抄録
We have identified a discrepancy in the regulations on ophthalmic solutions and suspensions in the Japanese Pharmacopoeia (JP). The JP regulations specify that there should be no visible particles of foreign matter in any ophthalmic drug product. The JP further specifies that there may not be more than 1 particle of foreign matter of 300μm in size in 1 mL of solution. However, we determined that particles of 50μm in size are visible to the naked eye suggesting that the JP regulations concerning ophthalmic products are contradictory and should be revised.
© 2006 日本医療薬学会