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HPMCP HP-55

HPMCP is a monophthalic acid ester of hypromellose.HP-55 is a regular grade enteric coating agent.

Brand: HPMCP (4 products)

Chemical Name: Hypromellose Phthalate

Functions: Coating System, Controlled Release Agent, Extended Release Agent, Taste Masker

Dosage Form: Capsules, Pellets, Tablets

Labeling Claims: Allergen-free, BSE-free, Kosher, Non-GMO, TSE-free

Certifications & Compliance: DMF Type IV, European Pharmacopeia (Ph. Eur.), GMP, Japan Pharmacopeia (JP), Kosher, National Formulary (NF), The Food Allergen Labeling & Consumer Protection Act of 2004 (FALCPA), United States Pharmacopeia (USP)

Enhanced TDS

Knowde-enriched technical product data sheet

Identification & Functionality

Features & Benefits

Labeling Claims
Features
  • Suitable for solvent coating system. As co-solvents, mixture of ethanol and water (80/20 w/w%) or mixture of acetone and water (95/5 w/w%) are recommendable.
  • Relatively stable, due to less hydrolysis.
  • Available as a solid dispersion carrier for solubility enhancement.

Applications & Uses

Markets
Applications
Dosage Form
Manufacturing Technology
Application
  • HPMCP is Very Suitable for Taste Masking
  • HPMCP is Very Suitable for Enteric/delayed release coating (solvent)
  • HPMCP is Suitable for Solvent free methods
  • HPMCP is Very Suitable for Solvent methods
  • Tablet Coating
  • Granule Coating

Properties

Physical Form
Typical Properties
ValueUnitsTest Method / Conditions
ChlorideNot more than 0.07%USP/NF
Dissolving pHmin. 5.5--
Free phthalic AcidNot more than 1.0%USP/NF
Heavy MetalsNot more than 0.001%USP/NF
Hydroxy propoxy Content5.0 - 9.0%USP/NF
Labeled Viscosity40.0cSt-
Methoxy Content18.0 - 22.0%USP/NF
Nominal Phthalyl Content31.0%-
phthalyl Content27.0 - 35.0%USP/NF
Residue on ignitionNot more than 0.20%USP/NF
Viscosity32 - 48cStUSP/NF
Viscosity40.0mPa.S-
WaterNot more than 5.0%USP/NF
Note

*Viscosity of 10 w/w% solution of methanol and dichloromethane at 20°C

Solubility in Various Organic Solvents
  HPMCP Shin-Etsu
AQOAT
  HP-55
HP-55S
HP-50 AS-MG
Acetone
Acetone/water (95:5)*
Acetone/ethanol (1:1)*
Dichloromethane
Dichloromethane/ethanol (1:1)*
Dioxane
Methanol
Isopropanol × ×
Ethanol × × ×
Ethanol/water (8:2)*
Ether × × ×

○ : soluble, △ : swollen or partially soluble × : insoluble, * : mixing ratio by weight

Regulatory & Compliance

Technical Details & Test Data

Solubility

HPMCP HP-55 - Solubility

According to the disintegration test method, dissolution time was measured for cast film from organic solvent (thickness: 100 μ m; size: 10 x 10 mm)
〜 pH 5.6: USP Phthalate buffer
pH 5.8 〜: USP Phosphate buffer

Packaging & Availability

Packaging Type
Package
  • 25 kg - Fiber drum with polyethylene double bag inside
  • 1 kg - Polyethylene double bag

Storage & Handling

Storage

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