Individual excipients used in Paroxetine Tablets 5 mg “Meiji” conforms to the requirements of the official compendium. Sodium starch glycolate, Magnesium stearate, Hypromellose 2910, Titanium oxide, Macrogol 400, Polysorbate 80 and Carnauba wax are controlled by the analytical methods stipulated in JP and the qualities conform to the specification requirements of JP. Dibasic calcium phosphate fine granulated and Red ferric oxide are listed in The Japanese Pharmacopoeia Excipients (JPE) and the qualities conform to the specification requirements of JPE.
The specification and test methods for the excipients are attached from the next page. Representative certificate of analysis of each excipient is also enclosed.