High Quality (DIM) Diindolylmethane 98%

Short Description:

High Quality (DIM) Diindolylmethane pharmaceutical Intermediates,Diindolylmethane is formed in the body from plant substances contained in "cruciferous" vegetables such as cabbage, Brussels sprouts, cauliflower, and broccoli.


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Coa

Products Details

Product name: Diindolylmethane

Quality standard: National standard

Specification: 99%

Test method:HPLC

CAS NO: 1968-05-4

Appearance:  off-white powder

Storage method: The product should be sealed and stored in a cool and dry place.

Shelf life: 24 months

Source of extraction: Synthetic

Package specification: 1kg / aluminum foil bag, 25kg/Drum or as required by customers.

Product introduction:

3,3'-Diindolylmethane (DIM) is a component of Indole-3-carbinol (I3C) found in members of the Brassica family. Most notably broccoli, kale, and cauliflower.


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  • 3,3′-Diindolylmethane

    1. RangeThis technical requirement specifies the technical requirements, inspection methods, inspection rules and labels of 3,3′-Diindolylmethane, a raw material for health food.This standard is applicable to 3,3′-DiindolylmethaneStandardization of reference documentThe 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.
    2. GB/T 5009.11 Determination of total arsenic and inorganic arsenic in foodGB/T 5009.12 Determination of lead in foodsGB/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)

    1. Structual formula
      3,3′-Diindolylmethane Molecular formula C17H14N2   Molecular weight 246.31   structural formula as followings:.Chart 1  Sensory index

    Item

    Requirement

    Color

    white

    Odor

    DIM special smell, bitter taste

    Property

    Dry powder

    Inpurity

    No

    4.3 Symbolic ingredient

    Conform to chart 2 requirement

    Chart 2   Symbolic ingredient

    Item

    Index

    According to dry powder DIM purity(g/100g)

    More than 30.0

    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  3,3′-Diindolylmethane

      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 diindolylmethane

     

    1. Objective to establish the standard operating procedure for the determination of diindolylmethane by HPLC.

     

    2. SCOPE: suitable for the determination of diindolylmethane.

     

    3. Reference: diindolylmethane. The above standard is provided by Sigma-aldrich.

     

    4. Reagent:

     

    4.1 methanol (chromatographic purity)

     

    4.2 methanol (analytical purity)

     

    4.3 water (ultrapure water)

     

    5. APPARATUS:

     

    5.1 High-performance Liquid Chromatography; UV DETECTOR

     

    5.2 Analytical Balance: sensitivity 0.00001G

     

    5.3 ULTRASONIC CLEANING INSTRUMENT: Power 250W, frequency 40KHz

     

    5.4 glass flow phase filter (0.45 m)5.5 needle microporous filter membrane (0.45 m)5.6 glass volumetric flask (50 ml) , measuring cylinder (100 ML) , etc. .

     

    6. Preparation of solution:

     

    6.1 preparation of Reference Solution: precision weighing to dry to constant weight of diindolylmethane reference substance, add methanol to make 1 ML of solution containing 0.02 mg, respectively, as the reference solution.

     

     6.2 preparation of the sample solution: the sample is precisely weighed and measured in a 50ML flask, the methanol is added in about 40ml, after 30 minutes of ultrasonic treatment, it is taken out at room temperature, diluted with methanol to the scale, shaken, and filtered by 0.45 m filter membrane. Kill.

     

    7.CHROMATOGRAPHIC CONDITIONS: CHROMATOGRAPHIC COLUMN: Agilent TC-C18(250 mm 4.6 mm, 5 m) detection wavelength: 280 NM

     

     flow rate: 1.0 ML/MIN INJECTION VOLUME: 10 L COLUMN TEMPERATURE: 30 °C mobile phase:

     

         A: ACETONITRILE B: water

     

    time %A %B curve

    12.00

    70

    30

     

     

     system adaptability: theoretical plate number not less than 3000

     

    8 in terms of diindolylmethane.

     

    SAMPLE DETERMINATION: under the above chromatographic conditions, after the stable base line of the instrument is stable, 10 l of the control solution and 10 l of the sample solution are precisely absorbed, and the diindolylmethane is determined for 12 Min, respectively.

     

    9. Content calculation:

     

    Where a 1: Peak area of diindolylmethane in sample solution a 0: Peak area of diindolylmethane in control solution

     

    w 1: SAMPLE WEIGHT MG W 0: Sample Weight MG v 1: Sample Volume ML v 0: sample volume ML K: purity of control, sample content results were taken as the mean values of two parallel samples.

     

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