Pharmaceutical Grade Mixed Fatty Acid Glycerides 36 20kg Pharmacopoeia Standard

Pharmaceutical Grade Mixed Fatty Acid Glycerides 36 20kg Pharmacopoeia Standard This product is a mixture of mono-, di- and tri-glycerides of C8~C18 saturated fatty acids
.

【Properties】This product is a white or off-white waxy solid; it has a greasy odor
.

This product is easily soluble in or in, soluble in petroleum ether (60~90℃), almost insoluble in water or ethanol
.

Melting point The melting point of this product (general rule 0612 second method) is: 34 type 33~35℃; 36 type 35~37℃; 38 type 37~39℃; 40 type 39~41℃
.

Acid value The acid value of this product (general rule 0713) should not be greater than 1.
0
.

Hydroxyl Value The hydroxyl value of this product (General Rule 0713) should not be greater than 60
.

Iodine value The iodine value of this product (general rule 0713) should not be greater than 2.
0
.

Peroxidation value The peroxide value of this product (general rule 0713) is not greater than 3
.

　　Saponification value The marked saponification value of this product should be 215~260, and the saponification value (general rule 0713) should be 95%~105% of the marked saponification value
.

　　[Identification] Take about 1.
0g of this product, add 10ml to dissolve it, and use it as the test solution
.

According to the thin-layer chromatography (general rule 0502) test, draw 5 μl of the solution to be tested, point it on a silica gel G thin-layer plate, use acetone (20:0.
5) as the developing agent, develop, the developing distance should be greater than 12cm, air dry, and place Immediately after color development in iodine vapor, there should be at least four spots
.

　　[Check] Take 2.
0g of this product for basic impurities, add 1.
5ml and 3.
0ml of ethanol to dissolve, heat and dissolve in a 40°C water bath, add 0.
05ml of bromophenol blue indicator solution, and use hydrochloric acid titration solution (0.
01mol/L) Titrate until the solution turns yellow, and the volume of the hydrochloric acid titrant (0.
01mol/L) consumed should not exceed 0.
15ml
.

　　Ash content Take this product and inspect it according to the law (General Rule 2302), and the remaining residue shall not exceed 0.
05%
.

　　Take 1g of this product for heavy metals, add 20ml of saturated sodium chloride solution, heat and dissolve in a water bath, then cool in an ice bath, filter, transfer the filtrate to a 50ml Nessler colorimetric tube, add 2ml of dilute acetic acid and an appropriate amount of water to make it 25ml, inspected in accordance with the law (the first method of general rule 0821), and the heavy metal content shall not exceed 10 parts per million
.

　　【Category】Pharmaceutical excipients, suppository bases and release blockers,
etc.