D-Mannitol (Sterile) is used as an osmotic diuretic, as a diagnostic agent for kidney function, as an adjunct in the treatment of acute renal failure, and as an agent to reduce intracranial pressure, treat cerebral edema, and reduce intraocular pressure.
Characters | Unit | Specification |
---|---|---|
Identity (EP<2.2.24>) (USP<197k>) | IR | |
Identity (EP<2.2.27>) | TLC | |
Identity (EP<2.2.7>) | Sp. Rot., [α]D: +23° to 25° | |
Identity (EP<2.2.14>) (USP<741>) | °C | MP: 165-170 °C |
Appearance | White microcryst. solid | |
Solubility | Freely soluble in water, practically insoluble in Ethanol (96%) | |
Appearance of solution (EP) (USP) | Clear (2.2.1), colorless (2.2.2, Method II) solution | |
Conductivity (EP<2.2.38>) (USP) | 20 pScm-1 | |
Assay (EP<2.2.29>) (USP) | % | 97 - 102 |
Related Substances (EP<2.2.29>) (USP) | ||
Impurity A (D-Sorbitol) | % | ≤ 2 |
Impurity B (D-Malttitol) +Impurity C (Isomalt) | % | ≤ 2 |
Unknown impurities | % | ≤ 0.1 |
Total impurities | % | ≤ 2 |
Reducing Sugars | USP, EP | |
LOD (EP<2.2.32>) (USP<731>) | % | 0.5 |
Residual Solvents (USP) | Meets USP <467> specifications | |
Bulk Density (USP<616>) | Report Results | |
Tap Density (USP<616>) | Report Results | |
Heavy metals (Pb) (EP) | ppm | ≤ 5 |
Ni (EP<2.4.15>) (AAS : USP<852>) | ppm | ≤ 1.0 |
Sterility Test (USP<71>) | No growth observed after 14 days at 30-35 °C | |
E Coli | Negative | |
Salmonella | Negative | |
Staphylococcus aureus | Negative | |
Pseudomonas | Negative | |
Endotoxin Level+ (EP <2.6.14>)(USP<85>)* | IU/g | ≤ 4 |
Endotoxin Level+ (EP <2.6.14>) (USP<85›)** | IU/g | ≤ 2.5 |
+If intended for use in the manufacture of parenteral dosage forms without a further appropriate procedure for the removal of bacterial endotoxins. | ||
* - For parenteral dosage forms having a concentration of 100 WI. or less of Mannitol | ||
** - For parenteral dosage forms having a concentration of more than 100 of Mannitol. |
Shelf Life/Retest Date: The minimal shelf-life of D-Mannitol (Sterile) CAS 69-65-8 is 2 years when stored under recommended conditions.
Storage/Shipping Conditions:
Pack Sizes: 5 Kg