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(a) There shall become a created tests plan built to evaluate The soundness features of drug solutions. The outcome of this sort of steadiness tests shall be used in figuring out correct storage conditions and expiration dates. The prepared program shall be adopted and shall consist of:23. Does FDA consider ophthalmic drug products1 for being adult
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test. Even though no unique Guidance are supplied for its preparation, it ought to not incorporate any detectable direct. Purified Drinking water need to be a suitable substitute for this h2o. Chloride-Totally free Water— This water is specified since the solvent for use within an assay that contains a reactant that precipitates while in the p