Soybean phospholipids and Egg yolk lecithin,AIK_specification/price/image

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Inspection items		Standard regulations	Product Description
			PC50	PC60	PC70	PC75	PC90
Appearance color		Yellow to Brown	Yellow to Brown
Odor		Has a unique odor of phospholipids and no peculiar smell	Has a unique odor of phospholipids and no peculiar smell
Trait		Viscous liquid, paste like, powder like, granular or block like	Viscous liquid, paste like, powder like, granular or block like
Phosphatidylcholine(PC)，w/%		/	≥50	≥57	≥69	≥75	≥87
Acetone Insoluble Content ，w/%		≥60	≥90
Loss on drying，w/%		≤2.0	≤2.0
N-hexane insoluble substance，w/%		≤0.3	≤0.3
Acid value,mgKOH/g		≤36.0	≤36.0
Peroxide Value/(mmol/kg)		≤5.0	≤5.0
Residual solvent	Ethanol residue，％	≤0.2	≤0.2
	Acetone residue，％	≤0.2	≤0.2
	Residual ether，％	≤0.2	≤0.2
	Petroleum ether residue，％	≤0.05	≤0.05
	Residual n-hexane，％	≤0.02	≤0.02
	Total residual solvents，％	≤0.5	≤0.5
Note: 1) Implementation standards: PC and Residual solvents refer to "Chinese Pharmacopoeia Soybean Phospholipids [8030-76-0]", and other inspection items refer to "National Food Safety Standard Food Additive Phospholipids" GB1886.358-2022 or customer agreement standards; 2) Packaging specifications: 1KG/bag, 5KG/bag, 7.5 KG/bag or packaging according to customer requirements; 3) Storage conditions: sealed, away from light, stored at low temperature (below -18 ℃); 4) Validity period: 12 months.

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Soybean phospholipid (medicinal grade):

Inspection items				Standard regulations	Product Description
					PC50	PC60	PC70
Trait	Appearance and characteristics			This product is a semi-solid, block like substance of Yellow to Brown, which is soluble in ether or ethanol and insoluble in acetone.	This product is a semi-solid, block like substance of Yellow to Brown, which is soluble in ether or ethanol and insoluble in acetone.
	Acid value, mgKOH/g			≤30	≤25
	Iodine value, gI/100g			≥75	≥80
	Peroxide Value，meq/kg			≤3.0	≤3.0
Identify	⑴ Chemical reaction			Positive reaction	Positive reaction
	⑵ Chemical reactions			Positive reaction	Positive reaction
Detection	Color of the solution (absorbance at 350nm wavelength)			≤0.8	≤0.7
	Acetone Insoluble Content ，w/%			≥90.0	≥90.0
	Hexane insoluble substance, w/%			≤0.3	≤0.3
	water content, w/%			≤1.5	≤1.5
	Heavy metals, w/%			≤0.002	≤0.001
	Arsenic salts, w/%			≤0.0002	≤0.0002
	Lead, w/%			≤0.0002	≤0.0002
	Residual solvent	Ethanol, w/%		≤0.2	≤0.2
		Acetone, w/%		≤0.2	≤0.2
		Ether, w/%		≤0.2	≤0.2
		Petroleum ether, w/%		≤0.05	≤0.05
		N-hexane, w/%		≤0.02	≤0.02
		Total Resident Solution, w/%		≤0.5	≤0.4
	microbial limit	Total aerobic bacteria count cfu/g		≤10²	≤10²
		Total number of mold and yeast cfu/g		≤10²	≤10²
		Escherichia coli/g		not detectable	not detectable
		Salmonella/10g		not detectable	not detectable
Content determination (based on anhydrous substance)	Phosphorus content, w/%			≥2.7	≥2.7
	Nitrogen content, w/%			1.5～2.0	1.5～2.0
	PC and PE content		PC，w/%	≥45.0	≥50.0	≥57.0	≥68.0
			PE，w/%	≤30.0	≤30.0
			PC+PE，w/%	≥70	≥70	≥70	≥75
Note: 1) Implementation standard: "Chinese Pharmacopoeia Soybean Phospholipids [8030-76-0]"; 2) Packaging specifications: 1KG/bag, 5KG/bag, 7.5 KG/bag or packaging according to customer requirements; 3) Storage conditions: sealed, away from light, stored at low temperature (below -18 ℃); 4) Validity period: 12 months 。

3，

Soybean phospholipids (for injection):

Inspection items				Standard regulations	Product Description
					PC70	PC80	PC90
Trait	Appearance and characteristics			This product is a semi-solid, block like substance of Yellow to Brown. This product is soluble in ether or ethanol and insoluble in acetone.	This product is a semi-solid, block like substance of Yellow to Brown. This product is soluble in ether or ethanol and insoluble in acetone.
	Acid value, mgKOH/g			≤30	≤15
	Iodine value, gI/100g			≥75	85-110
	Peroxide Value，meq/kg			≤3.0	≤3.0
Identify	⑴ Chemical reaction			Immediately produce white precipitate	Compliance
	⑵ Chemical reactions			Immediately generate brick red sediment	Compliance
	⑶ Liquid phase diagram			In the chromatogram recorded under the content determination items of phosphatidylcholine (PC) and phosphatidylethanolamine (PE), the retention time of the main peak of the test solution should be consistent with that of the reference solution.	Compliance
Detection	Color of the solution (absorbance at 350nm wavelength)			≤0.8	≤0.7
	Acetone Insoluble Content ，w/%			≥90.0	≥90.0
	Hexane insoluble substance, w/%			≤0.3	≤0.3
	water content, w/%			≤1.5	≤1.5
	protein			The solution should not be blue purple or reddish purple in color	Compliance
	Heavy metals, w/%			≤0.0005	≤0.0005
	Arsenic salts, w/%			≤0.0002	≤0.0002
	Lead, w/%			≤0.0002	≤0.0002
	Residual solvent		Ethanol, w/%	≤0.2	≤0.2
			Acetone, w/%	≤0.2	≤0.2
			Ether, w/%	≤0.2	≤0.2
			Petroleum ether, w/%	≤0.05	≤0.05
			N-hexane, w/%	≤0.02	≤0.02
			Total Resident Solution, w/%	≤0.5	≤0.4
	Regarding substances		LPE，w/%	≤1	≤1
			LPC，w/%	≤3.5	≤3.5
			LPC+LPE，w/%	≤4.0	≤4.0
			PI，w/%	≤5.0	≤5.0
			Total related substances, w/%	≤8.0	≤8.0
	microbial limit		Total aerobic bacteria count cfu/g	≤10²	≤10²
			Total number of mold and yeast cfu/g	≤10²	≤10²
			Escherichia coli/g	not detectable	not detectable
			Salmonella/10g	not detectable	not detectable
	Bacterial endotoxins, EU/g			＜2.0	＜2.0
Content determination (based on anhydrous substance)	Phosphorus content, w/%			≥2.7	≥3.3
	Nitrogen content, w/%			1.5～2.0	1.5～2.0
	PC、PE content	PC，w/%		≥45.0	≥70.0	≥78.0	≥88.0
		PE，w/%		≤30.0	≤18.0
		PC+PE，w/%		≥70	≥75	≥80	≥90
Note: 1) Implementation standard: "Chinese Pharmacopoeia Soybean Phospholipids (for Injection) [8030-76-0]"; 2) Packaging specifications: 1KG/bag, 5KG/bag, 7.5 KG/bag or packaging according to customer requirements; 3) Storage conditions: sealed, away from light, stored at low temperature (below -18 ℃); 4) Validity period: 24 months.

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Egg yolk lecithin (for injection):

Inspection items			Standard regulations	Product Description
				PC70	PC80
Trait	Appearance		This product is a milky white or light yellow powder or waxy solid with a slight distinctive odor. This product is soluble in ethanol, ether, chloroform, or petroleum ether (boiling range 40-60 ℃), and is almost insoluble in acetone and water.	This product is a milky white or light yellow powder or waxy solid with a slight distinctive odor. This product is soluble in ethanol, ether, chloroform, or petroleum ether (boiling range 40-60 ℃), and is almost insoluble in acetone and water.
	Acid value, mgKOH/g		≤20.0	≤15.0
	Saponification value, mgKOH/g		195～212	195～212
	Iodine value, gI/100g		60～73	63～73
	Peroxide Value，meq/kg		≤3.0	≤2.0
Identify	chemical reaction		The generated gas can turn wet red litmus paper blue	Compliance
	chemical reaction		Should be yellow green in color	Compliance
	Liquid phase diagram		In the chromatogram recorded under the content determination items of phosphatidylcholine (PC) and phosphatidylethanolamine (PE), the retention time of the main peak of the test solution should be consistent with that of the reference solution.	Compliance
Detection	Free fatty acids, w/%		≤1	≤1
	Triglycerides, w/%		≤3	≤3
	cholesterol, w/%		≤2	≤2
	Palmitic acid, w/%		≤0.2	≤0.2
	Regarding substances	PI，w/%	≤5.0	≤5.0
		LPE，w/%	≤1	≤1
		SPM，w/%	≤3.0	≤3.0
		LPC，w/%	≤3.5	≤3.5
		LPC+LPE，w/%	≤4.0	≤4.0
		Including the total amount of the above-mentioned substances, w/%	≤8.0	≤8.0
	Residual solvent	Ethanol, w/%	≤0.2	≤0.2
		Acetone, w/%	≤0.2	≤0.2
		Ether, w/%	≤0.2	≤0.2
		Petroleum ether, w/%	≤0.05	≤0.05
		N-hexane, w/%	≤0.02	≤0.02
		Total Resident Solution, w/%	≤0.5	≤0.5
	water content, w/%		≤3	≤1.5
	protein		The solution should not be blue purple or reddish purple in color	Compliance
	Heavy metals, w/%		≤0.0005	≤0.0005
	Arsenic salts, w/%		≤0.0002	≤0.0002
	Bacterial endotoxin EU/g		＜2.0	＜2.0
	microbial limit	Total aerobic bacteria count cfu/g	≤10²	≤10²
		Mold and yeast cfu/g	≤10²	≤10²
		Escherichia coli/g	not detectable	not detectable
		Salmonella/10g	not detectable	not detectable
Content determination (calculated as anhydrous substance)	Phosphorus content, w/%		3.5～4.1	3.5～4.1
	Nitrogen content, w/%		1.75～1.95	1.75～1.95
	PC、PE content	PC，w/%	≥68.0	≥68.0	≥75.0
		PE，w/%	≤20.0	≤20.0	≤15.0
		PC+PE，w/%	≥80	≥80	≥80
Note: 1) Implementation standard: "Chinese Pharmacopoeia Egg Yolk Phosphatidylcholine (for Injection) [93685-90-6]"; 2) Packaging specifications: 1KG/bag, 5KG/bag, 7.5 KG/bag or packaging according to customer requirements; 3) Storage conditions: sealed, away from light, stored at low temperature (below -18 ℃); 4) Validity period: 24 months.