Comparative risk assessment study of elemental impurities in Montelukast chewable tablets and film-coated tablets

• Main Authors: Angelevski Stefan (Author), Slaveska-Spirevska Irena (Author), Lazarevska-Todevska Elena (Author), Bakovska-Stoimenova Tanja (Author), Glavaš-Dodov Marija (Author), Simonoska-Crcarevska Maja (Author), Slaveska-Raički Renata (Author)
• Format: Book
• Published: Pharmaceutical Association of Serbia, Belgrade, Serbia, 2023-01-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

It is well documented that elemental impurities (EIs) are critical in the field of pharmaceutical development since they could affect the quality, efficacy and safety of the finished dosage form (FDF). The responsibility of pharmaceutical manufacturers is to demonstrate via assessment approach, risk...