Identifications

Crystalline Sorbitol Standard

Parenteral Sorbitol Standard

CP2000

USP24

BP2000

Appearance

White crystalline powder, odorless, sweet taste

White crystalline powder, odorless, sweet taste

White crystalline powder, soluble in water,slightly soluble in Enthanol, insoluble in Aether.

Refractive index

4.0° 7.0°

4.0° 7.0°

4.0° 7.0°

Inspection result

Pass on test

Pass on test

Pass on test

Pass on test

Acidity or Alkalinity

≤0.3ml of 0.02 mol/L NaOH

≤0.3ml of 0.02 mol/L NaOH

≤0.3ml of 0.02 mol/L NaOH

≤0.3ml of 0.01mol/L HCL or≤0.2ml of 0.01mol/LNaOH

Clarity and color of solution

Clear and colorless

Clear and colorless

Clear and colorless

Clear and colorless

Chloride %

≤0.0050

≤0.0050

≤0.0050

≤0.005

Sulphate %

≤0.010

≤0.010

≤0.010

≤0.010

Reducing sugar mg

≤50

≤67

≤50

≤50

Total glucose assay mg

≤50

≤50

≤50

≤50

Loss on drying or water %

≤1.0

≤1.0

≤1.0

≤1.5

Residue on ignition %

≤0.1

≤0.1

≤0.1

≤0.1

Heavy metals (Pb) %

≤0.0001

≤0.0010

≤0.001

≤0.00005

Arsenic %

≤0.0001

≤0.0002

≤0.0003

98.0101.0

Assay %

≥95.0

≥98.0

91.0100.5

≤0.0001

Nickle %

≤0.0002

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

Bacterial Endotoxin

Note

Granularity: according to requirement