Document

Quality of Diclofenac Sodium Tablets
  • 29.12.2020
  • 52,830
Quality of Diclofenac Sodium Tablets
Owner / Producer Owner / Producer
Piyamas Kijchanapanich, Sasida Yoosook
Year Year
2020
Pages Pages
1
Details

Diclofenac Sodium tablet is a nonsteroidal anti-inflammatory drug (NSAID). It is used to treat mild to moderate pain, inflammatory of osteoarthritis, rheumatoid arthritis and acute gout attack. In the fiscal year 2019, Bureau of Drug and Narcotic collaborated with Food and Drug Administration Thailand randomly collected samples from manufacturers, importers and hospitals under Quality Assurance of Medicine program. A total of 23 samples with strength of 25 and 50 mg from one importer (1 registration number) and 8 local manufacturers (9 registration numbers) were evaluated according to the United States Pharmacopoeia (USP 41) for identification, assay, content of uniformity, dissolution and organic impurities. The analytical methods were verified prior to analysis. The survey showed that 21 samples (91 percentage) complied with the USP 41 specifications whereas only 2 samples failed in dissolution. These data will be published in the GREEN BOOK.

Key words : Diclofenac Tablet, Diclofenac sodium, NSAID