Enhanced TDS
Knowde-enriched technical product data sheet
Identification & Functionality
- Chemical Name
- Pharma & Nutraceuticals Functions
- Technologies
- Product Families
- Chemical Structure
Mannitol Hydroxypropyl methylcellulose
- Morphology
Features & Benefits
- Key Attributes
- Uses multicompendial ingredients
Applications & Uses
- Markets
- Applications
- 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
Value Units Test Method / Conditions Loss On Drying max. 4.0 % - pH 5 - 8 - - D-Mannitol (as is) 25 - 35 % - Hypromellose (as is) 65 - 75 % - Sulfated Ash max. 1.0 % - Bulk Density 300 - 500 g/l - Molecular Weight 182.2 g/mol - Water Content max. 4 % - Average Mean Particle Diameter 150.0 µm - Particle Size Distribution (dv10) 60.0 µm Laser Diffraction Particle Size Distribution (dv50) 140.0 µm Laser Diffraction Particle Size Distribution (dv90) 290.0 - Laser Diffraction Melting Temperature 165 - 170 °C - Powder Flowability 12.0 seconds - Tapped Density 0.43 g/cm³ - True Density 1.456 g/cm³ - Specific Surface Area 0.8 m²/g - - Microbiological Values
Value Units Test Method / Conditions Total Aerobic Microbial Count max. 1000 CFU/g - Total Yeasts and Molds Count max. 100 CFU/g - Escherichia Coli Not detected in 1g - Salmonella Not detected in 10g - - Particle Size Distribution
Value Units Test 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
- Certifications & Compliance
- Grade
- Quality Standards
- 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.