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TYLOPUR® 615

CAS Number
9004-65-3
EC Number
618-389-6
Chemical Name
Hydroxypropyl Methylcellulose

TYLOPUR® 615 is a versatile hypromellose, compliant with USP, JP, EP. It is a film coating material that provides an excellent finish.It is a effective binder, it does not interact with drugs. It is an excellent taste making agent for bitter tasting drugs.

Properties

Physical Form
  • Powder
  • Solid
Pharma and Nutraceuticals Functions
  • Binder
  • Coating System
  • Thickener
  • Viscosity Modifier

Product families

Applications

Healthcare & Pharma — Drug Delivery & Care Solutions
  • Oral
Healthcare & Pharma — Pharmaceutical Manufacturing
  • Excipients & Coatings

Product Families

Pharmaceuticals & Nutraceuticals — Excipients
  • Binders & Disintegrants
  • Formulation & Processing Aids
  • Pharmaceutical Coatings

Other characteristics

Brand
TYLOPUR
Functions

Binder, Coating System, Thickener, Viscosity Modifier

Dosage Form
  • Capsules, Syrups
  • Capsules
  • Syrups
Certifications & Compliance

European Pharmacopeia (Ph. Eur.), GMP, Japan Pharmacopeia (JP), United States Pharmacopeia (USP)

Note

Harmonized items among the USP, EP and JP; Specific local attribute in EP; Viscosity is measured with 2 % aqueous solution at 20 °C. Viscosity ranges are 80 % – 120 % of the nominal value for samples with a viscosity less than 600 mPa.s and 75 % – 140 % of the nominal value for samples with 600 mPa.s or higher. Viscosity is hormonized item among the USP, EP and JP.

Grade
Pharma Grade
Markets
Healthcare & Pharma
Appearance
Conforms
Technology
Pharmaceuticals & Nutraceuticals
Packaging Type
  • Boxes
  • Drums
Storage Information

Keep dry. Store away from excess heat and sunlight.; Store preferentially in original packaging.

Chemical Inventories
  • AICS (Australia)
  • DSL (Canada)
  • EEC/EU
  • EINECS (EU)
  • ENCS (Japan)
  • IECSC (China)
  • KECI (Korea)
  • NZIoC (New Zealand)
Applications
  • Tablet/ pellet film coating
  • Granulation binder
  • Suitable for capsule shell
  • Suitable for dry syrup
  • Suitable for oral strips
Packaging Information

Fiber drum (40-50 kg) with polyethylene single bag inside of 450 mm x h 740 mm(110 liters).

Regulatory Information
  • EU-Regulations
  • National regulations
Manufacturing Technology
  • Direct Compression
  • Dry Granulation
  • Wet Granulation
Certifications and Compliance
  • European Pharmacopeia (Ph. Eur.)
  • GMP
  • Japan Pharmacopeia (JP)
  • United States Pharmacopeia (USP)
Key Quality Attributes in Matrix Tablets
  • Decrease in initial erosion
  • Faster drug release
  • No effect on tablet hardness

Technical data

Table 1 of 1

27 rows
CharacteristicValueUnitMethod
Heavy Metalsmax. 20ppmEP
Viscosity3 - 15mPa.s—
Viscosity4.0 - 6.0mPa.sEP
HPMC6.75%w/w—
Hydroxypropoxy Content7.0 - 12.0%EP
Loss on Dryingmax. 5.0%EP
Talc2.85%w/w—
Methoxy Content28.0 - 30.0%EP
TiO₂3.9%w/w—
pH5.0 - 8.0—EP
Pigment0.15%w/w—
PEG 60001.35%w/w—

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