D-Mannitol
USP, EP, Injectable Grade
CAS #:
69-65-8
Molecular Formula:
C6H14O6
Synonym:
Mannite
Molecular Weight:
182.17 g/mol
Overview
D-Mannitol, Powder, USP, EP, Injectable grade is a diuretic used to increase urine production. D-Mannitol is also known as mannite or manna sugar. It is used to relieve osmotic stress in plants and used clinically in osmotherapy. It is classified as a sugar alcohol and is most commonly observed in its white crystalline solid form. It has several uses, ranging from inducing osmotic stress in plants to being used to produce tablets of medicine. It can also be added to boric acid to increase the strength of the acid in order to allow for a better degree of accuracy in volumetric analysis of the acid.
| 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 | °C | 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 |
| Heavy metals (Pb) (EP) | ppm | ≤ 5 |
| Ni (EP<2.4.15>) (AAS : USP<852>) | ppm | ≤ 1.0 |
| Microbiological Specifications | ||
| Total Aerobic (EP<2.6.12>) (USP<62>) | CFU/g | ≤ 100 |
| E Coli | Negative | |
| Salmonella | Negative | |
| Staphylococcus aureus | Negative | |
| Pseudomonas | Negative | |
| Mold and Yeast (EP<2.6.13>) (USP<62>) | CFU/g | ≤100 |
| 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, 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 at ambient temperature.
- Transport in an ambient temperature.
Pack Sizes: 5 Kg
