PEARLITOL® CR-H - HYPROMELLOSE – MANNITOL

1 of 13 products in this brand
PEARLITOL® CR-H - HYPROMELLOSE – MANNITOL is a combination of hypromellose (HPMC) and mannitol that offers excipient functional properties for tablet formulations. It serves as a binder while also providing controlled release characteristics. Specifically designed for direct compression formulations, Pearlitol® CR-H is suitable for use in oral tablets for both pharmaceutical and nutraceutical applications that require controlled properties.

Chemical Name: Hydroxypropyl Methylcellulose, Mannitol

Functions: Binder, Controlled Release Agent

Dosage Form: Lozenges, Tablets

Certifications & Compliance: Chinese Pharmacopeia (ChP), European Pharmacopeia (Ph. Eur.), FDA 29 CFR 1910.1200, Japan Pharmacopeia (JP), National Formulary (NF), United States Pharmacopeia (USP)

Knowde Enhanced TDS

Identification & Functionality

Pharma & Nutraceuticals Functions
Chemical Structure

Mannitol Hydroxypropyl methylcellulose


Morphology

Features & Benefits

Key Attributes
  • Uses multicompendial ingredients

Applications & Uses

Dosage Form
Manufacturing Technology
Product Applications

PEARLITOL® CR-H co-processed mannitol HPMC is a direct compression excipient providing functional properties of binder as well as controlled release to your tablet. PEARLITOL® CR-H can be used in both pharmaceutical and nutraceutical oral dosage forms.

Properties

Physical Form
Appearance
White to yellowish-white powder or granules
Odor
Neutral taste, slightly sweet
Partially Soluble in
Cold water
Typical Properties
ValueUnitsTest Method / Conditions
Loss On Dryingmax. 4.0%
pH5 - 8
D-Mannitol (as is)25 - 35%
Hypromellose (as is)65 - 75%
Sulfated Ashmax. 1.0%
Bulk Density300 - 500g/l
Molecular Weight182.2g/mol
Water Contentmax. 4%
Average Mean Particle Diameter150.0µm
Particle Size Distribution (dv10)60.0µmLaser Diffraction
Particle Size Distribution (dv50)140.0µmLaser Diffraction
Particle Size Distribution (dv90)290.0Laser Diffraction
Melting Temperature165 - 170°C
Powder Flowability12.0seconds
Tapped Density0.43g/cm³
True Density1.456g/cm³
Specific Surface Area0.8m²/g
Microbiological Values
ValueUnitsTest Method / Conditions
Total Aerobic Microbial Countmax. 1000CFU/g
Total Yeasts and Molds Countmax. 100CFU/g
Escherichia ColiNot detectedin 1g
SalmonellaNot detectedin 10g
Particle Size Distribution
ValueUnitsTest Method / Conditions
Particle (more than 500microns)max. 5%Laser
Particle (more than 315 microns)max. 25%Laser
Particle (more than 40 microns)min. 90%Laser

Regulatory & Compliance

Conformity

Meets the requirements of the current monograph of

  • European Pharmacopeia MANNITOL (0559) and HPMC
  • USP-NF Pharmacopeia MANNITOL and HPMC
  • Japanese Pharmacopeia D-MANNITOL and HPMC
  • Chinese Pharmacopeia MANNITOL and HPMC

Please contact us for any statement regarding compliance to the General Chapters (elemental impurities, residual solvents, organic volatile impurities, metal catalyst, metal reagent).

Technical Details & Test Data

Product Test Data

Water sorption isotherm at 20°C



Tablet Hardness


API Release Kinetics



 

Experimental Conditions for Compression Behavior

Tablet Press: STYLONE EVO
Production Speed:
30 and 65 RPM (linear punch velocity: 49 and 91 mm/s; simulated KORSCH XL-400 rotary press speed: 63,000 and 136,500 tablets/hour)
Tooling: Diameter 13 mm flat
Formula: PEARLITOL® CR-H / external lubrication with magnesium stearate
Tablet Mass: 400 mg

Experimental Conditions for Sustained Release Behavior

Tablet press: STYL'ONE EVO
Production speed: 30 RPM (linear punch velocity: 49 mm/s; simulated KORSCH XL-400 rotary press speed: 63,000 tablets/hour)
Tooling: Diameter 13 mm flat
Formula: 50% Metformin / 49% PEARLITOL® CR-H / 1% magnesium stearate
Tablet mass: 1,000 mg
Tablet hardness: 109 N
Tablet thickness: 6.8 mm
Dissolution bath: USP II with helical sinker
Release media: pH transition method adapted from US <711> Dissolution Method A

Storage & Handling

Shelf Life
3 years
Storage Condition
  • Manufacturing date: 3 years, in its unopened packaging.
  • These dates are indicative and may vary according to packaging type and manufacturing plant. Proper information is shown on labeling and CoA.
  • We recommend to preserve the product in its unopened original packaging, preferably protected from wide variations of temperature and humidity.
  • Upon opening, use the product as quickly as possible to prevent moisture regain.