Disintegration Time:- Uncoated Tablet NMT 15 min, in water with Disc 37 0 C ± 2 0 C Coated Tablet NMT 30 min, In water with Disc for Film Coated Tab , and NMT 60 min Other than Film coated tablet Enteric Coated Tab Intact for 2 hr in 0.1 N HCl & disintegrate within 1 hr in Mixed 6.8 Phosphate buffer. According to USP 2 hr in Simulated gastric fluid, then in Simulated Intestinal Fluid. Dispersible/Soluble Within 3 min in water at 25 0 C ± 1 0 C ( IP ) & 15 – 25 0 C ( BP ) Orodispersible Within 1 min Effervescent Tab 5 min in 250 ml water at 20 – 30 0 C ( IP ) & 5 min in 200 ml water at 15-25 0 C ( BP ) Buccal & Sublingual Not Applicable but dissolve within 15 – 30 min. DT Apparatus:- Mesh Apperture:- 2mm (#10), Cycles:- 28 – 32 cycles/min, 50 – 60 mm distance from bottom & top, Temp of water 37 0 C ± 2 0 C. If 1 or 2 tabs fail, repeat for 12 tabs. Click to Buy Here
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