Table 1 : Quality target product profile.


Tests Test methods Specifications

Tablet Assay High Performance Liquid Chromatography
USP <621>
90–110%

Tablet Moisture Moisture Analyzer
(Metler Toledo’s Operating Manual)
≤6%

Tablet Hardness Hardness Tester
USP <1217>
Average: [3.5-7.0] Kp,
Individuals: [3.0-8.0] Kp

Tablet Friability Friability Tester
USP <1216>
≤1%

Tablet Disintegration
Time
Disintegration Tester
USP <701>
≤45 min.

Tablet Appearance Visual Round Brown Biconvex
Average Tablet Weight Analytical Balance 289.4 mg±5%

Maltais et al.Journal of Pharmaceutical Technology and Drug Research  2015 4:2DOI : 10.7243/2050-120X-4-2