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Hypromellose or Hydroxypropyl Methylcellulose or Hydroxy Propyl Methyl Cellulose or HPMC or Hydroxy Propyl Methyl Cellulose USP FCC Food Grade Supplier Exporter Manufacturers' Representative |
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Hypromellose or Hydroxypropyl Methylcellulose or HPMC or Hydroxy Propyl Methyl Cellulose
CAS Number: 9004-65-3
Molecular Formula: Varies
Molecular Weight: Varies
Hypromellose or Hydroxypropyl Methylcellulose or HPMC or Hydroxy Propyl Methyl Cellulose
Specifications of Hypromellose USP Grade:
Cellulose, 2-hydroxypropyl methyl ether
Cellulose hydroxypropyl methyl ether --- CAS 9004-65-3
DEFINITION
Hypromellose is a methyl and hydroxypropyl mixed ether of cellulose. It contains, calculated on the dried basis, methoxy (– OCH3 : 31.03) and hydroxypropoxy (– OC3H6OH: 75.09) groups conforming to the limits for the types of Hypromellose (hydroxypropyl methylcellulose) set forth in the table below.
Substitution Type 1828; Methoxy% 16.5 to 20; Hydroxypropoxy% 23 to 32
Substitution Type 2208; Methoxy% 19.0 to 24; Hydroxypropoxy% 4 to 12
Substitution Type 2906; Methoxy% 27.0 to 30; Hydroxypropoxy% 4 to 7.5
Substitution Type 2910; Methoxy% 28.0 to 30; Hydroxypropoxy% 7 to 12
IDENTIFICATION
A.
Sample: 1 g
Analysis: Gently add the Sample to the top of 100 mL of water in a beaker, and allow to disperse over the surface, tapping the top of the container to ensure an even dispersion of the substance. Allow the beaker to stand for 1 - 2 min.
Acceptance criteria: The powdered material aggregates on the surface.
B.
Sample: 1 g
Analysis: Add the Sample to 100 mL of boiling water, and stir the mixture using a magnetic stirrer with a bar 25-mm long.
Acceptance criteria: A slurry is formed, but the powdered material does not dissolve. Cool the slurry to 10C and stir using a magnetic stirrer: the resulting liquid is a clear or slightly turbid solution with thickness dependent on the viscosity grade.
C.
Solution A: Sulfuric acid and water (9 in 10). [Note— Carefully add sulfuric acid to water. ]
Sample solution: 0.1 mL of the solution prepared for Identification test B
Analysis: To the Sample solution add 9 mL of Solution A, and shake. Heat in a water bath for exactly 3 min, immediately cool in an ice bath, and add carefully 0.6 mL of ninhydrin. Shake and allow to stand at 25C.
Acceptance criteria: A red color develops at first that changes to purple within 100 min.
D.
Sample solution: 2–3 mL of the solution prepared for Identification test B
Analysis: Pour the Sample solution onto a glass slide as a thin film, and allow the water to evaporate.
Acceptance criteria: A coherent, clear film forms on the glass slide.
E.
Sample solution: 50 mL of the solution prepared in Identification test B
Analysis: Add the Sample solution to exactly 50 mL of water in a beaker. Insert a thermometer into the solution. Stir the solution on a magnetic stirrer/hot plate and begin heating at a rate of 2C - 5C/min. Determine the temperature at which a turbidity increase begins to occur, and designate this temperature as the flocculation temperature.
Acceptance criteria: The flocculation temperature is higher than 50C.
Residue on Ignition:
Sample: 1.0 g
Acceptance criteria: NMT 1.5%
pH:
Sample: Use the solution prepared in the tests for Viscosity.
Analysis: Read the indicated pH value after the probe has been immersed for 5 ± 0.5 min.
Acceptance criteria: 5.0 - 8.0
Loss on Drying:
Sample: 1.0 g
Analysis: Dry the Sample at 105C for 1 h.
Acceptance criteria: NMT 5.0%
Viscosity: To pass the test.
Acceptance criteria: 75% 140% of the viscosity stated on the label
Specifications of Hydroxypropyl Methylcellulose FCC Food Grade:
Propylene Glycol Ether of Methylcellulose; Modified Cellulose, HPMC
INS: 464 CAS 9004-65-3
DESCRIPTION
Hydroxypropyl Methylcellulose occurs as a white to off-white, fibrous powder or as granules. It is the propylene glycol ether of methylcellulose in which both the hydroxypropyl and the methyl groups are attached to the anhydroglucose rings of cellulose by ether linkages. Several product types are available that are defined by varying combinations of methoxyl and hydroxypropoxyl content. It is soluble in water and in certain organic solvent systems. Aqueous solutions are surface active, form films upon drying, and undergo a reversible transformation from sol to gel upon heating and cooling, respectively.
Function: Thickening agent; stabilizer; emulsifier.
REQUIREMENTS
Identification:
A. Add 1 g of sample to 100 mL of water. It swells and disperses to form a clear to opalescent, mucilaginous solution, depending on the intrinsic viscosity, which is stable in the presence of most electrolytes.
B. Add 1 g of sample to 100 mL of boiling water, and stir the mixture. A slurry forms that when cooled to 20C, dissolves to form a clear or opalescent, mucilaginous solution.
C. Pour a few milliliters of the solution prepared for Identification Test B onto a glass plate and allow the water to evaporate. A thin, self-sustaining film forms.
Assay for Hydroxypropoxyl Groups: Between a minimum of 3.0% and a maximum of 12.0% of hydroxypropoxyl groups (-OCH2CHOHCH3), within the range claimed by the vendor for any product type.
Assay for Methoxyl Groups: Between a minimum of 19.0% and a maximum of 30.0% of methoxyl groups (-OCH3), within the range claimed by the vendor for any product type.
Lead: Not more than 3 mg/kg.
Loss on Drying: Not more than 5.0%.
Residue on Ignition: Not more than 1.5% for products with viscosities of 50 centipoises or above; not more than 3.0% for products with viscosities below 50 centipoises.
Viscosity: The viscosity of an aqueous solution containing 2 g of sample per 100 g of solution is not less than 80.0% and not more than 120.0% of that stated on the label for viscosity types of 100 centipoises or less, and not less than 75.0% and not more than 140.0% of that stated on the label for viscosity types higher than 100 centipoises.
We also supply Hypromellose or Hydroxypropyl Methylcellulose or HPMC or Hydroxy Propyl Methyl Cellulose BP Ph Eur Grade.
Please visit SDS Safety Data Sheet of Hypromellose or Hydroxypropyl Methylcellulose or HPMC 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:
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Houston, TX 77040, USA
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