Pharmaceutical Products

Specifications

Mannitol
1.Assay: 99% min
2.CAS NO: 69-65-8
3.Standard: BP2005/USP
4.Packaging: 25kg/bag


Mannitol,

1) Reference Standard: CP2000,USP24,BP2000
2) Quality Identification:
Item
CP2000
BP 2000
USP24
Appearance
White crystalline powder; odorless, sweet taste
White crystalline powder, soluble in water, slightly soluble in ethanol, non-soluble in aether
White crystalline powder, soluble in water, slightly soluble in ethanol, non-soluble in aether
Melting point
166 ~ 170
165 ~ 170
164 ~ 169
Identification
Pass on test
Pass on test
Pass on test
Acidity or Basicity
≤0.3ml of 0.02mol/L NaOH
≤0.3ml of 0.01mol/L HCL or≤0.2ml of 0.01mol/L NaOH
≤0.3ml of 0.02mol/L NaOH
Clarity and color of Solution
Clear and colorless
Clear and colorless

Chloride %
≤0.003
≤0.005
≤0.007
Sulphate %
≤0.010
≤0.010
≤0.01
Oxalate %
≤0.020


Residue on ignition %
≤0.1
≤0.1

Loss on drying %
≤0.5
≤0.5
≤0.3
Arsenic %
≤0.0002

≤0.0001
Heavy metals %
≤0.001
≤0. 00005

Nickle %

≤0.0001

Specific optical rotation

+23°+25°(in borax solution)
+137°+145° (in ammonium molybdate solution)
Reducing sugars


No more than few deposit
Assay %
98.0 ~ 102.0
98.0 ~ 101.5
96.0 ~ 101.5
Sorbitol %

≤2

Bacterial endotoxin

<100g/l of mannitol,≤4 I.U./g≥100g/l of mannitol,≤2.5 I.U./g