CAS Number 9050-31-1, Hypromellose Phthalate or Hydroxypropyl Methycellulose Phthalate BP Ph Eur USP NF Grade Manufacturers Exporters
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CAS Number 9050-31-1, Hypromellose Phthalate or Hydroxypropyl Methycellulose Phthalate or HPMC-P BP Ph Eur USP NF Grade Manufacturer Exporter
For Properties Specifications of Hypromellose Phthalate or Hydroxypropyl Methycellulose Phthalate or HPMC-P Click Properties, Specifications of Hypromellose Phthalate or Hydroxypropyl Methycellulose Phthalate or HPMC-P Manufacturer.
For Uses of Hypromellose Phthalate or Hydroxypropyl Methycellulose Phthalate or HPMC-P Click Uses of Hypromellose Phthalate or Hydroxypropyl Methycellulose Phthalate or HPMC-P Manufacturer.
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The Properties and Specifications of Hypromellose Phthalate or Hydroxypropyl Methycellulose Phthalate or HPMC-P:
Specifications of Hypromellose Phthalate BP Ph Eure Grade:
DEFINITION
Hydroxypropylmethylcellulose phthalate.
Monophthalic acid ester of hypromellose, containing methoxy (-OCH3), 2-hydroxypropoxy (-OCH2CHOHCH3) and phthaloyl (o-carboxybenzoyl C8H5O3) groups.
CHARACTERS
Appearance: White or almost white, free-flowing flakes or granular powder.
Solubility: Practically insoluble in water, soluble in a mixture of equal volumes of acetone and methanol and in a mixture of equal volumes of methanol and methylene chloride, very slightly soluble in acetone and in toluene, practically insoluble in anhydrous ethanol.
IDENTIFICATION
Infrared absorption spectrophotometry.
Preparation Dissolve 40 mg in 1 mL of a mixture of equal volumes of methanol and methylene chloride; spread 2 drops of this solution between 2 sodium chloride plates, then remove one of the plates to evaporate the solvent.
Comparison hypromellose phthalate CRS.
TESTS
Free phthalic acid: To pass the test.
Limit: -- phthalic acid: not more than 0.4 times the area of the corresponding peak in the chromatogram obtained with the reference solution (1.0 per cent).
Chlorides: Maximum 0.07 per cent.
Water: Maximum 5.0 per cent, determined on 0.500 g.
Sulfated ash: Maximum 0.2 per cent, determined on 1.0 g.
Apparent viscosity: 80 per cent to 120 per cent of the nominal value.
Solubility: 0.2 g does not dissolve in 0.1 M hydrochloric acid but dissolves quickly and completely in 100 mL of phosphate buffer solution pH 6.8 with stirring.
Phthaloyl groups: Typically 21.0 per cent to 35.0 per cent (anhydrous substance).
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% to 35% 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% to 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.
The Uses of Hypromellose Phthalate or Hydroxypropyl Methycellulose Phthalate or HPMC-P:
Hydroxypropyl Methy Cellulose Phthalate or HPMC-P or Hydroxypropyl Methycellulose Phthalate or Hypromellose Phthalate is 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.
The MSDS-SDS Hazard Statement of Hypromellose Phthalate or Hydroxypropyl Methycellulose Phthalate or HPMC-P:
Hydroxypropyl Methycellulose Phthalate or Hydroxypropyl methyl cellulose phthalate or HPMC-P or Hypromellose Phthalate SDS GHS, Safety Data Sheet
MSDS Sheet, Material Safety Data Sheet 24-Nov-24
Section 1: Chemical Product and Company Identification
Product Name & Other Names: Hydroxypropyl Methycellulose Phthalate or Hydroxypropyl methyl cellulose phthalate or HPMC-P or Hypromellose Phthalate.
CAS Number: 9050-31-1
EINECS EC Code: 232-674-9 or 618-567-3
Relevant uses and uses advised against (if any): Industrial Manufacturing.
Suppliers: As per letterhead.
Section 2: Hazards Identification
GHS, Globally Harmonized System Classification in accordance with 29 CFR 1910
Hazard Class and Category Code(s), Regulation (EC) No 1272/2008 (CLP)
Not a hazardous substance or mixture according to Regulation (EC) No. 1272/2008.
This substance is not classified as dangerous according to Directive 67/548/EEC.
Labeling Regulation as per GHS & EC 1272/2008 (CLP) & GHS
GHS Label Elements NONE |
Signal Word: None
Precautionary statements:
P261: Avoid breathing dust/fume/gas/mist/vapors/spray.
P262: Do not get in eyes, on skin, or on clothing.
P281: Use personal protective equipment as required.
P302+P352: IF ON SKIN: Wash with plenty of soap and water.
P304+P340: IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P337+313: If eye irritation persists get medical advice/attention.
Section 3: Composition and Information on Ingredients
Product Name & Other Names: Hydroxypropyl Methycellulose Phthalate or Hydroxypropyl methyl cellulose phthalate or HPMC-P or Hypromellose Phthalate.
CAS Number: 9050-31-1
EINECS EC Code: 232-674-9 or 618-567-3
Section 4: First Aid Measures
Always seek medical advice after the first aid treatment.
Skin: Rinse with water. Soap may be used. Seek Medical Aid.
Eyes: Wash eyes with plenty of water for at least 15 minutes, lifting lids occasionally. Seek Medical Aid.
Inhalation: Remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen.
Ingestion: If swallowed, induce vomiting immediately after giving two glasses of water. Never give anything by mouth to an unconscious person.
Section 5: Fire and Explosion Data
Products of Combustion: Oxides of Carbon.
Fire Fighting Media and Instructions: Use water spray, alcohol-resistant foam, dry chemical or carbon dioxide. Wear self-contained breathing apparatus for firefighting if necessary.
Special Information: In the event of a fire, wear full protective clothing and NIOSH-approved self-contained breathing apparatus with full face piece operated in the pressure demand or other positive pressure mode.
Section 6: Accidental Release Measures
Personal precautions, protective equipment and emergency procedures: Avoid breathing dust/fumes/gas/mist/vapors/spray. Ensure adequate ventilation. Use individual protective equipment (waterproof boots, suitable protective clothing, safety glasses, etc.).
Environmental precautions: Do not let the product enter drains, soil or water sources.
Methods and materials used for containment Cleanup procedures and Storage:
Small Spill: Use appropriate tools to put the spilled solid in a convenient waste disposal container.
Large Spill: Contain spilled material. Do not inhale vapors, mist, or gas. Avoid dust formation. Use a shovel to put the material into a convenient waste disposal container.
Section 7: Handling and Storage
Precautions for safe handling: Apply according to good manufacturing and industrial hygiene practices. Ensure proper ventilation. Wash thoroughly after handling. Do not drink, eat or smoke while handling. Avoid contact with skin, eyes and clothing. Minimize dust generation. Avoid breathing dust/fumes/gas/mist/vapors/spray. Keep container tightly closed. Avoid ingestion and inhalation. Use individual protective equipment (waterproof boots, suitable protective clothing, safety glasses, etc.).
Conditions for safe storage, including any incompatibilities: Store in cool, dry and ventilated area away from heat sources and protected from sunlight in tightly closed original container. Keep air contact to a minimum. Do not leave the material container open. Store protected from heat, sparks and ignition sources and incompatible materials. Avoid inhalation of dust/mist/vapor. Do not store with incompatible materials like oxidizing agents, acids.
Section 8: Exposure Controls/Personal Protection
Exposure Guidelines: This product does not contain any hazardous materials with occupational exposure limits established by the region-specific regulatory bodies.
Engineering Controls: Use process enclosures, local exhaust ventilation, or other engineering controls to keep airborne levels low.
Ventilation System: A system of local and/or general exhaust is recommended to keep employee exposures as low as possible.
Personal Respirators (NIOSH Approved): For conditions of use where exposure to dust or mist is apparent and engineering controls are not feasible, a particulate respirator may be worn.
Skin Protection: Wear protective gloves and clean body-covering clothing.
Eye Protection: Use chemical safety goggles and/or full face shield where dusting or splashing of solutions is possible. Maintain eye wash fountain and quick-drench facilities in work area.
Other Control Measures: Maintain good housekeeping in work area. Handle in accordance with good industrial hygiene and safety practice. Wash hands after handling.
Section 9: Physical and Chemical Properties
Physical state and appearance: White or almost white, free-flowing flakes or granular powder.
Odor: No data found.
Odor threshold: No data found.
pH: No data found.
Relative density: No data found.
Melting point/freezing point: No data found.
Initial boiling point and boiling range: No data found.
Flash point: No data found.
Auto-ignition temperature: No data found.
Decomposition temperature: No data found.
Upper/lower flammability or explosive limits: No data found.
Vapor pressure: No data found.
Vapor density: No data found.
Evaporation rate: No data found.
Flammability (solid, gas): No data found.
Partition coefficient: n-octanol/water: No data found.
Solubility: Practically insoluble in water, soluble in a mixture of equal volumes of acetone and methanol and in a mixture of equal volumes of methanol and methylene chloride.
Viscosity: As per label.
Section 10: Stability and Reactivity Data
Stability: It is stable in room temperature in closed containers under normal storage & handling.
Conditions of instability: Incompatible materials, Strong oxidizers. May react vigorously with bleaching powder, Fluorine, Nitric acid.
Incompatibility with various substances: Avoid high temperatures, sparks, open flames and moisture. Avoid contact with strong oxidizing agents.
Polymerization: Will not occur.
Section 11: Toxicological Information
LD50 Oral - Rat: No data found.
Carcinogenic Effects: Not a reported carcinogen by IARC, NTP, ACGIH, OSHA.
Reproductive toxicity: No data found.
Teratogenicity: No data found.
Developmental Effects: No data found.
Section 12: Ecological Information
Toxicity to fish: No data found.
Persistence and Degradability: No data found.
Bioaccumulation/ Accumulation: No data found.
Mobility: No data found.
Section 13: Disposal Considerations
Waste Disposal: Waste must be disposed of in accordance with federal, state and local environmental control regulations. Follow all the pollution control laws.
Section 14: Transport Information
DOT USA, TDG Canada & ADR/RID Europe: Not controlled.
IMDG: Not controlled.
IATA: Not controlled.
Section 15: Other Regulatory Information
USA Regulations:
SARA 311/312 Hazard Categories: See section 2.
California Prop 65: Not listed.
Disclaimer:
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Our company provides this MSDS sheet in good faith but makes no representation as to its comprehensiveness or accuracy. This SDS sheet is intended only as a guide to the appropriate precautionary handling of the material by a properly trained person using this product. The above information has been compiled from various sources and has the possibility of discrepancy and being out-dated information. Individuals receiving the information must exercise their independent judgment and do further search in determining its appropriateness for a particular purpose. In no case shall our company be liable to loss or damages by the product user.
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Anmol Chemicals & Pharmaceuticals Pvt. Ltd. is an off-shoot of Anmol Chemicals Taloja. It is located in MIDC Taloja and it is manufacturing pharmaceutical grades of API, Excepients, Food grade and Reagent grade chemicals. Anmol Chemicals & Pharmaceuticals Pvt. Ltd. is a several decades old group of companies, engaged in manufacturing, supplying, distributing, wholesale supplies for actual users, retail or small pack supplies for research and development chemicals, fine and speciality chemicals, pharmaceutical excipients, mineral fortifiers in chemically pure, Analytical reagent grade, IP BP USP Ph Eur EP JP and other pharmaceutical grade monograph including FCC Food grade chemicals and Nutraceuticals, Mineral Fortifiers at best prices.
Hypromellose Phthalate or Hydroxypropyl Methycellulose Phthalate or HPMC-P Structure
CAS Number 9050-31-1, Hypromellose Phthalate or Hydroxypropyl Methycellulose Phthalate or HPMC-P Manufacturer Exporter
ANMOL CHEMICALS & PHARMACEUTICALS Pvt. Ltd.
India, USA, Europe, UAE
TELEPHONE: +912223770100
Navi Mumbai, INDIA
e-mail: info(At the rate i.e. @)anmol.org
Copyright. 10-dec-24
We manufacture:
Hydroxyethyl Salicylate or Glycol Salicylate
Hypromellose Phthalate or Hydroxypropyl Methycellulose Phthalate