Mannitol, D-



  • Product Code
  • Grade
  • Description
  • CAS
  • Formula
  • Formula Weight
  • UN
  • FlashPoint (°C)
  • Density (kg/L)
  • 2553
  • USP/EP/BP
  • White powder, multi-compendial grade
  • 69-65-8
  • HOCH2(CHOH)4CH2OH
  • 182.17
  •  
  •  
  •  


Code
Size
Price
01
500.00 G
CAD $ 109.00 Each
05
2.50 KG
CAD $ 278.00 Each
07
12.00 KG
CAD $    
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Product Specifications


Test Specification
GMP Manufactured Product  
Meets U.S.P. Requirements  
Assay (as HOCH2(CHOH)4CH2OH)
(calculated on anhydrous basis)		 96.0 - 101.5 %
Acidity Passes Test
Arsenic (As) max. 1 ppm
Chloride (Cl) max. 0.007 %
Identification Passes Test
Loss on Drying at 105°C max. 0.3 %
Melting Range 164 - 169 °C.
Reducing Sugars Passes Test
Specific Rotation [a]25D 137 - 145 °
Sulfate (SO4) max. 0.01 %
   
Meets BP/Ph.Eur. Chemical Specifications  
Assay (as HOCH2(CHOH)4CH2OH)
(calculated on anhydrous basis)		 98.0 - 102.0 %
Identification A Passes Test
Identification B Passes Test
Identification C Passes Test
Identification D Passes Test
Appearance of Solution Passes Test
Conductivity, uS cm-1 max. 20
Reducing Sugars max. 0.2 %
Related Substances  
Impurities A,B,C max. 2.0 %
Any other Impurity max. 0.1 %
Total max. 2.0 %
Lead (Pb) max. 0.5 ppm
Nickel (Ni) max. 1 ppm
Water (H2O) max. 0.5 %
Endotoxin Concentration, <2.5 IU/g Passes Test
Total Viable Aerobic Count (cfu):  
Bacterial Count (per g) max. 100
Fungi Count (per g) max. 100
Eschericha coli and Salmonella Passes Test
   
Meets JP Chemical Specifications  
Assay (HOCH2(CHOH)4CH2OH) (dried basis) 98.0 - 101.0 %
Identification A Passes Test
Identification B Passes Test
Specific Rotation [a]20D 137 - 145 °
Melting Point 166 - 169 °C.
Clarity and Color Passes Test
Acidity Passes Test
Chloride (Cl) max. 0.007 %
Sulfate (SO4) max. 0.010 %
Heavy Metals (as Pb) max. 5 ppm
Nickel (Ni) Passes Test
Arsenic (As) max. 1.3 ppm
Sugars Passes Test
Loss on Drying at 105°C max. 0.30 %
Residue on Ignition max. 0.10 %
   
Suitable for use in the manufacture of parenteral dosage forms.  
   
No Class 1,2, or 3 solvents are used in production or purification and are not present in the final product.  
Bulk Pharmaceutical Chemical  
CAUTION: For manufacturing, processing or repacking.