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The product should be stored away from locations where excessive or variable heat, cold, or light prevails, such as those near heating pipes or fluorescent lighting. In the absence of specific instructions, the product should be stored at controlled room temperature (see Storage Temperature in the General Notices). Where a product is required to be protected from light and is in a clear or translucent container enclosed in an opaque outer covering, such outer covering is not to be removed and discarded until the contents have been used. Supplemental instructions, such as a direction to protect the product from light, also should be followed carefully. They may include a specified temperature range or a designated storage place or condition (e.g., “refrigerator,” or “controlled room temperature”) as defined in the General Notices. In most instances, the recommended storage conditions are stated on the label, in which case it is imperative to adhere to those conditions. Storage under Recommended Environmental Conditions— Such a study, in combination with clinical and toxicological results, enables the manufacturer to select the optimum formulation and container and to assign recommended storage conditions and an expiration date for each dosage form in its package. At appropriate time intervals, samples of the product are assayed for potency by use of a stability-indicating method, observed for physical changes, and, where applicable, tested for sterility and or for resistance to microbial growth and for toxicity and bioavailability. From this information, one or more formulations of each dosage form are prepared, packaged in suitable containers, and stored under a variety of environmental conditions, both exaggerated and normal. Ordinarily the formulator of a product first determines the effects of temperature, light, air, pH, moisture, trace metals, and commonly used excipients or solvents on the active ingredient(s). The scope and design of a stability study vary according to the product and the manufacturer concerned.