Quality assessment of nine paracetamol 500 mg tablet brands marketed in Saudi Arabia

BMC Research Notes

Table 1 In-vitro quality of two reference and seven generic paracetamol 500 mg tablet brands available on the Saudi market

Code	Weight n = 20		Active substance content^b n = 20		Breaking force n = 10	Friability n = 20	Disintegration^d n = 6	Dissolution^e n = 8
	Mean (SD), mg	Range^a, % from mean	Mean (SD), mg	Mean (SD), % of label	Mean (SD), kg	% loss	Range minute: second	Mean (range) release at 30 min, % of label
R1	599.6 (4.1)	99–101	480.4 (14.6)	96.1 (2.9)	15.4 (0.7)	0.017	04:21–04:58	97 (96–98)
G1	569.4 (4.3)	98–102	497.8 (12.3)	99.6 (2.5)	16.3 (1.5)	0.625	02:35–03:09	91 (88–93)
G2	560.6 (4.3)	99–101	489.9 (12.8)	98.0 (2.6)	18.8 (1.2)	0.809	04:23–04:56	95 (92–97)
G3	553.2 (3.3)	99–101	485.9 (4.9)	97.2 (1.0)	13.1 (0.9)	0.378	04:42–05:35	97 (94–100)
R2	688.4 (5.8)	99–101	498.9 (5.7)	99.8 (1.1)	14.9 (0.9)	0.366	05:16–07:51	95 (94–97)
G4	744.1 (5.7)	99–101	488.6 (6.0)	97.7 (1.2)	9.9 (0.4)	0.717	10.39–10.59	87 (80–96)^f
G5	560.6 (4.3)	99–101	497.5 (4.2)	99.5 (0.8)	18.3 (1.7)	0.351	8:43–9:30	96 (91–99)
G6	797.3 (4.5)	99–101	498.0 (5.4)	99.6 (1.1)	15.3 (1.5)	0.526	9:02–10:13	96 (94–98)
G7	838.1 (10.5)	97–102	498.1 (4.6)	99.6 (0.9)	21.0 (0.9)	0.167	12:49–13:10	96 (82–100)^f

^aAcceptable variation limits, ≤ ± 5% (for tablets ≥ 250 mg). ^bAcceptable limits, mean content 90–110% of label. ^cAcceptable limit, ≤ 1%. ^dWater medium, acceptable limit, ≤ 15 min. ^ePhosphate buffer (pH 5.8) medium, acceptable limit, ≥ 80 + 5% of label. ^fMean (range) of 12 rather than 8 units

ISSN: 1756-0500