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Hydroxypropyl Methycellulose Phthalate or Hypromellose Phthalate USP NF BP Ph Eur Grade Supplier Exporter Manufacturers' Representative |
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Hydroxypropyl Methycellulose Phthalate or Hypromellose Phthalate
CAS Number: 9050-31-1
Hydroxypropyl Methycellulose Phthalate or Hypromellose Phthalate
Hydroxypropyl Methycellulose Phthalate or Hypromellose Phthalate mainly used in tablets, granules etc. and also widely used in aquaculture, biotechnology and other industries. In the pharmaceutical industry, hypromellose phthalate is used as a coating agent for tablets and granules.
Specifications of Hypromellose Phthalate USP NF Grade:
DEFINITION
Hypromellose Phthalate is a monophthalic acid ester of hydroxypropyl methylcellulose. It contains methoxy (-OCH3 ), hydroxypropoxy (-OCH2CHOHCH3 ), and phthalyl (o-carboxybenzoyl, C8H5O3 ) groups. It contains NLT 21.0% and NMT 35.0% of phthalyl groups, calculated on the anhydrous basis.
IDENTIFICATION
A. Infrared Absorption: Do not dry specimens.
Phthalyl Content: To pass the test.
Acceptance criteria: 21.0%–35.0% of phthalyl groups on the anhydrous basis.
Residue on Ignition: NMT 0.20%
Chloride and Sulfate, Chloride:
Sample solution: Dissolve 1.0 g in 40 mL of 0.2 N sodium hydroxide, add 1 drop of phenolphthalein and add 2 N nitric acid dropwise, with stirring, until the red color is discharged. Add an additional 20 mL of 2 N nitric acid with stirring. Heat on a water bath, with stirring, until the gel-like precipitate formed becomes granular. Cool the mixture, and centrifuge. Separate the liquid phase and wash the residue with three successive 20-mL portions of water, separating the washings by centrifuging. Dilute the combined liquids with water to 200 mL, mix, and filter.
Standard solution: Treat 0.50 mL of 0.01 N hydrochloric acid with 10 mL of 0.2 N sodium hydroxide, add 7 mL of 2 N nitric acid, and dilute with water to 50 mL.
Acceptance criteria: A 50-mL portion of the Sample solution shows no more chloride than the Standard solution (0.07%).
Limit of Free Phthalic Acid:
Acceptance criteria: NMT 1.0%
Water Determination: NMT 5.0%
Viscosity-Capillary: To pass the test.
Acceptance criteria: 80%–120% of that indicated by the label.
Packaging and Storage: Preserve in tight containers.
Labeling: Label it to indicate its viscosity and nominal phthalyl content.
Hypromellose Phthalate or Hydroxypropyl Methycellulose Phthalate is also available as per BP Ph Eure monograph.
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