SPECIFICATION OF MAGNESIUM STEARATE IP
 
MAGNESIUM STEARATE
-IP
-BP
-USP
 Specification Sheet No.  NC/M/01
 Name of Product  Magnesium Stearate IP
 Code No.  MS-01
 Date of Preparation  01.02.03
 
 Sr. No.  Characteristics   Requirements
 1.  Description  White, unctus powder
 2.  Solubility  Insoluble in water
 3.  Identification  Gives test of Magnesium and stearates
 4.  Acid Value of Fatty Acids  Between 195 and 210 
 5.  Free Stearic Acid   Not more than 3 %
 6.  Heavy Metals  Not more than 20 PPM
 7.  Chloride   Not more than 0.1 %
 8.  Sulphate  Not more than 0.6 %
 9.  Loss on Drying  Not more than 6.0 % 
 10.  MgO   3.8 - 5 %
 11.  Bulk Density  0 .15 to 0.30 g/cc
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SPECIFICATION OF MAGNESIUM STEARATE BP

 
 Specification Sheet No.   NC/M/02
 Name of Product  Magnesium Stearate BP
 Code No.  MS-02        
 Date of Preparation  01.02.03
 
 Sr. No.  Characteristics   Requirements
 1.  Description  A white, very fine, light powder, greasy to the touch
 practically insoluble in water  & in ethanol    
 2.

 Identification

 A) Freezing point

 B)

 C)

 

 NLT 53 0 C

 To comply as per BP

 To comply as per BP
 3.  Acidity or Alkalinity  To comply as per BP
 4.  Chlorides  To comply as per BP
 5.  Sulphates  To comply as per BP
 6.  Cadmium   NMT 3 ppm
 7.  Lead  NMT 10 ppm
 8.  Nickle  NMT 5 ppm
 9.  Loss on Drying  NMT 6.0 %
 10.  Microbial Combination  To comply as per BP
 11.  Assay (Magnesium)  4 to 5 % of Mg
 12.  Fatty Acid Consumption  To comply as per BP
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SPECIFICATION OF MAGNESIUM STEARATE USP

   
 Specification Sheet No  NC/M/03
 Name of Product  Magnesium Stearate USP
 Code No.  MS-03
 Date of Preparation  01.02.03
 
 Sr. No.  Characteristics   Requirements
 1.  Description  As Per USP test
 2.  Identification

 A. Solution should respond to the test of Magnesium.

 B.The chromatogram of the Test Solution should 
 correspond to those. in Chromatogram of the System
 Suitability solution, as obtained in the Relative content of
 stearic Acid & palmitic acid test.

 3.  Acidity or Alkalinity  Not more than 0.05 mL of 0.1 N sodium hydroxide is 
 required to change the color of the indicator.
 4.  Loss on Drying  Should not lose more than 6.0 % of its weight
 5.  Specific Surface Area  Not claimed in the label
 6.  Chloride  Not more than 0.1 %
 7.  Sulfate   Not more than 1.0 %
 8.  Lead   Not more than 0.001 %
 9.  Organic Volatile Impurities  Should meet the requirements of Method IV of USP
 10.

 Relative content of Stearic
 acid & Palmitic acid by GLC
 content of Stearic acid(C18
 H36 O2) ANDSum of content
 of Stearic acid(C18 H36 O2)
 & Palmitic acid(C26 H32 O2)
 Relative Standard deviation for
 Six Injection in  GLC

 The stearate peak comprises not less than 40 %, and the
 sum of the Stearate and palmitate peaks is not less than
 90% of the total area of all fatty acid ester peaks in the 
 chromatogram. 

 1. For Palmitate
 2. For Stearate
 3. For ratio of Palmitate to 
 Stearate
 11.  Assay content of Magnesium 
 (Mg)		  Not less than 4.0 & not more than 5.0 % of Mg.
 12.  Related Substance  As Per USP Test
 13.

 Microbial Limit TestTotal
 Aerobic Microbial count (By
 Plate Count Method)
 (Incubated at 30 - 35 0 for 75
 hours)

 The total aerobic microbial count does not exceed 1000
 per g
   Total combined Yeast &
 Mould Count(By Plate Count
 Method)(Incubated at 20 - 25
 0 for 5 days)		  As Per USP test
   Test  for E. Col I  It should meets the requirements of the tests for absence of
 Escherichia coil
 14.  Bulk Density  0.2 – 0.3 g/cc
 15.  Fineness  95 % Passing through 200 Mesh
 16.  Melting Point  116 – 1210C
     
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