Specification No. H 02
HEPACEPT®
plant extract composition - bulk
Description: Mixture of concentrated and standardized plant extracts derived from:
Boswellia serrata, Polygonum cuspidatum, Curcuma longa, Scutellaria baicalensis, Silybum marianum and Piper nigrum
| Macroscopic Characters: | |
| Color: | orange-brownish |
| Odor: | spicy-incense, “curry” |
| Taste: | spicy-resinous |
| Solubility: | clear solution in 95 % acetonitril (acetone)/5 % water, poorly soluble in water |
| Composition: | |
| 1 g of the bulk consists of the following extracts: | |
| Curcuma longa (Curcumin, specification No. C 03) | |
| (HPLC, min. 90 % curcuminoids, w/w): | 335 - 355 mg |
| Boswellia serrata (Boswellic acids II, specification No. B 06) | |
| (HPLC, min. 38 % boswellic acids ABA +AKBA, w/w): | 165 - 200 mg |
| Polygonum cuspidatum (Resveratrol, specification No. R 01) | |
| (HPLC, min. 50 % resveratrol, w/w): | 175 - 200 mg |
| Scutellaria baicalensis (Baicalin, specification No. B 08) | |
| (HPLC, min. 80 % baicalin, w/w): | 175 - 200 mg |
| Silybum marianum (Silymarin, specification No. S 09) | |
| (HPLC, min. 30 % silybin, w/w, UV min. 60% silymarin): | 120 - 135 mg |
| Piper nigrum (Piperine, specification No. P 08) | |
| (HPLC, min. 90 % piperine, w/w): | 2.8 - 3.0 mg |
Content of active ingredients in 1 g of the composition: |
|
| Curcuminoids (curcumin, demethoxy- and bisdemethoxycurcumin) | min. 320 mg |
| Baicalin (baicalein-7-O-glucuronide) | min. 160 mg |
| Resveratrol and its glycosides (resveratrol complex) | min. 100 mg |
| Boswellic acids (ABA+AKBA min. 80 mg) and other triterpenes | min. 80 mg |
| Silymarin (UV, calculated as silybinin) | min. 80 mg |
| Piperine | min. 2.7 mg |
| Tests: | Limits: | Methods: |
| Appearance: | orange-brown powder | |
| Loss on drying (105°C): | max. 5.0% | Ph. Eur. 5 th Ed., <2.2.32> |
| Heavy metals: | max. 0.002% | Ph. Eur. 5 th Ed., <2.4.8> |
| Ethanol (GC): | max. 5000 ppm | NQ H02, test No. 4 |
| Acetone (GC): | max. 2500 ppm | NQ H02, test No. 5 |
| Ethyl acetate (GC): | max. 1000 ppm | NQ H02, test No. 6 |
| Microbiological tests: | ||
| Total aerobic microbial count: | <10 000 cfu/g | Ph. Eur. 5th Ed., <2.6.12> |
| Combined yeasts and molds count: | <100 cfu/g | Ph. Eur. 5th Ed., <2.6.12> |
| Escherichia coli in 1 g | absent | Ph. Eur. 5th Ed., <2.6.13> |
| Salmonella in 10 g: | absent | Ph. Eur. 5th Ed., <2.6.13> |
| Staphylococcus aureus in 1 g: | absent | Ph. Eur. 5th Ed., <2.6.13> |
| Storage conditions: Keep in dark, dry place, up to 25°C. | ||
| Shelf life: 2 years | ||
*NQ = Norm of Quality
This specification supersedes the specification No. H 02, version 4 issued on July 13, 2005.