Luteolin HPLC 98% factory

Short Description:

luteolin is widely a naturally occurring molecule known as bioflavonoid, often found in foods including parsley, artichoke leaves, celery, peppers, olive oil, Luteolin is slightly soluble in water, weakly acidic, solublein alkaline solution, stable under normal conditions.it's made from rutin.


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Quality Standand

Coa

Product Name:  Luteolin

Latin name:Arachis hypogaea L

Quality standard:CP2015&US CHROMADEX

Specification: 98%

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.


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  • Luteolin

    1. Range

    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).

    3.Structual formula

    Luteolin      Molecular formula C15H10O6  Molecular weight 286.24

    4.Technical requirements

    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

    Item

    Requirement

    Color

    Light yellow

    Ordor

    Luteolin special smell

                               Property

    Dry powder

                                Inpurity

    No

    4.3 Symbolic ingredient

    Conform to chart 2 requirement

    Chart 2   Symbolic ingredient

    Item

    Index

    According to dry powder luteolin purityg/100g

    More than 98.0

    4.4 Physicochemical requirement

    Conform to chart 3 requirement

    Chart 3 Physicochemical requirement

    Item

    Index

    Partical size[80 mesh pass %]     

    90.0

    Moisture%)       

    1.0

    Ash content%)   

    1.0

    As/mg/kg)        

    1.0

    Pb/mg/kg)        

    1.0

    Cd/mg/kg)        

    0.5

    Hg/mg/kg)        

    0.5

    Hexachloro-cyclohexane soprocide mg/kg)              

    0.1

    DDT mg/kg)              

    0.1

    Huintozene mg/kg)       

    0.1

    4.5 Microbiological indicator

    Conform to chart 4 requirement

    Chart 4 Microbiological indicators

    Item

    Index

    Total Plate Count/cfu/g)   

    1000

    Yeast & Mold/cfu/g)       

    100

    Salmonella

    No

    E.Coli

    No

    Staphylococcus

    No

    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

    5.2.2 Mesh

    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).

    5.2.3 Moisture

    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)

    5.2.5 Arsenic

    The total arsenic and inorganic arsenic in food were determined according to GB/T 5009.11 method.

    5.2.6 Lead

    According to GB/T 5009.12 for the determination of lead in food.

    5.2.7 Cadmium

    Cadmium in food was determined according to GB/T 5009.15.

    5.2.8 Hg

    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

    5.4.3 E.Coli

    In accordance with the “national food hygiene standard” GB4789.3

    5.4.4 Salmonella

    In accordance with the “national food hygiene standard” GB4789.4

    5.4.5 Staphylococcus

    In accordance with the “national food hygiene standard” GB4789.10

    6 Test rule

    6.1 Test

    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 Transportation

    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 Storage

    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) :

    Luteolin%)=………..(B.1)

    in

    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).

    l98

    rutin_副本

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