| Anmol Chemicals is the pioneer manufacturers of Lactitol Monohydrate Dihydrate, Pharmaceutical Excipients Food & Flavor chemicals in India. We supply Halal and Kosher Lactitol Monohydrate Dihydrate made in an ISO9001, ISO22000 (FSSC22000) cGMP and GLP certified facility. Our group has several manufacturing facilities spread across the world, supported by toll manufacturers and representatives in UAE, Europe, Africa, USA, China and has several associated manufacturing facilities spread across India. All the Information on Physics, Chemistry, Applications, Uses and Technology on Manufacture of Lactitol Monohydrate Dihydrate is in these pages. |
| The units have one or more of the certifications like FDA GMP, ISO 9001, ISO 22000, HACCP, REACH, Kosher & Halal |
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Lactitol Monohydrate Dihydrate BP Ph Eur Grade Manufacturers
Lactitol SDS MSDS Sheet of Manufacturers
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 1000 CFU/g.
TYMC: acceptance criterion 1002 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).
Manufacturers
Anmol Chemicals
S-8, SARIFA MANSION, 2ND FLANK ROAD, CHINCHBUNDER, MUMBAI 400009, INDIA
TEL: (OFFICE) 91-22-23770100, 23726950, 23774610, 23723564. FAX: 91-22-23728264
e-mail: anmolc@mtnl.net.in
Copyright and Usual Disclaimer is Applicable. 20 January, 2022
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