D-(+)- Mannitol, Sterile
USP,EP,Injectable Grade
CAS #:
69-65-8
Molecular Formula:
C6H14O6
Synonym:
Mannite
Molecular Weight:
182.17 g/mol
Overview
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.
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| 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:
- Keep container tightly closed in a dry and well-ventilated place.
- Keep in a dry place.
- Storage class (TRGS 510): Non-combustible solids.
Pack Sizes: 5 Kg
