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Pygeum Africanum Extract——Quality Standard
May 11, 2017

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

Using Field: This document is used to test the raw material of the Pygeum Africanum quality control of the semi-finished product 2.5% Pygeum Africanum and the quality control of the 90% Pygeum Africanum Powder

Source of The Raw Material: We use the natural bark of the Pygeum Africanum from the Southeast part of China.

Main Ingredient: Total sterols as beta-sitosterol 2.5%, 11.7% – 14.3% by GC

Main Function:

(1)It has been used in treatment of prostatic disease, especially benign prostatic hypertrophy (international stages I-II, stages II-III according to Vahlensick).

(2)Stabilization of urodynamic of the patient .

(3)Relief of symptoms, such as pollakisuria, nocturia and urinary urgency. Residual urine is reduced and urinary outflow is improved.

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:

     Pygeum extract 4:1

     Total sterols as beta-sitosterol 2.5% By GC

     Total sterols as beta-sitosterol 11.7-14.5% By GC

5. Physical and chemical reference

    English name: Prunus afrciana

    Loss on Drying:≤5.0%

    Ash content:≤3.0%

    Particle Size: 100%Through 80 mesh

    Total Heavy Metals:≤20ppm

5.2 Appearance: Red Borwn powder

5.3 Microbiological reference

   Total Plate Count  ≤1000cfu/g

   Total Yeast & Mold ≤100cfu/g

   E.Coli: Negative

   Salmonella: Negative

5.4 Assay requirement: 

     Total sterols as beta-sitosterol 2.5% By GC

     Total sterols as beta-sitosterol 11.7-14.5% By GC

5.5 Testing frequency:

 5.5.1 every 100kgs makes a batch

 5.5.2 Recheck before shipping

6. Testing requirement:

Strictly tested by standard

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.