Name of ingredients Formulation batches OPT/KTM/T-01 OPT/KTM/T-02 OPT/KTM/T-03 Ketorolac tromethamine 5 mg/ml 5 mg/mL 5 mg/Ml Benzalkonium chloride* 0.06 mg/Ml 0.08 mg/Ml 0.1 mg/Ml Disodium EDTA 1.0 mg/Ml 1.0 mg/Ml 1.0 mg/Ml Sodium chloride 7.9 mg/Ml 7.9 mg/Ml 7.9 mg/Ml Octoxynol 40 0.1 mg/Ml 0.1 mg/Ml 0.1 mg/Ml Hydrochloric acid adjust pH adjust pH adjust pH Sodium hydroxide pH 6.5 pH 7.4 pH 8.4 Water for injection QS QS QS

Table 3: Composition of Ketorolac tromethamine Ophthalmic Solution change in pH stability.

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