Cholesterol(Plant Origin)
Chemical Structural Formula:
Specifications of Plant-Based Cholesterol:
Test Items | Specifications | Test Methods |
Appearance | White powder or flake crystal | Visual |
Identification | Complies with the reference substance structure | IR |
Complies with the reference substance structure | TLC | |
Passes the test | Color Reaction A | |
Passes the test | Color Reaction B | |
Solubility | This product is easily soluble in chloroform, dissolved in ether, slightly soluble in acetone, ethyl acetate, slightly soluble in ethanol, insoluble in water | Pharmacopoeia examples |
Residue on Ignition | Not more than 0.1% | ChP<0841> |
Acid Value | Not more than 0.3ml | Titration Method |
Purity | Not less than 98.0% | HPLC |
Assay | 95.0% ~ 115.0% | HPLC |
Specific Rotation | -34.0° ~ -38.0° | ChP<0621> |
Loss on Drying | Not more than 0.3% | ChP<0831> |
Melting Range | 147℃ ~ 150℃ | ChP<0612> |
Peroxide Content | Not more than 6.0% | ChP<0713> |
Residual Solvents | Not more than 0.5% | GC |
Endotoxin | Not more than 0.1 EU/mg | ChP<1143> |
Bacteriological Data | TAMC/g: Not more than 100CFU/g | ChP<1105> |
TYMC/g: Not more than 10CFU/g | ||
Elemental Impurities | Not more than 10ppm | ChP<0821> |
Arsonium Salt | Not more than 0.0002% | ChP<0822> |
Nickel(Ni) | Not more than 1ppm | ChP<0412> |
Ethanol Insoluble Matter | Must not be sedimented or cloudy | Visual |
Moisture | Not more than 1.0% | KF |
Application:
Used as one of the LNP Delivery System Excipients for mRNA medicines or drugs
Packaging:
1g/bottle, 5g/bottle or according to the requirements from customers.
Recommended Storage Conditions:
Kept at -20 ± 5℃ under an inert atmosphere.
To reduce the moisture absorption, it should be slowly warmed to ambient temperature before opened.
Shelf Life:
24 months if stored under above conditions.