usr 40 Genera information / (1216) Tablet Friabilty 1749 offers no nondestructive altematives for ascertaining the microbiological quality of every fished article inthe lot, ond itis not Seale pion to increase the numberof specimens significantly, For information regarding the conduct of the tei test please see Sent Tests 71) (1216) TABLET FRIABILITY ‘This general information chapter has been harmonized with the cortesponcing texts ofthe European Pharmacopoeia and the Japanese Pharmacopoeia, The harmonized texts of these three pharmacopeias are therefore interchangeable, and the methods tf the Eurapeon Pharmacopoeia andlor the japanese Pharmacopoeia may be used for demonstration of compllance instead of the present Unted States Phammacopeta general information chapter metnod. These pharmacopeas have undertaken not to ‘make any unlateral change to this harmonized chapter, “This chapter provides guidelines forthe frailty determination of compressed, uncoated tablets. The test procedure presen tedin ths chapters generally applicable to most comprested tablets. Measurement of tablet frability supplements other physical strength measurements, suchas tablet breaking free. ‘Use a drum," with an internal ameter between 283 and 291 ram and a depth between 36 and 40 mm, of transparent synthetic polymer with polished interna surfaces, and subject to minimum static buldp (see figure fora typical apparatus), ‘One side Of the drum is removable, The tablets are tumbled at each tun of the crum by a curved projection with an inside rads between 75.5 and 85.5 mm that extends from the mile of the drum to the outer wall. The outer diameter ofthe ‘Central ring between 24.5 and 25.5 mm. The drum is attached to the horizontal axis ofa device tat rotates at 25 £1 pm “Thus, at cach tun the tablets roll or se and fal onto the drum wall or onto each other. eat “able ily Apparatus f hoe bles conesponding a nes ptsbie aiea : Onde eles Te ues shoud Beco 1 Sted poo ering Aci meh abet leh ables he un Rte the en 108 tens = Sea es ee eer Teo apeae a broken tablets are present Inthe tablet sample aftr tum bana the comple fas the test I the results bre fic to interpret or the weight fos s greater than the targeted value, the ea ees eae aN Terre PoE aC ACPRRTEA Tr oes od bas erste ae ‘ples of not mare than 1.0% is considered acceptable for most products, abt co hape caves rogr tmbi, so Ive rum bas tat th ba forms an angle fsbo 10° wih the potuanl andthe abies no lnge bye when ing nest ouch ther, ch preertsthe em alg ee: cua aicson cee lets ty have et apeeston ao aby concrete eave 9 cram abe co sppreptehamiatyconvoled emionet aque eg. ra mt alee projectons oan operts wih mere tan one drm fr tering of mull samples oe opera! ‘The porns neigh pcarsey ply ouch Vo Tedeny eu, 1000 xo Patna, NE {518 ara tease ny 56 Gus oa, los, C1 948