Parameters

Brand ALT1

Brand

AMT2

Brand AMT3

Brand

AST4

Standard

Specifications

Remarks

Description &

Packaging

Round, white,

Alu Alu

Octahedral,

White,

Alu PVC

Round,

White,

Alu PVC

Round,

Orange,

Alu PVC

-

-

Average

Weight (mg)

Mean ± SD

70.15 ±

1.22

137.28 ± 2.20

160.23 ± 3.74

168.25 ± 4.91

Weight

Variation (%)

(−) 2.21 to (+) 3.78

(−) 3.56 to (+) 1.83

(−) 3.82 to (+) 5.47

(−) 7.34 to (+) 5.02

± 10% (≤ 130 mg)

± 7.5% (130 - 324 mg).

Comply

Hardness

Test (kg)

Mean ± SD

3.60 ± 0.48

9.52 ± 1.85

2.29 ± 0.15

3.12 ± 0.72

Friability

Test (%)

0.007

0.08

0.02

0.006

0.5% to 1%

Comply

Thickness

Test (%)

(−) 1.12 to (+) 1.80

(−) 2.76 to (+) 2.34

(−) 4.57 to (+) 2.92

(−) 0.99 to (+) 0.94

± 5%

Comply

Loss on Drying

4.45%

4.75%

6.17%

5.27%

Disintegration

Time

23 sec

36 sec

3 min 3 sec

2 min 43 sec

Within 30 minutes

Comply

% Dissolved in 30 min.

95.34%

92.33%

84.29%

92.49%

Minimum 75%

in 30 min

Comply

Assay (%) ± SD

105.15 ± 0.34

104.15 ± 0.22

103.89 ± 1.05

105.53 ± 1.77

90% − 110%

Comply