Name of ingredients Formulation batches OPT/KTM/T-01 OPT/KTM/T-02 OPT/KTM/T-03 OPT/KTM/T-04 OPT/KTM/T-05 OPT/KTM/T-06 Ketorolac tromethamine 5 mg/mL 5 mg/mL 5 mg/mL 5 mg/mL 5 mg/mL 5 mg/mL Benzalkonium chloride* 0.00 mg/Ml 0.05 mg/Ml 0.06 mg/Ml 0.08 mg/Ml 0.1 mg/Ml 0.12 mg/Ml Disodium EDTA 1.0 mg/Ml 1.0 mg/Ml 1.0 mg/Ml 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 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 0.1 mg/Ml 0.1 mg/Ml 0.1 mg/Ml Hydrochloric acid adjust pH adjust pH adjust pH adjust pH adjust pH adjust pH Sodium hydroxide adjust pH adjust pH adjust pH adjust pH adjust pH adjust pH Water for injection QS QS QS QS QS QS

Table 2: Composition of different concentration BKC in Ketorolac tromethmine Ophthalmic Solution.

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