Recommended Storage

Even if the above-mentioned conservation methods are used, the storage period for water samples is limited. Table 1.2, derived from the current (2003 edition) international ISO standard [14], gives an overview of recommended sampling and storage bottles as well as conservation methods and maximum storage periods for different determinants in the sample. 

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Temperature control is important in the handling and storage of isocyanates. Storage at inappropriate temperatures can cause product discoloration, viscosity increases, and dimerization. Handling personnel should consult the technical data sheets for the recommended storage temperature of the specific isocyanate product. 

Because of its hygroscopicity, fmctose must be properly dried, packaged, and stored to prevent lumping and preserve free-flowing handling. Recommended storage and bulk handling conditions call for conditioned air at a relative humidity of less than 50% and a maximum temperature of 24°C... 

Myrcene Manufacture. An important commercial source for mycene is its manufacture by pyrolysis of p-piaene at 550—600°C (87). The thermal isomerization produces a mixture of about 75—77 wt % myrcene, 9% limonene, a small amount of T -limonene [499-97-8] and some decomposition products and dimers. The cmde mixture is usually used without purification for the production of the important alcohols nerol and geraniol. Myrcene may be purified by distillation but every precaution must be taken to prevent polymerization. The use of inhibitors and distillation at reduced pressures and moderate temperatures is recommended. Storage or shipment of myrcene in any purity should also include the addition of a polymerization inhibitor. 

L-Ascorbic acid is screened or pulverized into a variety of particle sizes. It is usually packaged in 25-kg and 50-kg quantities in standard, polyethylene-lined containers, eg, fiber dmms, cormgated boxes, etc. The recommended storage conditions are low humidity and temperatures of <23 C. 

Bulk alum can be stored in mild steel or concrete bins with dust collector vents located in, above, or adjacent to the equipment room. Recommended storage capacity is about 30 days. Dry alum in bulk form can be transferred or metered by means of screw conveyors, pneumatic conveyors, or bucket elevators made of mild steel. Pneumatic conveyor elbows should have a reinforced backing as the alum can contain abrasive impurities. 

Table 18.1 Recommended storage and handling temperatures for residual fuel oils (based on BS 28618 11870)...

When the use of lagging is being considered, cost-beneht analysis should be made to determine the minimum running costs when either (1) fuel is stored at the minimum recommended storage temperature with an outflow heater to raise the temperature to the minimum handling temperature, or (2) fuel is stored at handling temperature, thus requiring no outflow heater. 

Table 14.1 shows recommended storage conditions for a few basic products. Comprehensive tables will be found in standard works of reference [36, 37]. In the event of a product being encountered which cannot be found in general references, information can often be obtained from agricultural and other research establishments. 

Data to demonstrate the stability characteristics of both the drug substance and the drug product must be collected. Studies using three different batches of both substance and product in their respective containers/packaging must be conducted. Real-time data should be collected under conditions of temperature and relative humidity in line with the recommended storage. Conditions in different world climatic zones must be taken into consideration for cases where normal environmental... 

Whereas commercially manufactured products are required to possess an expirahon date, compounded products are assigned a beyond-use date. There are numerous sources of information that can be used for determining an appropriate beyond-use date, such as chemical companies, manufacturers literature, laboratory data, journals, and published books on the subject. Generally, most pharmacists prepare or dispense small quanhties of compounded products recommend storage at room, cool, or cold temperatures and use a conservative beyond-use date. 

Long-term testing Stability studies under the recommended storage condition for the retest period or shelf life proposed (or approved) are performed with several drug substance batches in the stipulate packaging. In the general case, the storage condition is at a temperature of 25°C and 60% relative humidity. 

For drug substances, a retest date is generally determined. The period up to the retest date is a period during which the material is known to adhere to its specification, for example, for assay or degradants. The retest date may be assigned on the basis of real-time stability data obtained at the recommended storage conditions or on the basis of accelerated stability data obtained under more stressful conditions. 

Assignment of Climatic Zones and Recommended Storage Conditions Stability Testing Parameters for Different Dosage Forms... 

ASSIGNMENT OF CLIMATIC ZONES AND RECOMMENDED STORAGE CONDITIONS... 

World Health Organization (WHO) (2006), Assignment of climatic zones and recommended storage conditions, Working Document QAS/06.179, Annex 1, WHO, Geneva. 

The short-term stability study is conducted over extreme environmental conditions to increase the rate of chemical degradation. The data obtained from short-term stability studies are normally used to evaluate longer term chemical effects at nonextreme storage conditions, but they are also helpful to assess the effect of shortterm excursions outside the recommended storage conditions that might occur during shipping. However, the results from short-term stability studies cannot always... 

It is of interest for the pharmaceutical industry to know the degradation of its drug products at accelerated conditions to assess degradation for longer term storage at nonextreme conditions and short excursions outside of the recommended storage... 

Primary and developmental stability studies help development scientists understand the degradation pathways. These studies are developed to get information on the stability of the drug product, expected expiry date, and recommended storage conditions. All specified degradation products, unspecified degradation products, and total degradation products are monitored in these studies. 

The excipient must be stored following the manufacturers recommended storage conditions. Where temperature or humidity is specified, it is necessary to provide appropriate controls in the warehouse along with records to show compliance. If normal warehousing conditions are appropriate, the warehouse can be kept under ambient conditions and no monitoring of temperature or humidity is required. 

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