PEARLITOL® 200 INH
Mannitol
| Product Name | PEARLITOL® 200 INH |
| Generic Name | Mannitol for Inhalation DPI |
| Physico-chemical properties | |
| Compliance | EP/USP-NF/JP/IP/CHP |
| Synonyms | D-Mannitol |
| CAS Number | 69-65-8 |
| Chemical Structure |
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| Average Molecular Weight | 182.2 g/mol |
| Physical Form or Appearence | White or almost white crystalline powder |
| Application | PEARLITOL® 200 INH mannitol for inhalation has outstanding particle size distribution and particle morphology making it an appropriate carrier for DPI (dry powder inhalers). It offers high API compatibility (no Maillard reaction thanks to the low content of reducing sugars) and no hygroscopicity, ensuring reliable and efficient drug delivery without the need for stringent handling or storage requirements. |
| Water content (LOD) |
Water Content (LOD) Maximum: 0.5 % |
| Morphology |
|
| Average mean particle diameter | 150 µm |
| Particle Size Distribution by Laser Diffraction |
dv10: max. 100 µm dv50: 120 - 180 µm dv90: max. 280 µm |
| Solubility | Freely soluble in water (1 part in 5.5 part of water at 20°C), sparingly soluble in 95% ethanol (1 part in 83), practically insoluble in ether |
| Melting temperature |
Minimum melting temperature : 165 °C Maximum melting temperature: 170 °C |
| Water sorption isotherm at 20°C |
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| Powder Characteristics |
Powder Flowability (according to Ph.Eur. 2.9.16, 10mm outflow opening): 6 s Tapped Density: 0.57 g/cm3 True Density: 1.514 g/cm3 Specific surface area: 1.2 m2/g Bulk Density: 0.48 g/cm3 |
| Microbial specifications | TAMC: 100 CFU/g max. TYMC: 10 CFU/g max. E. coli: not detected in 1 g Salmonella: not detected in 10 g Pseudomonas aeruginosa: not detected in 1 g Bile tolerant gram-negative: not detected in 1 g Staphylococcus aureus: not detected in 1 g
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