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Medicinal grade corn oil use properties oil excipients; Solvents; Viscosative.
Corn oil is mainly used as a solvent for intramuscular injection preparations or as excipients for topical preparations
.
Emulsions containing up to 67% corn oil are also used as oral nutritional supplements
.
When combined with surfactants and polymers that can form gels, it can be used as veterinary vaccine preparations
.
Corn oil as a cooking oil has a long history, but also used in oral administration of tablets or capsules in the [inspection] non-saponification 5.
0g of this product, measured according to law (general 0713), non-saponification shall not exceed 1.
5%.
Sterol composition (for injection) Take the solution titrated to the end point by ethanol to sodium hydroxide titration solution (0.
1mol/L) under the non-saponified substance, determine according to law (general rule 0713), calculate according to the area normalization method, and the rapeseed sterol in the test product shall not exceed 0.
3%.
Alkaline impurities Take this product, determine according to law (general 0713), consume the volume of hydrochloric acid titration solution (0.
01mol/L) shall not exceed 0.
1ml
.
Methoxyaniline value (for injection) Take 2.
0g of this product, measured according to law (general 0713), methoxyaniline value should not be greater than 8.
0
.
Moisture shall not exceed 0.
1% (General 0832, Act 1 2
).
Heavy metals Take 1.
0g of this product, check according to law (General Principle 0821 Second Law), and contain heavy metals shall not exceed 10 parts
per million.
Fatty acid composition is taken from the test product 0.
1g, determined according to law (general rules 0713); respectively, take methyl myristate, methyl palmitate, methyl palmitate, methyl stearate, methyl oleate, methyl linoleate, methyl linoleate, methyl arachidate, methyl eicosalate, methyl eicosaenoate, methyl behexanoate, methyl docosaenoate, methyl tetracosaenate, add n-heptane to dissolve and dilute to make a solution containing about 0.
1 mg per 1ml, as a
。
According to the area normalization method, saturated fatty acids containing less than fourteen carbon should not exceed 0.
1%, myristic acid should not exceed 0.
1%, palmitic acid should be 8.
6% to 16.
5%, palmoleic acid should not exceed 0.
5%, stearic acid should be 1.
0% to 3.
3%, oleic acid should be 20.
0% to 42.
0%, linoleic acid should be 39.
4% to 62.
0%, linolenic acid should be 0.
5% to 1.
5%, and peanut acid should not exceed 0.
8%.
Eicosaenoic acid shall not exceed 0.
5%, beemic acid shall not exceed 0.
3%, docosaenoic acid shall not exceed 0.
1%, and tetracosanoic acid shall not exceed 0.
4%.
Microbiological limits Take this product, check according to law (General Principle 1105 and General Principle 1106), the total number of aerobic bacteria in each 1ml of the test product shall not exceed 102cfu, the total number of mold and yeast shall not exceed 102cfu, and Escherichia
coli shall not be detected.
Disodium edetate Pharmaceutical grade excipients comply with the 2020 Pharmacopoeia Part IV Injection Grade Shanxi Jinyang Excipient Triethyl Citrate Pharmaceutical Grade Excipients 2020 Pharmacopoeia has a registration certificate quality inspection certificate Shanxi Jinyang Excipient Insect White Wax Granules Pharmacopeia Filing 500g 5kg CDE Filing Quality Inspection Single Business License Shanxi Jinyang Excipient sorbitol 1kg 5kg Pharmacopoeia Filing Qualification Full CDE Filing Quality Inspection Single Business License Shanxi Jinyang Excipient Potassium Dihydrogen Phosphate 500g 25kg 2020 Pharmacopoeia Filing Shanxi Jinyang excipient sodium thiosulfate 1kg 25kg Shanxi Jinyang excipient sodium chloride 1kg Shanxi Jinyang excipient CDE record quality inspection single business license zinc sulfate consumption number 500g 25kg Shanxi Jinyang excipient