Sodium Stearate
Brief Introduction:
Sodium stearate is an organic compound with the chemical formula C17H35COONa, a white oily powder with a greasy feeling and a fatty smell. Soluble in hot water or hot alcohol. The aqueous solution is alkaline due to hydrolysis, and the alcoholic solution is neutral. It is produced by the interaction of octadecanoic acid and sodium hydroxide. Used in toothpaste manufacturing, also used as waterproofing agent, plastic stabilizer and pharmaceutical excipient.
Specifications of our Pharmaceutical Grade Sodium Stearate:
Test Items | Specifications | |
USP Standard | EP Standard | |
Characteristics | / | This product is white to slightly yellow powder, with a greasy feeling when in contact with the skin, slightly soluble in water or ethanol. |
Identification 1: Freezing point of fatty acids, °C | / | ≥53 (Identification A) |
Identification 2: Identification of fatty acids | The retention time of the two main peaks of the test solution should be consistent with the retention time of the two main peaks of the reference solution. (Identification B) | The retention time of the two main peaks of the test solution should be consistent with the retention time of the two main peaks of the reference solution. (Identification C) |
Identification 3: Sodium Salt Identification | Should be positive (Identification A) | Should be positive (Identification D) |
Acidity (as Stearic Acid), % | 0.28 ~ 1.20 | 0.8 ~ 1.2 |
Fatty acid value | 196 ~ 211 | 195 ~ 210 |
Fatty acid iodine value | ≤4.0 | / |
Loss on drying, % | ≤5.0 | ≤5.0 |
Chloride,% | / | ≤2.0 |
Sulphate, % | / | ≤3.0 |
Ethanol insoluble matter | / | / |
Nickel(Ni), ppm | / | ≤5 |
Relative content of stearic acid, % | ≥40 | ≥40 |
The sum of the relative content of stearic acid and palmitic acid, % | ≥90 | ≥90 |
Sodium content(Calculated on the anhydrous basis), % | / | 7.4 ~ 8.5 |
Total number of aerobic bacteria, CFU/g | / | ≤1000 |
Total number of moulds and yeasts, CFU/g | / | ≤100 |
Escherichia coli, g | / | Negative |
Salmonella, 10g | / | Negative |
The Application of Sodium Stearate in the Field of Medicine:
♔ Sodium stearate can be used as a drug carrier to help drugs be better absorbed and utilized. Sodium stearate also acts as a lubricant to help reduce friction and wear on the medication, thereby extending the life of the medication.
♔ Sodium stearate can also be used to prepare lubricants for surgical instruments, belonging to the technical field of medical instrument lubricants.
Specifically, sodium stearate is used as the main component of lubricants on surgical instruments, which has excellent lubricity, adsorption and rust resistance, it can lubricate and protect medical devices well, and has a remarkable effect in reducing the frictional resistance generated during the closing and firing process.
Packaging:
Woven bag for external use, lined with high-pressure polyethylene film bag, net weight 25kg; can also be packed according to the specific requirements from customers.
Storage Conditions:
Preserved in unopened original containers in a cool dry and ventilated place before using; kept away from direct sunlight, heat and moisture.
Shelf Life:
24 months if stored under above conditions.