USP storage conditions Storage under stricter conditions than required is normally permitted if appropriate for the substance. Requesting a new certificate of analysis for any chemical that is nearing its retest date is a good way to stay safe with these types of chemicals, since this certificate will show whether or not the chemical has been retested and passed the test. Diethyl ether and similar chemicals can form dangerous peroxides over the course of years that can explode on contact if disturbed. Less complex methods can be used to determine the shelf life. When this date has been reached, the substances must be disposed of or their quality must be retested. Refrigerated liquid chemicals may last quite a bit less time than solids, with some chemicals having recommended expiration dates of as little as 12 to 18 months. They must be stored in climatically controlled rooms or storage areas. How is the shelf life determined? However, what could be a suitable answer if an auditor asks for backup data for this practice. The shelf live can be assigned based on the result.
As in the case for standard substances, the accompanying supplier documentation is the main point of reference. In accordance with ICH Q2B, the stability of solutions influences the analytical method and must be examined as part of the robustness. It is always acceptable to err on the side of caution if contamination is considered highly likely. Certain highly sensitive chemicals must be stored under a protective gas, e. It is also important to know of expiration dating exceptions for your lab. Validated stability indicating methods must be used for this purpose. Under less than ideal conditions, like after the bottle's seal has been broken or if the chemical has been transferred to a different container, the chemical will move closer to the point of needing to be disposed of. Sorry this not reply but question, itself.. Markus Limberger Standard substances Standard substances are stored in accordance with the instructions in the certificate or accompanying documentation. Check the Retest Date Many chemical manufacturers only include a Recommended Retest Date on their bottles, which can seem like a mixed bag at first. These chemicals should be monitored very closely and their expiration dates adhered to down to the minute so they can be safely disposed of before they cause an explosion or other accident. Assigned 5 year shelf life should be data based, not simply assumed. Triumvirate helps its clients manage high-haz chemicals compliantly and cost-effectively. Strongly hygroscopic substances must be stored in a desiccator and light-sensitive substances in darkness. USP storage conditions Storage under stricter conditions than required is normally permitted if appropriate for the substance. While not necessarily a date by which you should throw out the chemical, this is a date by which the manufacturer should have retested the chemical batch to ensure its safety and quality. A qualified chemical storage specialist will be able to give you a better idea of exactly how long a given chemical will last based on known expiration dates of similar chemicals or previous knowledge of the specific chemical in question. The expiry date must be indicated on every standard substance and reagent and — where necessary — the shelf life after opening. Also, our auditor inspections as well have resulted in the accepted verbiage that an expired STANDARD could be used only if validation methods were in place to prove its integrity still fell within the standard's original limits prior to every usage beyond expiration. Expiration dates are most important in chemicals that can form salts or other precipitates over time, like diethyl ether. For such cases, err on the side of caution with expiration dates that remain within degredation limits. If information about the shelf life is not available, it must be determined using suitable tests and stability storage for a defined range cf. Another option is the use of a risk analysis to prove that ageing of the reagent does not affect the result. In order to minimise the impact of environmental conditions or freezing and thawing on the quality of a substance, the smallest possible containers or portions should be stored. This can be scientifically argued, or proven using quotations from the literature or experimentation. Shelf lives are normally defined based on the information in the certificate or accompanying supplier documentation. Learn more in the link below.
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