PEARLITOL® PF - MANNITOL PYROGEN FREE
PEARLITOL®
®Registered Trademark(s) of Roquette Frères
- High physicochemical and microbial purity and pyrogen-free .
Mannitol pyrogen free used as API as osmotic diuretic agent to reduce intracranial and introcular pressure
Used as Excipient as isotonic agent in Injectable and bulking agent for injectable freeze-dried powder.
Applications
- Injectable
- Large Volume Parenterals (LVP)
- Rx Injectable
Functional properties
- APIs
- Osmotic diuretic agent
- Excipients
- Bulking agent
- Isotonic agent
Physical and chemical properties
- CEP & DMF available
- White crystalline powder
Documents
Product Specification Sheet
Name
Region
Size
Download
PEARLITOL® PF
474,15 Ko
Region :
474,15 Ko
PEARLITOL® PF
476,97 Ko
Region :
476,97 Ko
PEARLITOL® PF
473,56 Ko
Region :
473,56 Ko
Safety Data Sheet
Name
Region
Language
Size
Download
PEARLITOL® PF
Oceania, AU
EN
274,39 Ko
Region : Oceania, AU
EN
274,39 Ko
PEARLITOL® PF
Europe, BE
EN
518,78 Ko
Region : Europe, BE
EN
518,78 Ko
PEARLITOL® PF
Europe, DE
EN
522,22 Ko
Region : Europe, DE
EN
522,22 Ko
PEARLITOL® PF
Europe, CH
EN
519,40 Ko
Region : Europe, CH
EN
519,40 Ko
PEARLITOL® PF
Asia, CN
EN
328,39 Ko
Region : Asia, CN
EN
328,39 Ko
PEARLITOL® PF
Europe, FI
EN
518,81 Ko
Region : Europe, FI
EN
518,81 Ko
PEARLITOL® PF
Europe, FR
EN
519,40 Ko
Region : Europe, FR
EN
519,40 Ko
PEARLITOL® PF
Europe, GB
EN
381,92 Ko
Region : Europe, GB
EN
381,92 Ko
PEARLITOL® PF
Europe, AT
DE
531,25 Ko
Region : Europe, AT
DE
531,25 Ko
PEARLITOL® PF
Europe, BE
DE
531,11 Ko
Region : Europe, BE
DE
531,11 Ko
PEARLITOL® PF
Europe, BE
FR
632,67 Ko
Region : Europe, BE
FR
632,67 Ko
PEARLITOL® PF
Europe, BE
NL
527,21 Ko
Region : Europe, BE
NL
527,21 Ko
PEARLITOL® PF
Americas, BR
PT
537,50 Ko
Region : Americas, BR
PT
537,50 Ko
PEARLITOL® PF
Europe, BG
BG
677,14 Ko
Region : Europe, BG
BG
677,14 Ko
PEARLITOL® PF
Europe, DE
DE
535,84 Ko
Region : Europe, DE
DE
535,84 Ko
PEARLITOL® PF
Americas, CA
FR
402,70 Ko
Region : Americas, CA
FR
402,70 Ko
PEARLITOL® PF
Europe, CH
DE
531,37 Ko
Region : Europe, CH
DE
531,37 Ko
PEARLITOL® PF
Europe, CH
FR
633,14 Ko
Region : Europe, CH
FR
633,14 Ko
PEARLITOL® PF
Europe, CH
IT
620,89 Ko
Region : Europe, CH
IT
620,89 Ko
PEARLITOL® PF
Asia, CN
ZH
645,89 Ko
Region : Asia, CN
ZH
645,89 Ko
PEARLITOL® PF
Europe, CZ
CS
650,25 Ko
Region : Europe, CZ
CS
650,25 Ko
PEARLITOL® PF
Europe, DK
DA
527,22 Ko
Region : Europe, DK
DA
527,22 Ko
PEARLITOL® PF
Europe, ES
ES
533,59 Ko
Region : Europe, ES
ES
533,59 Ko
PEARLITOL® PF
Europe, FI
FI
534,40 Ko
Region : Europe, FI
FI
534,40 Ko
PEARLITOL® PF
Europe, FR
FR
632,87 Ko
Region : Europe, FR
FR
632,87 Ko
Get in touch with our Technical Experts
Please feel free to contact our technical experts for support during the development process.
Technical data
| Synonyms | D-Mannitol |
|---|---|
| CAS number | 69-65-8 |
| Physical form or apperance | White or almost white crystalline powder |
| Application | PEARLITOL® PF pyrogen-free mannitol is used for parenteral preparations and provides excipient and API benefits. As an excipient, it is an isotonic agent and a bulking agent for freeze-dried powder for injection or infusion. As an API, it offers various functionalities: osmotic diuretic agent in small and large volume parenteral injectables, diagnostic agent for kidney function, adjunct in the treatment of an acute renal failure, reduction of intracranial pressure in the treatment of cerebral oedema, reduction of intraocular pressure and detoxifier. |
| Water sorption isotherm at 20°C |
|
| Chemical Structure |
|
| Osmolality |
|
| Average molecular weight | 182.2 g/mol |
| Maximal Water content (LOD) | 0.50 |
| Solubility | Very soluble in water (216 mg/ml of water at 25 °C), practically insoluble in ethanol. |
| Minimum melting temperature | 165 °C |
| Maximum melting temperature | 170 °C |
| Glass Transition Temperature of the Cryo-Concentrated Phase | -29.30 |