Stability storage labels

Application of stability results Labeling of storage conditions Retest or expiration dating period Shipping and warehousing conditions Preparation, review, approval, and revision Stability coordinator, laboratory head, QA, and others as appropriate... 

Dichloroethylene is usually shipped ia 208-L (55 gal) and 112-L (30 gal) steel dmms. Because of the corrosive products of decomposition, inhibitors are required for storage. The stabilized grades of the isomers can be used or stored ia contact with most common constmction materials, such as steel or black iron. Contact with copper or its alloys and with hot alkaline solutions should be avoided to preclude possible formation of explosive monochloroacetylene. The isomers do have explosive limits ia air (Table 1). However, the Hquid, even hot, bums with a very cool flame which self-extiaguishes unless the temperature is well above the flash poiat. A red label is required for shipping 1,2-dichloroethylene. 

The stability of [3, 5, 7,9-3H]folic acid (Fignre 10.10) was analyzed to determine whether the varied and conflicting resnlts regarding the characteristics of folate transport in L1210 cells conld be due to impurities in the labeled snbstrate [19]. The susceptibility of [3, 5, 7,9-3H]folic acid to decomposition during storage at -20°C... 

Worker safety studies are not likely to normally include a control substance (i.e., a material used in the study to serve as basis of comparison with the test substance). However, if a control substance is included as a treatment group, then it must (1) be fully characterized as to its identity, purity (or strength), and stability (and solubility, if appropriate) (2) be appropriately tested in mixtures with any carrier used and (3) meet all the other GLP recordkeeping, labeling, and storage requirements, as specified for the test substance. There is some regulatory relief here, however, in that water, by definition, is excluded from being considered a control substance, and vehicles (those substances added to enhance solubilization or dispersion of the test substance) are addressed separately in the FIFRA GLP Standards. 

For each of these you need to consider a number of aspects, such as grade, labelling, preparation, containment, storage, safety, stability and disposal. Each one of these is considered in the next section. Much of the advice given in this section is also applicable to samples. 

Evidence of the stability and recovery of the seeds and banks should be documented. Storage containers should be hermetically sealed, clearly labelled and kept at an appropriate temperature. An inventory should be meticulously kept. Storage temperature should be recorded continuously for freezers and properly monitored for liquid nitrogen. Any deviation from set limits and any corrective action taken should be recorded. 

Labeling requirements in 58.105(c) are not controversial and are the minimum to ensure against mix-up of test or control articles. The Expiration date needs to be included on the label only if one has been established. Some laboratories include a retest date on the label as a reminder of the need for periodic stability analyses. Only special storage conditions (e.g., refrigerate, protect from light, protect from freezing ) need to be included on the label. 

A storage statement for the finished API should be prepared in compliance with the national and regional requirements. The established retest period, which is supported by the stability data, should be displayed on the certificate of analysis (COA) and as appropriate on the container label also. 

A storage statement should be established for the labeling in accordance with relevant national and regional requirements. The statement should be based on the stability evaluation of the drug substance. Where applicable, specific instructions should be provided, in particular for... 

Stability testing of the drug product after constitution or dilution, if applicable, should be conducted to provide information for the labeling on the preparation, storage condition, and in-use period of the constituted or diluted product. This testing should be performed on the constituted or diluted product through the proposed in-use period on primary batches as part of the formal stability... 

Supporting Data — Data, other than those from formal stability studies, that support the analytical procedures, the proposed retest period or shelf life, and the label storage statements. Such data include (1) stability data on early synthetic route batches of drug substance, small-scale batches of materials, investigational formulations not proposed for marketing, related formulations, and product presented in containers and closures other than those proposed for marketing (2) information regarding test results on containers and (3) other scientific rationales. 

To ensure safe and effective finished drug products, the excipients must be stable. Some excipients may be stable and may not require extensive testing, while others may be less stable and require more scrutiny. A retesting or expiration date should be identified on the container label and the COA of the raw material at the time of use. Expiration or retest dates should relate to any storage conditions stated on the label and should be supported by appropriate stability studies. 

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