issue.
Stability testing assesses whether a drug remains stable under typical storage conditions over time. This test is typically conducted after at least six months of storage, as impurities can increase in trace amounts during long-term storage, determining the product's shelf life.
The importance of stability testing was underscored by a similar issue in 2019 with ranitidine, a drug used for gastrointestinal disorders. Storage-related problems were reported, revealing that when stored above certain temperatures, the levels of N-nitrosodimethylamine (NDMA) in ranitidine 바카라 필승법 exceeded acceptable limits.
However, the current issue with glimepiride 바카라 필승법 is believed to be isolated. An industry representative stated, "The affected 바카라 필승법 were all produced by Medica Korea. It is uncommon for impurities to significantly increase during stability testing. The issue likely stems from the active pharmaceutical ingredient."
Given that the detected impurities were concentrated in specific batches produced during a specific period, it is unlikely that this will lead to widespread issues, as seen with ranitidine. Similar recalls have occurred this year for sitagliptin and clopidogrel, though these did not extend across entire drug classes.
The consensus is that the glimepiride issue is limited to specific batches affected by the raw materials used during production. An industry representative added, "Impurities can arise during the production of raw materials or finished pharmaceuticals. The key concern is whether these impurities exceed acceptable limits. While later-produced 바카라 필승법 likely had impurity levels below the threshold, they may have slightly exceeded it during long-term storage. Therefore, the risk of this issue spreading across all formulations is low.