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Directly Compressible Lactose Monohydrate & Lactose Monohydrate Anhydrous Analytical Reagent USP NF Grade Supplier Exporter Manufacturers' Representative |
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Directly Compressible Lactose Monohydrate n Lactose Monohydrate Anhydrous USP NF
CAS Number: 63-42-3 for Anhydrous and 64044-51-5 for Monohydrate
Molecular Formula: C12H22O11 Anhydrous
Molecular Weight: 342.30 Anhydrous
Directly Compressible Lactose Monohydrate n Lactose Monohydrate Anhydrous
Specifications of Lactose Monohydrate USP NF Grade:
Lactose Monohydrate is a natural disaccharide, obtained from milk, which consists of one glucose and one galactose moiety. [NOTE—Lactose Monohydrate may be modified as to its physical characteristics. It may contain varying proportions of amorphous lactose.]
Clarity and color of solution: A solution of 1 g in 10 mL of boiling water is clear and nearly colorless. Determine the absorbance of this solution at a wavelength of 400 nm. The absorbance divided by the path length in centimeters is not more than 0.04.
Identification:
A: Infrared Absorption.
B: To pass the chromatographic test.
C: Dissolve 250 mg in 5 mL of water. Add 3 mL of ammonium hydroxide, and heat in a water bath at 80C for 10 minutes: a red color develops.
Specific rotation: Dissolve 10 g by heating in 80 mL of water to 50 . Allow to cool, and add 0.2 mL of 6 N ammonium hydroxide. Allow to stand for 30 minutes, and dilute with water to 100 mL: the specific rotation, calculated on the anhydrous basis, determined at 20C, is between +54.4 and +55.9.
Microbial limits: The total aerobic microbial count does not exceed 100 cfu per g, the total combined molds and yeasts count does not exceed 50 cfu per g, and it meets the requirements of the test for absence of Escherichia coli.
Acidity or alkalinity: Dissolve 6 g by heating in 25 mL of carbon dioxide-free water, cool, and add 0.3 mL of phenolphthalein: the solution is colorless, and not more than 0.4 mL of 0.1 N sodium hydroxide is required to produce a red color.
Loss on drying: Dry it at 80 for 2 hours: the monohydrate form loses not more than 0.5% of its weight, and the modified monohydrate form loses not more than 1.0% of its weight.
Water: between 4.5% and 5.5%, determined on a preparation containing lactose monohydrate in a mixture of methanol and formamide (2:1).
Residue on ignition: not more than 0.1%, determined on a specimen ignited at a temperature of 600C± 25C.
Heavy metals: Dissolve 4 g in 20 mL of warm water, add 1 mL of 0.1 N hydrochloric acid, and dilute with water to 25 mL: the limit is 5 Micro-g per g.
Protein and light-absorbing impurities: Measure the light absorption of a 1% (w/v) solution in the range of 210 to 300 nm. The absorbance divided by the path length in centimeters is not more than 0.25 in the range of 210 to 220 nm and is not more than 0.07 in the range of 270 to 300 nm.
Specifications of Anhydrous Lactose USP NF Grade:
DEFINITION
Anhydrous Lactose is O-β-d-galactopyranosyl-(1→4)-β-d-glucopyranose (β-lactose), or a mixture of O-β-d-galactopyranosyl-(1→4)-β-d-glucopyranose and O-β-d-galactopyranosyl-(1→4)-α-d-glucopyranose (α-lactose).
IDENTIFICATION
A. Infrared Absorption
B. Thin-Layer Chromatographic Identification Test: To pass the test.
Content of Alpha and Beta Anomers: To pass the test.
Residue on Ignition: NMT 0.1%
Clarity and Color of Solution: To pass the test.
Loss on Drying:
Analysis: Dry a sample at 80C for 2 h.
Acceptance criteria: NMT 0.5%
Water Determination: To pass the test.
Acceptance criteria: NMT 1.0%
Microbial Enumeration Tests and Tests for Specified Microorganisms: The total aerobic microbial count is NMT 100 cfu/g and the total combined molds and yeasts count is NMT 50 cfu/g. It meets the requirements of the test for absence of Escherichia coli.
Protein and Light-Absorbing Impurities: To pass the test.
Acidity or Alkalinity:
Sample solution: Dissolve 6 g by heating in 25 mL of carbon dioxide-free water, cool, and add 0.3 mL of phenolphthalein.
Acceptance criteria: The solution is colorless, and NMT 0.4 mL of 0.1 N sodium hydroxide is required to produce a pink or red color.
Optical Rotation, Specific Rotation:
Sample solution: Dissolve 10 g by heating in 80 mL of water to 50°. Allow to cool, and add 0.2 mL of 6 N ammonium hydroxide. Allow to stand for 30 min, and dilute with water to 100 mL.
Acceptance criteria: +54.4° to +55.9°, calculated on the anhydrous basis, at 20C.
Lactose Monohydrate Analytical Reagent Grade Specifications:
C12H22O11-H2O --- Formula Weight 360.32
CAS Number 64044-51-5
REQUIREMENTS
Water (H2O): 4.0-6.0%
MAXIMUM ALLOWABLE
Insoluble matter: 0.005%
Residue after ignition: 0.03%
Dextrose: Passes test
Sucrose: Passes test
Heavy metals (as Pb): 5 ppm
Iron (Fe): 5 ppm.
Directly Compressible Lactose Monohydrate (Agglomerated) USP/NF:
Lactose monohydrate in a fine form can be compressed into hard tablets, but it exhibits poor flow. The goal of the secondary processes that convert lactose into directly compressible grades is to maintain the inherent compressibility of fine lactose, whilst improving the flow. Directly compressible lactose, manufactured by a continuous spray agglomeration process, where water is used as the binder and is sprayed onto fluidized fine milled lactose particles, creating liquid bridges to form agglomerated lactose.
We also supply Lactose monohydrate of BP Ph Eur grade.
Please visit SDS Safety Data Sheet of Directly Compressible Lactose Monohydrate n Lactose Monohydrate Anhydrous Suppliers.
American Molecules, also known as ammol.org is a distributor, supplier and manufacturers' representative of all types of Pharmaceuticals, Functional Ingredients, Excipients and Specialty Chemicals in Texas USA. Our principals manufacture supply and export USP NF BP, Ph Eur, etc grades of chemicals pure and reagent grade, mineral fortifiers, FCC food grade. Tailor made particle size and customized specifications are offered. The principal's facility is having one or more of the certifications like FDA approval and GLP, cGMP, ISO9001, ISO14001, ISO/IEC 17025, ISO22000, FSSC 22000, ISO45001, FSSAI, Kosher, HALAL, COPP, WHO-GMP certified and Written Confirmation (WC) for export to Europe is available. The manufacturers suppliers and exporters observe WHO Good Manufacturing Practices and Good Laboratory Practices.
Suppliers and Manufacturers' Representative:
9910 Bent Oak Dr
Houston, TX 77040, USA
Call Toll Free: 1-855-55-AMMOL 1-855-552-6665
Email: info@ammol.org