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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Please make cheques and money orders payable to ANK Pharmaceuticals Inc. (Sister company for web orders)

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* We only ship within Canada. We do not ship to the United States or anywhere else worldwide.

All sales are final. Please confirm desired grade before ordering.

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.