สารบัญ

Powders

          The degree of coarseness or fineness of a powder is diffentiated and expressed by reference to the nominal mesh aperture size of the sieves used.

          The following terms are used in the description of powders:

          COARSE POWDER A powder all the particles of which pass through a sieve with a nominal mesh aperture of 1.70 mm and not more than 40.0 per cent through a sieve with a nominal mesh aperture of 355 μm.

          MODERATELY COARSE POWDER A powder all the particles of which pass through a sieve with a nominal mesh aperture of 710 μm and not more than 40.0 per cent through a sieve with a nominal mesh aperture of 250 μm.

          MODERATELY FINE POWDER A powder all the particles of which pass through a sieve with a nominal mesh aperture of 355 μm and not more than 40.0 per cent through a sieve with a nominal mesh aperture of 180 μm.

          FINE POWDER A powder all the particles of which pass through a sieve with a nominal mesh aperture of 180 μm.

          VERY FINE POWDER A powder all the particles of which pass through a sieve with a nominal mesh aperture of 125 μm.

          When the fineness of a powder is described by means of number, it is intended that all the particles of the powder shall pass through a sieve of which the nominal mesh aperture, in μm, is equal to that number.

          When a batch of a vegetable drug is being ground and sifted, no portion of the drug shall be rejected, but it is permissible, except in the case of assays, to withhold the final tailings, if an approximately equal amount of tailings from a preceding batch of the same drug has been added before grinding.

          When the use of sieves is inappropriate, the definition is expressed in terms of the particle size as determined by suitable microscopical examination.

Sieves

          Wire mesh sieves used in sifting powdered drugs are identified by numbers indicating the nominal mesh aperture.

          The sieves should be made of wires of uniform circular cross-section. The wires may be of stainless steel or of other suitable material except that plated wire is not permitted. Sieves should confrom to the specifications which are concordant with the recomended International standard ISO 3310-1:2000 (E), shown in the following table.

          Calibration and recalibration of tes t sieves is in accordance with the mos t current edition of ISO 3310-1. Sieves should be carefully examined for gross distortions and fractures, especially at their screen frame joints, before use. Sieves may be calibrated optically to es timate the average opening size, and opening variability, of the sieve mesh. Alternatively, for the evaluation of the effective opening of test sieves in the size range of 212 to 850 μm, Standard Glass Spheres are available from the national or international organization, e.g. NIST¹. Unless otherwise specified in the individual monograph, perform the sieve analysis at controlled room temperature and a relative humidity between 20 and 70 per cent.

¹US National Ins titute of Standards and Technology.

          CLEANING TEST SIEVES Ideally, test sieves should be cleaned using only an air jet or a liquid s tream. If some apertures remain blocked by test particles, careful gentle brushing may be used as a last resort. Washing sieves in hot water is not recommended since the sieves can dis tort and rupture during heating and cooling. If it is necessary to use water, it should be used at ambient temperature and the sieve dried by first using a volatile watermiscible solvent to remove the water and then a low-pressure air jet to remove the solvent. This procedure should be carried out in a fume hood or cabinet that conforms to local regulations.

Method for Determining Powder Fineness

          Place the specified quantity of the test powder upon the appropriate sieve having a close- fitting receiving pan and cover. Shake the sieve in a rotary horizontal direction and vertically by tapping on a hard surface for not less than the specified time or until sifting is practically complete. Avoid prolonged shaking that would result in increasing the fineness of the powder during the testing. In the case of oily or other powders that tend to clog the openings, carefully brush the screen at intervals during the test. Breaking up lumps that form during the sifting. Weigh accurately the amount remaining on the sieve and in the receiving pan.

          The fineness of a powdered drug or chemical may be determined also by screening through the sieves in mechanical sieve shaker, which reproduces the circular and tapping motion given to tes ting sieves in hand sifting but with a uniform mechanical action, following the directions provided by the manufacturer of the shaker.