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.
For any inquiry or further information, welcome contact info@natural-field.com. Natural Field Ltd. would always provide you an all-in-one solution.