D-(+)-Trehalose Dihydrate
USP,EP,Injectable Grade
CAS #:
6138-23-4
Molecular Formula:
C12H22O11 . 2H2O
Synonym:
α,α-TREHALOSE; α-D-GLUCOPYRANOSYL-α-D-GLUCOPYRANOSIDE
Molecular Weight:
378.33 g/mol
Overview
D-(+)-Trehalose, Dihydrate, is a natural alpha-linked disaccharide that is also referred to as mycose or tremalose. It is found naturally in plants and microorganisms such as grasshoppers, shrimp, butterflies and bees. It is thought to have a use in the treatment for Huntington's and Parkinson's disease as it possibly corrects defects in autophagy seen in these diseases.
| Characters | Unit | Specification |
|---|---|---|
| Appearance | White microcryst. solid | |
| Solubility | Freely soluble in water, slightly soluble in MeOH, practically insoluble in EtOH (96%) | |
| Identity A (EP <2.2.24>) | IR | |
| Identity B | Violet color develops | |
| Identity C | No brown color develops | |
| Appearance of Solution | Solution S is clear (EP <2.2.1>) and colorless (EP <2.2.2, Method II>) | |
| pH (EP <2.2.3>) | 4.5-6.5 | |
| Sp. Rot., [α]D (EP <2.2.7>) | o | +197-+201° (anhydrous) |
| Heavy Metals (EP <2.4.8>) | ppm | ≤ 5 |
| Chlorides (EP <2.4.4>) | ppm | ≤ 125 |
| Sulfates (EP <2.4.13>) | ppm | ppm ≤ 200 |
| Soluble Starch (EP) | No blue color develops | |
| Water (EP <2.5.12>) | % | 9-11% |
| Assay (EP <2.2.29>) | % | ≥ 99 |
| Impurity A (Glucose) | % | ≤ 0.5 |
| Impurity B (Oligosaccharides) | % | ≤ 0.5 |
| Unspecified Impurities | ||
| (EP <2.2.29>) | % | ≤ 0.2 (each) |
| Total Impurities (EP <2.2.29>) | % | ≤ 1 (each) |
| Residual Solvents | ||
| MeOH | ppm | < 3,000 |
| EtOH | ppm | < 5,000 |
| Methyl Isobutyl Ketone | ppm | < 5,000 |
| Sulfated Ash (EP <2.4.13>) | % | ≤ 0.1 |
| Microbiological Specification | ||
| Total Aerobic (EP <2.6.12>) | CFU/g | ≤ 100 |
| E. Coli (EP <2.6.13>) | negative | |
| Salmonella (EP <2.6.13>) | negative | |
| Mold and Yeast (EP <2.6.12>) | CFU/g | ≤100 |
| Endotoxin Level (EP <2.6.14>) | EU/ mg | ≤ 2.5 |
Shelf Life/Retest Date: The minimal shelf-life of D-(+)-Trehalose Dihydrate CAS 6138-23-4 is 2 years when stored under recommended conditions.
Storage/Shipping Conditions:
- Keep container tightly closed in a dry and well-ventilated place.
- Store at room temperature in the original container.
- Store away from incompatible materials.
Pack Sizes: 5 Kg
