Regulations time required

OSHA regulations define specific time requirements for investigating any release or potential release of any chemical that is within the scope of 29 CFR 1910. 

The time required to fully establish the safety and efficacy of a new drug in the eyes of the regulatory authority might not always be to the benefit of the proposed patient group. This is particularly so in the case of drugs intended to treat serious or life-threatening diseases where no effective therapy currently exists. Various provisions have been incorporated into the regulations to allow accelerated access to such therapies. 

The protocol will provide important date and time requirements. Estimated start and completion dates for the study are required by regulation. In addition, the Study Director may specify a maximum storage time of the RAC prior to processing if the chemical in question or its metabolites degrade rapidly. A maximum time after generation of a processed fraction before that fraction is placed into frozen storage may also be specified. A maximum storage time prior to shipment may also be specified. 

The total time required for the oxidation is twenty-four hours. It is convenient to start the reaction in the morning. In this way the last part of the reaction, which requires no attention, will be accomplished during the night. The regulation of the temperature is necessary, as the reaction proceeds very slowly below 200 on the other hand, the dichloroacetone itself is oxidized at a somewhat higher temperature than 250. 

Calibration at a flow rate other than the flow rate associated with the adsorption or desorption peaks can lead to serious errors because the width of the peaks and therefore the peak areas are directly proportional to the flow rate. A good two-stage pressure regulator and needle valve provide adequately constant flow rates over the short time required for desorption and calibration. 

The reaction mixture is then cooled by an ice-salt mixture. The separatory funnel is replaced by a two-hole rubber stopper containing a thermometer (bulb immersed in the reaction mixture) and a glass tube drawn out to make a fine capillary (Note 5). When the temperature of the reaction mixture has reached — 7°, the condenser is replaced by an entry tube, 10 mm. in diameter and adjusted so the end is about 50 mm. above the surface of the reaction mixture (Note 6). The reaction mixture is stirred, and dry carbon dioxide is added through this tube (Note 7). The rate of flow of the carbon dioxide is regulated so that the temperature of the reaction mixture does not rise above —2°. The time required for the completion of the reaction varies from one and one-fourth to one and one-half hours. When the reaction is complete, the temperature falls below —7° and does not rise on increasing the rate of flow of carbon dioxide. 

A shaking device, near the bottom, is regulated in such a manner that the rate of discharge and consequently the volatile content of the proplnt, is controlled by the speed atwhichthis shaker is operated and by the amt of clearance betw the shaker and the bottom of the shute. The time required for drying is betw 4 and 5 hrs. One of the installations operating in the US before WWII was capable of drying to correct moisture and volatile contents 100000 lbs of 75 mm pro-pint in 24 hrs... 

Delayed many projects because of the time required to comply with NEPA regulations. 

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