PEARLITOL® mannitol C - Monograph
Description
Mannitol crystalline powder
White, odourless, slightly sweet tasting, crystalline powder.
Compliance
- European Pharmacopoeia
- USP / NF
- Japanese Pharmacopoeia
Regulatory documentation
- CEP: R1CEP2000-039
- US DMF Type IV n° 18 143
Properties
Physical and chemical
- Very low hygroscopicity
- Excellent chemical stability
- Water solubility at 20°C = 17g / 100ml
Organoleptic
- Sweetening power about 40% that of sucrose
- Cooling effect in the mouth
Dietetic*
- Sugarless (non-cariogenic)
- May be advised for diabetics
- Low-calorie
Particle Size**
- PEARLITOL® 160 C
Mean diameter: 160 µm
- PEARLITOL® 50 C
Mean diameter: 50 µm
- PEARLITOL® 25 C
Mean diameter: 25 µm
Applications
- Diluent for tablets, capsules and sachets
- Excipient for chemically unstable or moisture sensitive actives
- Freeze-drying carrier
- Excipient of choice for flash release forms
- Sweetener for pharmaceutical chewing gum
- Diuretic-osmotic for injectable solutions : PEARLITOL® PF
* Refer to local legislation
** by laser diffraction
PEARLITOL® mannitol C - Formulation Assistance
TYPICAL FORMULATION
Roquette has developped a number of typical formulations to serve as basic guidelines for obtaining optimum performance from PEARLITOL® C products.
APPLICATIONS LABORATORY SERVICES & SUPPORT
Furthermore Roquette has long offered an integrated customer service for FORMULATION ASSISTANCE (see here presentation of Applications Laboratory Services & Support).
FORMULATION ASSISTANCE
For special formulations requests, please CONTACT US.
PEARLITOL® mannitol C - Sample Request
Early formulation is important and we recognize the need for formulators to have representative material for initial testing.
We can provide small non-commercial samples wherever you are in the world, with both the corresponding certificate of analysis and conformity and the material safety data sheet.
To obtain access to this service, please submit your sample or other request here.
Request a sample
PEARLITOL® mannitol C - Current packaging for this family of products
- 25 kg pinch bottom bag
- 50 kg fiber drum
- 500 kg big-bag
- 1 000 kg big-bag
To check the immediate availability of these packaging formats or other special packaging, please contact us or your local Roquette representative for further information.
