作者：locoy 2019-05-27 13:52閱讀：
Accessed from 220.127.116.11 by universetx608 on Tue Oct 17 03:03:43 EDT 2017 534 á659? Packaging and Storage Requirements / Physical Tests USP 40
Medicine dropper: A measuring device consisting of a transparent or translucent barrel or tube that is generally fitted with a collapsible bulb. It may be packaged with oral liquid articles. Oral syringe: A measuring device consisting of a plunger and barrel made of transparent or translucent plastic material and a seal on the end. It may be packaged with oral liquid articles. The syringe should deliver a measured amount of a liquid drug product.
TEMPERATURE AND STORAGE DEFINITIONS
Freezer: A place in which the temperature is controlled between ?25° and ?10° (?13° and 14° F). It is noted that, in some instances, articles may have a recommended storage condition below ?20° (?4° F). In such cases, the temperature of the storage location should be controlled to ±10°. Refrigerator: A cold place in which the temperature is controlled between 2° and 8° (36° and 46° F). Cold: Any temperature not exceeding 8° (46° F). Cool: Any temperature between 8° and 15° (46° and 59° F). [NOTE—An article for which storage in a cool place is directed may, alternatively, be stored and shipped as refrigerated, unless otherwise specified by the individual monograph.] Room temperature (also referred to as Ambient temperature): The temperature prevailing in a working environment. Controlled room temperature: The temperature maintained thermostatically that encompasses the usual and customary working environment of 20°–25° (68°–77° F). The following conditions also apply. Mean kinetic temperature not to exceed 25°. Excursions between 15° and 30° (59° and 86° F) that are experienced in pharmacies, hospitals, and warehouses, and during shipping are allowed. Provided the mean kinetic temperature does not exceed 25°, transient spikes up to 40° are permitted as long as they do not exceed 24 h. Spikes above 40° may be permitted only if the manufacturer so instructs. Articles may be labeled for storage at “controlled room temperature” or at “20°–25°”, or other wording based on the same mean kinetic temperature [see also Good Storage and Distribution Practices for Drug Products á1079?, Quality Management System, Mean Kinetic Temperature (MKT) Calculation]. An article for which storage at Controlled room temperature is directed may, alternatively, be stored and shipped in a cool place or refrigerated, unless otherwise specified in the individual monograph or on the label. Warm: Any temperature between 30° and 40° (86° and 104° F). Excessive heat: Any temperature above 40° (104° F). Dry place: A place that does not exceed 40% average relative humidity at 20° (68° F) or the equivalent water vapor pressure at other temperatures. The determination may be made by direct measurement at the place. Determination is based on NLT 12 equally spaced measurements that encompass either a season, a year, or, where recorded data demonstrate, the storage period of the article. There may be values of up to 45% relative humidity provided that the average value does not exceed 40% relative humidity. Storage in a Container validated to protect the article from moisture vapor, including storage in bulk, is considered a Dry place. Protect from freezing: The Container label will bear an appropriate instruction to protect the article from freezing in cases where freezing exposes an article to loss of strength or potency or to destructive alteration of its characteristics. These risks are present in addition to the risk that the Container may break if exposed to freezing temperatures. Protect from light: Where light subjects an article to loss of strength or potency or to destructive alteration of its characteristics, the Container label bears an appropriate instruction to protect the article from light. The article must be packaged in a light-resistant Container.▲USP40