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Lactitol USP NF BP Manufacturers

Anmol Chemicals Group, established in 1976, is the pioneer manufacturer of Specialty chemicals, Pharmaceutical Excipients, Fragrance & Flavor chemicals in India. Anmol Chemicals Group has manufacturing facilities spread across Western India, representatives in Houston Chicago USA and toll manufacturers in China. We also have toll manufacturing units for processing chemicals in a few countries around the world. We make IP, BP, USP, Ph. Eur., FCC or Food Grade, ACS, AR or Analytical Reagent Grade, LR or Laboratory Reagent Grade, Pure and Technical Grades of various chemicals. All our items are analyzed to meet the required standards.

Our manufacturing facility is FDA approved and GMP, ISO-9001-2008, ISO-14001, ISO OHSAS 18000, ISO 22000-2005 HACCP, FSSAI, FSSC-22000, certified. We are offering products manufactured as per Kosher and Halal approved certified method. We are pre-registered with "Reach" for export to European countries. We can give all solid chemical materials as per specified size or shape.

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Lactitol SDS of Manufacturers

Lactitol Manufacturers

Synonyms: 4-O-β-D-Galactopyranosyl-D-glucitol
CAS Number: 81025-04-9 (Monohydrate), 81025-03-8 (Dihydrate) and 585-86-4 (Anhydrous), Molecular Weight: 362.3 or 380.35 or 344.31, Chemical Formula: C12H24O11-H2O or C12H24O11-2H2O or C12H24O11, EINECS EC Number: 209-566-5, FEMA: ----,

Lactitol is a sugar alcohol used as a replacement bulk sweetener for low calorie foods with approximately 40% of the sweetness of sugar. It is also used medically as a laxative.

Lactitol Monohydrate BP
Ph. Eur.
C12H24O11-H2O --- 362.3 --- 81025-04-9
Action and use: Osmotic laxative.

DEFINITION
4-O-β-D-Galactopyranosyl-D-glucitol monohydrate.
Content: 96.5 per cent to 102.0 per cent (anhydrous substance).

CHARACTERS
Appearance: White or almost white, crystalline powder.
Solubility: Very soluble in water, slightly soluble in ethanol (96 per cent), practically insoluble in methylene chloride

IDENTIFICATION
First identification: B
Second identification: A, C
A. Specific optical rotation (see Tests).
B. Infrared absorption spectrophotometry.
C. Thin-layer chromatography.

TESTS
Solution S: Dissolve 5.000 g in carbon dioxide-free water and dilute to 50.0 mL with the same solvent.
Appearance of solution: Solution S is clear and not more intensely coloured than reference solution.
Acidity or alkalinity: To 10 mL of solution S add 10 mL of carbon dioxide-free water R. To 10 mL of this solution add 0.05 mL of phenolphthalein solution. Not more than 0.2 mL of 0.01 M sodium hydroxide is required to change the colour of the indicator to pink. To a further 10 mL of the solution add 0.05 mL of methyl red solution. Not more than 0.3 mL of 0.01 M hydrochloric acid is required to change the colour of the indicator to red.
Specific optical rotation: + 13.5 to + 15.5 (anhydrous substance), determined on solution S.
Related substances: To pass the test.
Reducing sugars: Maximum 0.2 per cent.
Lead: Maximum 0.5 ppm.
Nickel: Maximum 1 ppm.
Water: 4.5 per cent to 5.5 per cent, determined on 0.30 g.
Sulfated ash: Maximum 0.1 per cent, determined on 1.0 g.
Microbial contamination:
TAMC: acceptance criterion 103 CFU/g.
TYMC: acceptance criterion 102 CFU/g.
Absence of Escherichia coli.
Absence of Salmonella.
Absence of Pseudomonas aeruginosa.
IMPURITIES
A. 4-O-β-D-galactopyranosyl-D-glucopyranose (lactose),
B. 3-O-β-D-galactopyranosyl-D-glucitol (lactulitol),
C. D-mannitol,
D. galactitol (dulcitol),
E. D-glucitol (D-sorbitol).


Lactitol USP NF
C12H24O11 --- 344.31
4-O- -D-Galactopyranosyl-D-glucitol --- [585-86-4].
Monohydrate. 362.34 [81025-04-9].
Dihydrate. 380.35 [81025-03-8].
Lactitol contains not less than 98.0 percent and not more than 101.0 percent of C12H24O11, calculated on the anhydrous basis.

Packaging and storage: Preserve in well-closed containers.
Labeling: Label it to indicate whether it is the monohydrate, the dihydrate, or the anhydrous form.
Identification, Infrared Absorption.
Water: between 4.5% and 5.5% (monohydrate); between 9.5% and 10.5% (dihydrate); and not more than 0.5% for the anhydrous form.
Residue on ignition: not more than 0.5%.
Heavy metals: Dissolve 4 g of it in 25 mL of water: the limit is 5 microgm per gm.
Reducing sugars: To pass the test. (0.2%, as dextrose).
Related compounds: To pass the test. The total of the percentages of all related compounds is not more than 1.5%.

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Manufacturers

ANMOL CHEMICALS
Taloja Mumbai and Ankleshwar Gujarat, INDIA
Representatives in Houston, Chicago and New York, USA
TEL: (OFF) 91-22-23726950, 23774610, 23723564

e-mail: info@anmol.org

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Last updated 26-sep-18

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Lactitol
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Lactitol