D-Sucrose
USP,EP,Injectable Grade
CAS #:
57-50-1
Molecular Formula:
C12H22O11
Synonym:
β-D-Fructofuranosyl α-D-glucopyranoside
Molecular Weight:
342.30 g/mol
Overview
Sucrose is used in medications to impart a more pleasant taste to often unpalatable chemicals and can be found in many medical dosage forms including chewable tablets, syrups, lozenges, or gums. It is a white odourless crystalline solid, a non-reducing disaccharide composed of glucose and fructose. It is obtained commercially from sugar cane, sugar beet and used extensively as a food and a sweetener
| Characters | Unit | Specification |
|---|---|---|
| Identity (EP<2.2.24>) (USP<197K>) | IR | |
| Identity (EP<2.2.27>) | TLC | |
| Identity (EP) | Orange ppt. formed | |
| Appearance | White microcryst. solid | |
| Solubility | EP | |
| Appearance of solution (EP) (USP) | Clear <2.2.1> | |
| Conductivity (EP<2.2.38>) (USP) | µScm-1 | ≤ 35 µScm-1 |
| Color (EP) (USP) | ≤ 45 | |
| Assay | % | ≥ 99 % (typically > 99.5%) |
| Sp. Rot., [α]D (EP<2.2.7>) (USP<781S>) | o | +66.3º to +67.0º |
| LOD (EP<2.2.32>) (USP<731>) | % | ≤ 0.1 |
| Moisture (K. F.) | % | ≤ 0.1 |
| Dextrin | EP; USP | |
| Reducing Sugars | EP; USP | |
| Sulfite (SO2) (EP) | ppm | ≤ 10 |
| Sulfite (SO2) | USP | |
| Microbiological Specifications | ||
| Total Aerobic Plate Count | CFU/g | ≤ 100 |
| E. Coli | Negative | |
| Salmonella | Negative | |
| Staphylococcus aureus | CFU/g | Negative, ≤ 10 |
| Pseudomonas | CFU/g | Negative, ≤ 10 |
| Mold and Yeast | CFU/g | ≤ 100 |
| Bacterial Endotoxins*(EP <2.6.14>)(USP<85>) | IU/mg | ≤ 0.25 |
| *If intended for use in the manufacture of large-volume parenteral preparations. | ||
Shelf Life/Retest Date: The minimal shelf-life of D-Sucrose, CAS 57-50-1 is 2 years when stored under recommended conditions.
Storage/Shipping Conditions:
- Keep container tightly closed in a dry and well-ventilated place.
Pack Sizes: 5 Kg
