Specifications and properties*

Appearance Free-flowing, non-fibrous powder
Color White
Identification A Conforms
Identification B (Degree of Polymerization) NMT 350
Conductivity < 75 μs/cm
pH 5.0 to 7.5
Loss on drying < 7.0%
Residue on ignition < 0.10%
Water-soluble substances < 0.25%
Ether-soluble substances < 0.05%
Heavy metals < 10 ppm
Organic volatile impurities Within limits
Microbial limits
　　Total aerobic microbial (counts/g) < 100
　　Total molds & yeasts (counts/g) < 10
　　S. aureus (/10g) Absence
　　P. aeruginosa (/10g) Absence
　　E. coli (/10g) Absence
　　Salmonella species (/10g) Absence

Microbial limits
   Total aerobic microbial (counts/g) < 100
   Total molds & yeasts (counts/g) < 10
   S. aureus: Absence
   P. aeruginosa: Absence
   E. coli: Absence
   Salmonella species: Absence

* conforms to USP/NF, EP, BP, JP specifications.



Standard grades available and their typical properties *
Particle Size (μ)

Grade D10 D50 D90 Moisture % Bulk Density DP
M101 < 30 40 - 60 > 80 3.0 - 5.0 0.26 - 0.34 210 - 270
M102 < 45 70 - 100 > 140 3.0 - 5.0 0.28 - 0.35 210 - 270 
M103 < 30 40 - 60 > 80 1.0 - 3.0 0.26 - 0.34 210 - 270 
M105 ** ** ** 1.0 - 5.0 0.20 - 0.30 210 - 270 
M112 < 45 70 - 100 > 140 0.0 - 1.5 0.28 - 0.37 210 - 270
M113 < 30 40 - 60 > 80 0.0 - 2.0 0.26 - 0.34 210 - 270
M200 < 70 140 - 200 > 260 3.0 - 5.0 0.32 - 0.42 210 - 270
M212 < 60 100 - 160 > 200 3.0 - 3.5 0.30 - 0.36 210 - 270 
M301 < 30 40 - 60 > 80 3.0 - 5.0 0.34 - 0.45 150 - 210
M302 < 45 70 - 100 > 140 3.0 - 5.0 0.35 - 0.46 150 - 210 


* M101: Most widely used for direct compression and wet granulation.
* M102: Similar in use to 101; however, has larger particle size and better flowability
* M105: Finest particle size available
* M103, 112, 113: Low moisture products in the series; ideal for use with moisture sensitive ingredients.
* M200: Coarsest particle size available for direct compression applications.

* M212: Optimal choice for obtaining both good flowability and compressibility.
* M301, M302: High density version equivalent to the 101 and 102, respectively, with improved flowability.


** The Ro Tap method is not appropriate for determining particle size distribution of M105

** The particle size of M212 is 425μ retained not more than 1%,

     160μ retained not more than 50%, 50μ retained not less than 70% .

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