Lactitol Anhydrous Monohydrate Dihydrate BP Ph Eur USP NF Grade Manufacturers Exporters |
| Aadhunik Industries is a manufacturing group company. Aadhunik Industries is pioneer manufacturers of Lactitol Anhydrous Monohydrate Dihydrate, Specialty Chemicals, Pharmaceutical Excipients, Food Fragrance & Flavor chemicals in India. It has toll manufacturers and representatives in UAE, Europe, Canada & USA and agents & customers in all countries like USA, Canada, Europe, UAE, South Africa, Tanzania, Kenya, Egypt, Nigeria, Uganda, Turkey, Mexico, Brazil, Chile, Argentina, Dubai, Netherlands, Italy, Spain, Germany, Portugal, France, Malaysia, Indonesia, Thailand, Korea, Japan, Russia etc. |
| Aadhunik Industries and/or associated units are FDA-GMP certified, Halal and/or Kosher certified, REACH registered, ISO-9001, ISO-22000 HACCP certified. We offer crystals granules in precise micron or mesh size as per buyers needs. We offer very high purity standards as per specifications required. |
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SDS MSDS of Lactitol Anhydrous Monohydrate Dihydrate BP Ph Eur USP NF Grade Manufacturers
Specifications of Lactitol Anhydrous Monohydrate Dihydrate BP Ph Eur Grade Show/Hide Details
Lactitol Monohydrate BP Ph Eur Grade Specifications
Ph. Eur.
C12H24O11-H2O --- 362.3 --- CAS 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.
Specifications of Lactitol Anhydrous Monohydrate Dihydrate USP NF Grade Show/Hide Details
Lactitol USP NF Grade Specifications
C12H24O11 --- 344.31
4-O- -D-Galactopyranosyl-D-glucitol --- CAS 585-86-4
Monohydrate 362.34 CAS 81025-04-9
Dihydrate 380.35 CAS 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.
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%.
CAS Number 81025-04-9 (Monohydrate), 81025-03-8 (Dihydrate) and 585-86-4 (Anhydrous), Lactitol Anhydrous Monohydrate Dihydrate BP Ph Eur USP NF Grade manufacturers suppliers exporters at:
manufacturer supplier exporter
Aadhunik Industries
Ankleshwar Gujarat & Mumbai, India
TEL: (OFFICE) 91-22-23774610, 23723564.
e-mail: info@aadhunikindustries.com
Copyright and Usual Disclaimer is Applicable. 7-12-2022
Acetic Acid Glacial ------- Ammonium Bicarbonate ------- Aluminum Chloride ------- Aluminium Potassium Sulphate ------- Ammonium Carbonate ------- Ammonium Carbamate ------- Ammonium Chloride ------- Ammonium Persulfate------- Barium Chloride ------- Benzyl Alcohol ------- Benzoic Acid ------- Boric Acid ------- Borax ------- Calcium Chloride ------- Calcium Oxide ------- Calcium Hydroxide ------- Calcium Lactobionate ------- Calcium D Saccharate ------- Calcium Sulfate ------- Carbamide Peroxide ------- Chromic Chloride -------Copper Cupric Chloride ------- Copper Sulphate ------- Precipitated Coated & Directly Compressible Calcium Carbonate ------- Fumaric Acid ------- Ferric Chloride ------- Formaldehyde Solution ------- Lithium Carbonate ------- Magnesium Chloride ------- Magnesium Sulphate ------- Maleic Acid ------- Malic Acid ------- Manganese Chloride ------- Manganese Sulphate ------- Octyl Dodecanol ------- Oleic Acid ------- Phenyl Ethanol ------- Potassium Bromide ------- Potassium Chloride ------- Potassium Hydroxide Pellets ------- Potassium Monopersulfate ------- Potassium Phosphate Monobasic Dibasic Tribasic ------- Propylene Carbonate ------- Selenious Acid ------- Sodium Acetate ------- Sodium Diacetate ------- Sodium Hydroxide Pellets------- Sodium Thiosulfate ------- Sodium Formaldehyde Bisulfite ------- Sodium Perborate ------- Vanadyl Sulfate ------- Zinc Chloride