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PHARMACOAT® 645

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

PHARMACOAT® 645 is a binder, it does not interact with drugs. It has superior stability, a non-ionic character and is widely used as a binder for granulation. Due to its plant derived nature and excellent moisture stability, PHARMACOAT®® replaces gelatin in hard capsule manufacturing. It is easy to use as a film coating material that provides an excellent finish . It is also used as taste making agent for bitter tasting drugs.

Properties

Pharma and Nutraceuticals Functions
  • Coating System
  • Film Coating Agent

Product families

Applications

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

Product Families

Pharmaceuticals & Nutraceuticals — Excipients
  • Pharmaceutical Coatings

Other characteristics

Brand
PHARMACOAT
Functions
Coating System, Film Coating Agent
Dosage Form
  • Capsules, Tablets
  • Capsules
  • Tablets
Labeling Claims

Allergen-free, BSE-free, Kosher, Non-GMO, Solvent-free, TSE-free; Allergen-free; BSE-free; Kosher; Non-GMO; Solvent-free; TSE-free

Certifications & Compliance

DMF Type IV, European Pharmacopeia (Ph. Eur.), FDA Compliant, GMP, Generally Recognized As Safe (GRAS), Japan Pharmacopeia (JP), Kosher, The Food Allergen Labeling & Consumer Protection Act of 2004 (FALCPA), United States Pharmacopeia (USP)

Note
*Viscosity of 2 w/w % aqueous solution at 20°C
Grade
Pharma Grade
Markets
Healthcare & Pharma
PACKAGE

50kg - Fiber drum with polyethylene double bag inside; 1kg - Polyethylene double bag

Storage

Keep dry. Store away from excess heat and sunlight. Store in sealed containers.

Features

Low viscosity, suitable for film coating with water or solvent (co-solvent of water and ethanol) coating system.; Water soluble and non-ionic, less interaction with active pharmaceutical ingredient (API).; Applicable as a binder in wet granulation. Low viscosity and soluble polymer, helpful to obtain granules with uniform particle size and good flowability.; Applicable also as a solid dispersion carrier.

Application
  • Film Coating
  • Granulation
Technology
Pharmaceuticals & Nutraceuticals
Packaging Type
  • Bags
  • Drums
Chemical Inventories
  • AICS (Australia)
  • DSL (Canada)
  • ENCS (Japan)
  • NZIoC (New Zealand)
  • PICCS (Phillipines)
  • TCSI (Taiwan)
  • TSCA (USA)
Certifications and Compliance

DMF Type IV; European Pharmacopeia (Ph. Eur.); FDA Compliant; GMP; Generally Recognized As Safe (GRAS); Japan Pharmacopeia (JP); Kosher; The Food Allergen Labeling & Consumer Protection Act of 2004 (FALCPA); United States Pharmacopeia (USP)

Technical data

Table 1 of 1

3 rows
CharacteristicValueUnit
Hydroxypropoxy Content7.0 - 12.0%
Methoxy Content28.0 - 30.0%
Viscosity3.6 - 5.1mPas

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