Sorbitol USP Grade

Applications

Sorbitol, also known as D-sorbitol, D-Glucitol or D-gluco hexanehexol, is a hexahydric sugar alcohol. Sorbitol is commercially manufactured by the high-pressure hydrogenation of dextrose solutions using a nickel catalyst. Sorbitol is a Lyophilic, non-toxic, non-irritant, stable and chemically inert, resistant to heat, resistant to acid and is non-fermentable by microorganisms. Sorbitol USP meets the requirements of the United States Pharmacopeia (USP) and has many uses. In medical application, Sorbitol can be used as a laxative. In food applications, Sorbitol is often used as a bulk sweetener and is about 60% as sweet as sucrose (table sugar). Sorbitol is also used in cosmetics as a thickener or humectant.

Sorbitol USP Grade, Liquid Form

WC Code: 19-043-01

Sales Specification

Description: Clear, colorless, syrupy liquid. Miscible with water
Identification (A. Presence of Sorbitol): A deep pink or wine red color appears
Identification (B. Examine the chromatogram Obtained in the Assay): The principal peak in the chromatogram obtained with test solution is similar in retention time to the principal peak in the chromatogram obtained with reference solution.
Identification (C. limit of diethylene glycol, ethylene glycol)
1) Diethylene Glycol:0.10 % Max
2) Ethylene Glycol):0.10 % Max
Appearance of Solution: Clear & colorless
Conductivity: 10.00 uScm-1 Max
pH (14.00 % Sol.): 5.0-7.5
Specific Gravity at 25® C: 1.280 g/ml Min
Reducing Sugars: N.L.T. 12.8, 0.5 ml N. Sodium Thiosulphate required
Reducing sugar after Hydrolysis: Not less than 8.0 ml of 0.05M, Sodium Thiosulphate Is required
Lead (Pb): 0.5 ppm Max
Nickel: Not more than 1.0 ppm
Additional test (Arsenic): Less than 2.0 ppm
Water content: 28.50 % – 31.50 %
Residue on ignition: 0.1 % Max
Specified pathogens: Should be absent
Content
Anhydrous substance: 68.00 % – 72.00 %
D-Sorbitol (100 % DS):72.00 % – 92.00 %
D-Sorbitol (as is): Not less than 45.00 %
Microbiology
Total Aerobic Microbial Count:1000 cfu/mL Max
Yeasts & Mould:100.000 cfu/ml Max

Quality Standard: USP 40

Packing

300 KG (661.38lb), 4 drums per pallet

Sorbitol USP Grade, Solid Form (55.12 Lbs)

WC Code: 19-043-03

Sales Specification

Appearance: White crystalline powder
Assay (HPLC): 91.0-100.5%
Odor: Odorless
Taste: Sweet
Indentification: Positive
Solubility: Soluble in water, slightly soluble in ethanol
pH: 3.5 – 7.0
Loss on Drying: ≤1%
Sulphated Ashes (on drying substance): ≤0.1%
Heavy Metal: ≤10ppm
Arsenic: ≤2ppm
Lead: ≤1mg/kg
Nickel: ≤1mg/kg
Total Sugars (as Glucose): ≤1%
Reducing Sugars (as Glucose): ≤0.3%
Total Bacteria Count: ≤100cfu/g
Molds & Yeasts: ≤10cfu/g
E.Coli: Absent/10g
Salmonella: Absent/25g
No organic solvents are used in the manufacturing of Sorbitol. Therefore, this Sorbitol meets all requirements as set forth in the current USP.
Conclusion: Comply with the current USP 30/FCCV requirements.