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Quality Control of Icariin 90% HPLC
May 07, 2017

1.  Purpose: This Quality Standard is used to assure the quality of the icariin for clients.

     Using Field: This document is used to test the raw material of the icariin, quality control of the semi-finished product 85% icariin and the quality control of the 90% icariin.

     Source of The Raw Material: We use the natural dry leaf of epimedium from Shaanxi Province, China and the Southeast part of China.

     Main Ingredient: icariin

     Main Function: Enhance sexual function, Decrease the number of kidney patients in T cells, lower blood pressure and blood sugar.

2.  Standard Reference

 Chinese Pharmacopoeia               CP2005 VII C Testing of melting point

                                                       CP2005 VII E Testing of rotation                                  

                                                       CP2005 IX G Testing of loss on drying

                                                       CP2005 IX H Testing of moisture

 Chinese Pharmacopoeia               CP2005 IX E Testing of heavy metal

                                                       CP2005 IX K Testing of ash content

GB4789.2 – 1994 Microbiological examination of food hygiene  Testing of the Total Plate Count

GB4789.3 – 1994 Microbiological examination of food hygiene   Testing of the E.Coli

GB4789.4 – 1994 Microbiological examination of food hygiene   Testing of the Salmonella

GB4789.15 – 1994 Microbiological examination of food hygiene Testing of the Total Yeast & Mold

3. Terms: vacant

4. Technique reference

Icariin     >90.0%     by normalization method

Icariin     >90.0%     by external standard method (on dry basis)

5. Physical and chemical reference

    English name:  Icariin

    Structural formula: C33H40O15

    Molecular weight: 676.65 

    Solubility: Soluble in ethanol, ethyl acetate, insoluble in chloroform and ether benzene

    Melting point: 223-225 ºC

    Loss on Drying:≤5.0%

    Ash content:≤3.0%

    Particle Size: 100%Through 80 mesh

    Total Heavy Metals:≤20ppm

5.2 Appearance: from brown to light yellow powder

5.3 Microbiological reference

   Total Plate Count  ≤10000cfu/g

   Total Yeast & Mold ≤1000cfu/g

   E.Coli: Negative

   Salmonella: Negative

5.4 Assay requirement: ≥90.0%

5.5 Testing frequency:

 5.5.1 every 50kgs makes a batch

 5.5.2 Recheck before shipping

6. Testing requirement:

 6.1 Testing conditions:

Chromatographic column: Zorbax ODS-C18 375px×4.6mm 5μm

     Mobile phase: acetonitrile : water: acetic acid (20:80: 0.1V/V/V)

     Flow rate:1.0mL/min

     Column temperature: 25℃

     Measured wavelength: 220nm

     Volume of Injection: 20μL

 6.2 Solution formulation

   6.2.1 Reference solution preparation: Put accurately weighed 10mg reference icariin, which is dried to constant weight to 25ml flask. Add the mobile phase into the flask to the constant volume. Store in dark place.

   6.2.2 Sample solution preparation:Put accurately weighed 10mg sample to 25ml flask, add mobile phase into it, ultrasonic dissolve for 20mins, stay under the room temperature till constant volume. Filter through the 0.45μm filter membrane to get the sample solution.

   6.2.3 Testing: Under the condition of above chromatograph, start the testing when the baseline of the instrument becomes stable. The content of the icariin should be tested by the method of the external standard method (on dry basis)

7. Delivery method: By air, by sea

8. Supplementary: The products we produce conform with enterprise standard.

8.1 If clients have special request, please contact our technique department in advance and carry according to appoint of the contract.

8.2 If the quality of product has changed during transport, the company doesn’t charge with quality.

Our Epimedium Extract Icariin is produced by the strictly quality standard absolutely. Therefore, please trust our quality.

For any inquiry or further information, welcome contact [email protected]. Natural Field Ltd. would always provide you an all-in-one solution.

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