Avoid storage under extremes of temperature and in an environment with undue fluctuations in temperature

and participate contamination Storage. Avoid storage under extremes of temperature and in an environment with undue fluctuations in temperature Labelling The label states (1) the narne(s) of the active ingredientjs), (2J the total amount of the active ingredrentjs) in the container (in the case of metered-dose preparation for inhalation), (3) that the container should be shaken before use, (4) the other instructions for use, (5) the date after which the preparation is not intended to be used. (6) the conditions under which it should be stored; (7) a warning that the container is under pressure and that it must not be punctured, broken or incinerated even when apparently empty, (8) the statement- "Warning Keep away from children" in me case of metered-dose aerosols, the label states in addition (I) the total number of deliveries available from the container. (2) the amount of actrve ingredients) released each time the valve is actuated The instruction leaflet includes (1) the direction for correct use of the aerosol, (2) a warning that the container may explode if punctured, exposed to excessive he at or direct sunlight; (3) the directions for the disposal of the used or partly-used container. STANDARDS Content of active ingredient delivered per spray" Apparatus - A small sample vessel suitable for shaking Tne size of the vessel is such that when the aerosol ts discharged into the specified volume of solvent under the conditions described in the Mettiod below, the discharge takes place not less than 25 mm below the surface of the solvent A stainless steel base plate with 3 legs and a central circular indentation with a hole about 1 5 mm in diameter is placed in me sample vessel The arrangement should prevent particle entrapment and side-of-stem leakage during the delivery of the sample Method - Remove the pressurised container from the actuator and remove all labels and markings which may be present on the container with a suitable solvent Dry the container, replace in its actuator, shake for about 30 seconds and holding it in an inverted position actuate trie valve by discharging about 5 sprays to waste Remove the pressurised container from its actuator, clean the valve stem (internally and extemally) and valve ferrule by washing with a suitable solvent. Dry the complete valve assembly using an airline fitted with an appropriate narrow jet to ensure that all solvent is removed from the inside of the valve stem Wash the actuator after the initial discharge of 5 sprays to waste, with a suitable solvent and allow it to dry Add to the sample vessel the volume of solvent specified in the monograph Shake the pressunsed container for about 30 seconds and place it inverted in the vessel Discharge 10 deliveries below the surface of trie solvent actuating the valve at intervals of not less than 5 seconds, maintaining the pressunsed container m the vertical plane and discharging the aerosol through the hole in the centre of the base plate With some preparations it may be necessary to shake the pressurised container between each actuation of the valve, in such cases shaking should be earned out without removing the pressunsed container from its inverted position in the vessel Remove the pressunsed container, wash it with the specified solvent and dilute the combined solution and washings to the volume specified in the monograph Determine the amount of active ingredient by the method descnbed under the Assay and calculate the amount discharged per actuation of valve (A) Fit the washed and dried actuator to the pressunsed container and actuate the valve 10 times at intervals of not less than 5 seconds Remove the actuator carefully from the pressunsed container and wash it with small quantities of the specified solvent Dilute the combined washings suitably and on the resulting solution determmine the amount of active ingredient as given in the Assay and calculate the amount of active ingredient per actuation of the valve (8) Calculate the content of active ingredient delivered per spray from the expression A-B Particle size. NOTE-Carry out the test in a laminar flow cabinet Filler all solvents through an appropriately sized filler before use Assemble a suitable membrane filtration apparatus. Use a filter holder fitted with an input chamber designed to prevent any loss of material when the actuator mouthpiece of the aerosol is inserted and the valve actuated Before assembly wash all parts of the membrane filter holder with water and rnethanot and dry in a stream of .nitrogen. Use a membrane filter with a nominal pore size not greater than 5 um and with the filtering surface free from foreign particles whenexarnmed microscopically using a magnification of not less than X40 Discharge 50 deirvenes from the pressunsed container into the orifice of the input chamber, actuating the valve at intervals of not less Than 5 seconds and washing down the particles deposited in the input chamber with successive 10-ml