Luteolin HPLC 98% factory
Product Name: Luteolin
Latin name:Arachis hypogaea L
Quality standard:CP2015&US CHROMADEX
Test method: HPLC
CAS NO: 491-70-3
Appearance: Light yellow powder
Storage method: The product should be sealed and stored in a cool and dry place.
Shelf life: 24month when properly stored.
Source of extraction: Sophora japonica
Package specification: 1kg / aluminum foil bag, 25kg/Drum or as required by customers
Product introduction:luteolin is slightly soluble in water, weakly acidic, soluble in alkaline solution, stable under normal conditions.
This technical requirement specifies the technical requirements, test method, test rules and label of luteolin.
The requirements of this standard are applicable to products made from rutin by reduction and semi-synthesis of safety powder.
2.Standardization of reference document
The terms in the following documents become terms of this technical requirement by reference to them.All subsequent amendments (excluding errata) or revisions to dated references shall not apply to this Technical Requirement; however, the parties to an agreement under this Technical Requirement are encouraged to study the availability of the latest version of these documents.For undated references, the latest version is applicable to this technical requirement.
GB/T 5009.11 Determination of total arsenic and inorganic arsenic in food
GB/T 5009.12 Determination of lead in foods
GB/T 5009.15 Determination of cadmium in foods
GB/T 5009.17 Determination of total and organic mercury in foodstuffs
GB/T 5009.19 Determination of multi – component residues of organochlorine pesticides in food
GB 4789.2 Microbiological testing of food hygiene – determination of total number of colonies
GB 4789.3 Microbiological testing of food hygiene – determination of coliform bacteria
GB 4789.15 Food hygiene microbiology test for mold and yeast counts
Pharmacopoeia of the People’s Republic of China (2015 edition).
Luteolin Molecular formula C15H10O6 Molecular weight 286.24
4.1.1 Raw material For Sophora japonicae extract rutin, tablet alkali, insurance powder (sodium disulfite).
4.1.2 In the process, rutin is dissolved in alkaline water, and sodium disulfite is added for reflux hydrolysis, reduction, filtration and recrystallization.
4.2 Sensory requirement
Conform to the requirement of chart
Chart 1 sensory index
Luteolin special smell
4.3 Symbolic ingredient
Conform to chart 2 requirement
Chart 2 Symbolic ingredient
According to dry powder luteolin purity（g/100g）
More than 98.0
4.4 Physicochemical requirement
Conform to chart 3 requirement
Chart 3 Physicochemical requirement
|Partical size[80 mesh pass （%）] ≧||
|Ash content（%） ≦||
|Hexachloro-cyclohexane soprocide （mg/kg） ≦||
|DDT （mg/kg） ≦||
|Huintozene （mg/kg） ≦||
4.5 Microbiological indicator
Conform to chart 4 requirement
Chart 4 Microbiological indicators
|Total Plate Count/（cfu/g） ≦||
|Yeast & Mold/（cfu/g） ≦||
5 Test method
5.1 After opening the sample, smell its smell and taste its taste immediately;In addition, appropriate amount of the sample was placed in a white porcelain plate to observe its color and appearance, and to check for foreign bodies.
5.2 Physicochemical requirement
5.2.1 The purity of Luteolin The method was determined according to Appendix A
The test was carried out according to the screening method stipulated in the General Rule 0982(Second Method) of the Fourth Part of the Pharmacopoeia of the People’s Republic of China (2015).
The assay was conducted according to the method specified in General Rule 0832(second method) of the fourth part of Pharmacopoeia of the People’s Republic of China (2015 edition).
5.2.4 Ash content
The assay was carried out according to the method specified in General Rule 1106 of the fourth part of Pharmacopoeia of the People’s Republic of China (2015 edition)
The total arsenic and inorganic arsenic in food were determined according to GB/T 5009.11 method.
According to GB/T 5009.12 for the determination of lead in food.
Cadmium in food was determined according to GB/T 5009.15.
The total mercury and inorganic mercury in food were determined according to GB/T 5009.17.
5.2.9 Hexachloro-cyclohexane soprocide DDT Huintozene
Execute according to GB/T 5009.19
5.4 Bacteriological examination
5.4.1 Total Plate Count
In accordance with the “national food hygiene standard” GB4789.2
5.4.2 Yeast & Mold
In accordance with the “national food hygiene standard” GB4789.15
In accordance with the “national food hygiene standard” GB4789.3
In accordance with the “national food hygiene standard” GB4789.4
In accordance with the “national food hygiene standard” GB4789.10
6 Test rule
Samples were taken according to the method specified in the General Rule 0211 of the Four Parts of the Pharmacopoeia of the People’s Republic of China (2015 edition), and the products that were evenly mixed and had the same nature and quality within a certain limit were tested as the same batch.
6.2 Inspection Classification
6.2.1 Delivery inspection
Before leaving the factory, the quality inspection department of the factory shall inspect the products batch by batch according to the requirements of 4.2 ~ 4.5, and the products that pass the inspection and issue the quality certificate can be sold before leaving the factory.
6.2.2 Test type
Carry out type inspection according to chapter 4.Type inspection shall be carried out every six months in case of any of the following situations:
A) when there is a big change in raw materials;
B) Adjustment of key processes;
C) Resuming production after replacing equipment or stopping production;
D) There is a big difference between the results of ex-factory inspection and the last type inspection.
6.3 Decision rules
6.3.1 If one of the inspection results does not meet the technical requirements, samples of twice the quantity shall be randomly selected from the same batch of products for re-inspection, and the re-inspection result shall prevail.If there is still one index unqualified in the reinspection, the batch of products will be judged as unqualified.
6.3.2 If any item in the microbial project does not meet the technical requirements, it will be judged as unqualified and will not be re-inspected.
6.3.3 Determination of type inspection is the same as that of factory inspection.
Labeling, packaging, transportation and storage
7.1 The label
7.1.1 The packaging label shall mark: sample name, date of production, batch number of production, specification, gross weight, net weight and execution standard.
7.1.2 The label content is clearly visible and the label is firmly pasted.
7.2 The packing
Packaging materials should meet the requirements of food hygiene.The packaging materials shall be inspected strictly before use.After the barrel is packed, it should be sealed with a seal label.
7.3.1 The means of transport shall be clean and hygienic, and shall not be mixed with poisonous, harmful, corrosive or odor articles.
7.3.2 Light load and light discharge shall be carried out, and extrusion, exposure and rain shall be prevented during transportation.
7.4.1 The product shall not be stored mixed with toxic, harmful, corrosive or peculiar smell.
7.4.2 The product should be sealed and stored in a cool and dry place.
7.5 Shelf life
Shelf life is 24 months.
Determination of Luteolin purity
A.1 Methods The samples are extracted by ultrasonic wave and detected by high performance liquid chromatography.
A.2 Test instruments and appliances
A.2 Test instruments and appliances
A.2.1 Analytical balance, accuracy is 1/100,000th
A.2.2 Ultrasonic Cleaning Instrument: 250W, 20KHz
A.2.3 High performance liquid chromatograph
A.3 Reagents and solutions
A.3.1 Acetonitrile, analytical pure
A.3.2 Water, secondary distilled water
A.3.3 Luteolin control comparison product.
A.3.4 Preparation of mobile phase: mixed with acetonitrile-water (30:70) ratio, obtained by filtration with microporous membrane.
A.3.5 Detector and detection wavelength: UV spectrophotometer, detection wavelength 360nm.
A.4 Methods of operation
A.4.1 Preparation of reference solution: Luteolin comparison product solution (accurate to 0.01mg) was accurately weighed and added with methanol to prepare A solution containing 70μg per 1mL as comparison product solution.
A.4.2 Preparation of test solution: Take A sample of luteolin (about 10mg), weigh it accurately, dissolve it with ultrasonic methanol, and use it as the test solution.
A.4.3 Determination methods
Precisely absorb 10μl of comparison product solution and test solution, inject into liquid chromatograph, and got
A.5 Calculation of results
The purity of luteolin was calculated according to Equation (B.1) :
S1– Peak area value of test product solution;
S0– Peak area value of comparison product solution;
C– Concentration of comparison product solution (mg/ mL);
A– Comparison product purity (%);
B– Moisture purityof the sample (%);
M– Concentration of test product solution (mg/ mL).