Mannitol is a sugar alcohol commonly used in the pharmaceutical industry for various purposes.
CAS No. :
87-78-5EINECS :
201-770-2Package :
25KG/BAGBrand :
TOPINCHEM®Origin :
CHINAFormula :
C6H14O6Minimum Order :
1000KGItem :
Mannitol
Description
Mannitol is a white, crystalline powder with a sweet taste and is known for its ability to act as an osmotic diuretic. Mannitol finds applications in pharmaceuticals due to its unique properties, including solubility, stability, and low toxicity.
Specification
| Items | Standard | Test Result | |
| Appearance | White or almost white | Conforms | |
| crystals or powder | |||
| Solubility | Freely soluble in water | Conforms | |
| practically insoluble in | |||
| ethanol(96 per cent) | |||
| Specific Optical Rotation | +23~25° | +24.1° | |
| Identification | Melting Point | 165.0℃~170.0℃ | 166.1℃~167.1℃ |
| Infrared Absorption | Conforms | Conforms | |
| Appearance of Solution | Clear and Colorless | Conforms | |
| Conductivity | ≤20μS/cm | 1.5μS/cm | |
| Reducing Sugars | ≤0.1% | <0.1% | |
| A(sorbitol) | ≤2.0% | 0.64% | |
| Related | |||
| Substances | B+C(Maltitol+Isomalt | ≤2.0% | 0.00% |
| (Disregards Limit ≤0.05%) | Unspecified | ≤0.1% | 0.00% |
| Total | ≤2.0% | 0.64% | |
| Nickel | ≤1ppm | <1ppm | |
| Heavy Metals | ≤5ppm | <5ppm | |
| Loss on Drying | ≤0.5% | 0.14% | |
| TAM C | ≤10³cfu/g | <10cfu/g | |
| Microbiological | TY MC | ≤10²cfu/g | <10cfu/g |
| E.Coli | Negative | Negative | |
| Salmonella | Negative | Negative | |
| Bacterial Endotoxins | ≤2.5EU/g | <2.5EU/g | |
| Assay | 97.0%~102% | 99.40% | |
| Conform with BP/USP/EP Requirements | |||
Application
Pharma grade excipient Mannitol is a sugar alcohol commonly used in pharmacy for various purposes. Some of its important functions include:
Tablet Formulations: Mannitol serves as a diluent and afiller, contributing to the physical properties of thetablet, such as hardness and disintegration.
Osmotic Diuretic: Used in medical settings, particularlyfor the reduction of intracranial pressure and theprevention of acute renal failure. lts osmotic propertiespromote the removal of excess fluid from tissues.
Lyoprotectant for Proteins and Vaccines: Utilized as alyoprotectant in the freeze-drying (lyophilization)process of pharmaceuticals, especially for proteins andvaccines.lt helps maintain the stability and activity ofthese sensitive compounds during storage.
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