Certificate of Analysis of Magnesium Stearate |
Test |
Result |
Remarks |
Characterstics of Magnesium Stearate |
A white very fine, light powder, greasy to touch, practically Insoluble in water and in ethanol. |
Complies |
A) Freezing point (2.2.18) 53.2°C (Limits : Min.53°C) |
Complies |
B) The acid value of the fatty acids (2.5.1) 201 (Limits 195 to 201) |
Complies |
C)Chromatograms in the test for fatty acid. The retention time of the principal peaks of the test and reference solution are approximately same. |
Complies |
D) 1 ml of solution S (see tests) gives the reaction of magnesium (2.3.1) |
Complies |
E) Acidity or Alkality 0.03 ml of 0.1 M HCI Solutions (Limits : Mac 0.05 ml of 0.1 M HCI or 0.01 M NaOH solution) |
Complies |
Chlorides (2.4.4) |
0.06 % (Limits 0.1%) |
Complies |
Sulphates (2.4.13) |
0.4 % (Limits : Max 0.5%) |
Complies |
Heavy Metals |
NIL ppm (Limits : N.M.T.20ppm) |
Complies |
Loss on Drying |
4.38 (Limits : Max : 6%) |
Complies |
At 100 to 105°C (2.2.3.2) |
Microbial contamination (2.6.12) |
Total viable aerobic count |
PASSES (limits : Not more than 103 bacteria per gm) |
Complies |
Fungi |
PASSES (Limits : Not more than 102 fungi per gm) |
Complies |
Escherichia coli (2.6.13) |
ABSENT (Limits : Absent) |
Complies |
Assay |
4.39% (limits : 4.0 to 5.0 % of mg) |
Complies |
Fatty Acid |
Examine by gas chromatography |
Complies |