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                                                              1.16H DOSAGE FORMS OF HERBAL DRUGS
                                                                                       GRANULES
        Granules are preparations consisting of solid, dry aggregates of powder particles sufficiently resistant to withstand handling. They are intended for oral administration. Some are swallowed as such, some are chewed and some are dissolved or dispersed in water or another suitable liquid before being administered. Granules contain one or more active ingredients with or without added substances including, where necessary, authorized colouring matter and flavouring agents. Granules are presented as single-unit or multiple-unit preparations.  For single-unit preparations each dose is enclosed in an individual container, for example, a sachet, a paper packet or a vial. Each dose of a multiple-unit preparation is administered by means of a device suitable for measuring the quantity prescribed.
        Several categories of granules may be distinguished: (1) uncoated granules; (2) granules for the preparation for oral liquids (see under Oral Liquids); (3) coated granules; (4) modifiedrelease granules.
        Uniformity of dosage units  Unless otherwise prescribed in the individual monographs, granules comply with the “Uniformity of Dosage Units” (Appendix 4.28). The test for Content Uniformity is not required for multivitamin and trace element granules and herbal drug granules.
      Particle size  Topical granules and herbal drug granules comply with the following requirement. 
      Carry out the determination as described in the “Method for Determining the Particle Size” (Manual Sieving-Two Sieves, Appendix 1.11), use about 10 g of the granules, accurately weighed. Not more than 15 per cent of the granules examined pass through a sieve with a nominal mesh aperture of 180 μm and none passes through a sieve with a nominal mesh aperture of 2000 μm.
      Packaging and storage Unless otherwise specified the individual monograph. Granules shall be kept in tightly closed containers and stored in a dry place.
      Labelling For single-unit containers the label states the name(s) and amount(s) of active ingredient(s) per container and for multiple-unit containers the label states the name(s) and amount(s) of active ingredient(s) in a suitable quantity by weight.
                                                                                       POWDERS
       Powders are preparations consisting of solid, loose, dry particles of varying degrees of fineness that contain one or more active ingredients with or without added substances including, where necessary, flavouring agents and authorized colouring matter. Two categories of powders may be distinguished: (1) oral powders; (2) topical powders.
       Minimum fill  Powders comply with the test described in the “Minimum Fill” (Appendix 4.26).
       Uniformity of dosage units  Powders comply with the “Uniformity of Dosage Units” (Appendix 4.28). The test for Content Uniformity is not required for multivitamin and trace element powders and herbal drug powders.
      Particle size Topical powders and herbal drug powders comply with the following requirement.

      Carry out the determination as described in the “Method for Determining the Particle Size” (Manual Sieving-Single Sieve, Appendix 1.11), use about 10 g of the powder, accurately weighed. Not less than 95 per cent of the powder examined pass through a sieve with a nominal mesh aperture of 125 μm for chemical drugs and the sieve with a nominal mesh
aperture of 150 μm for herbal drugs.
       Packaging and storage  Powders should be kept in tightly closed containers.