Berberine

【Plant Source】: The dried bark of Phellodendron chinense Schneid. or Phellodendron amurense Rupr. from the Rutaceae family. Extraction Source: This product is extracted and refined from Phellodendron chinense and Berberis spp.

Calculated on the dried basis, it contains not less than 97% of C20H18ClNO4 for the extracted product.

【Characteristics and Properties】Yellow crystalline powder, odorless or with a slight specific odor. Extremely bitter taste. Soluble in hot water, slightly soluble in cold water or ethanol. Dried at 100°C for 5 hours,

loss on drying not more than 12% (Appendix VIII L). 

 【Residue on Ignition】Take 1.0g of the product, examine as directed (Appendix VIII L), the residue shall not exceed 0.2% (extracted product) or 0.1% (synthetic product). 

 【Heavy Metals】Take the residue obtained in the Residue on Ignition test, examine as directed (Appendix VIII H), the content of heavy metals shall not exceed 20 parts per million (synthetic product).

 【Assay】Weigh accurately about 0.3g of the product, place in a beaker, add 150ml of boiling water to dissolve, allow to cool, transfer to a 250ml volumetric flask, add accurately 50ml of potassium bromate volumetric solution (0.01667mol/L), add water to volume, shake for 5 minutes, filter through dry filter paper, accurately measure 100ml of the successive filtrate, place in a 250ml stoppered conical flask, add 2g of potassium iodide, shake to dissolve, add 10ml of acid solution (1→2), stopper tightly, mix well, allow to stand in a dark place for 10 minutes, titrate with sodium thiosulfate volumetric solution (0.1mol/L) until near the endpoint, add 2ml of starch indicator solution. Continue titration until the blue color disappears and the solution shows a bright green color, and correct the titration result with a blank test. Each 1ml of potassium bromate volumetric solution (0.01667mol/L) is equivalent to 12.39mg of C20H18ClNO4.