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herbs, fruits, dried herbs, roots, rhizome, leaves, seeds, bark
STANDARDIZED EXTRACTS
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SILYMARIN EXTRACT
EB0001-103-02 |
| INFORMATION
OF SILYMARIN POWDER EXTRACT |
| BOTANICAL NAME: |
Silybum marianum |
| PART OF PLANT USED: |
Seed |
| COUNTRY OF ORIGIN: |
Bulgaria |
| CULTIVATED HERB: |
Yes |
| NATURAL HERB: |
Yes |
| STERILIZATION METHOD USED IF ANY: |
No need to sterilize |
| MICROBIOLOGY – MOULD, YEAST: |
Refer to Eur Ph III |
| HEAVY METALS: |
Not more than 200 ppm |
| NUTRITION INFORMATION: |
Not less than 70% Silymarin |
| MATERIAL SAFETY DATA SHEETS: |
Available upon request |
| METHOD OF ANALYSIS: |
|
| PHOTO SPECTRAPHOTOMATRY: |
UV-VIS |
| HPLC: |
HPLC |
| KNOWN FORMULATION
INCOMPATIBILITIES: |
N/A |
| MUST BE HOMOGENEOUS BLEND: |
Yes |
|
SEASONAL – HARVESTING:
|
During July and August, but stock up raw material to
manufacture all year round
|
| CERTIFICATE OF ANALYSIS: |
Yes |
| % OF ACTIVE: |
Not less than 70% Silymarin |
TECHNICAL DATA SHEET |
| SILYMARIN |
|
| NAME OF THE PLANT: |
Silybum marianum |
| PART OF THE PLANT USED: |
Seeds |
| APPEARANCE: |
Powder extract |
|
CHEMICAL DEFINITION:
|
Mixture of flavonolignans, in which Silibinin
predominates. Other isomers are named Silidianin,
Silicristin and Taxifolin.
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SYNONYMS:
|
Silybinum marianum purified extract
|
 |
| STRUCTURAL FORMULA: (SILIBININ) |
C25H22O10.H2O |
| MOLECULAR WEIGHT: |
500.47 |
| STORAGE: |
Keep well closed |
TECHNICAL DESCRIPTION: |
| APPEARANCE: |
Yellow or yellow-brownish powder,
with characteristic odour |
| SOLUBILITY: |
Soluble in Methanol, slightly
soluble in Ethylacetate, insoluble in Chloroform, Water and
Hexane |
| WATER CONTENT (K.Fischer): |
Not more than 6.0% |
| IDENTITY: |
Colour test HPLC |
| SULPHATED ASH: |
Not more than 0.5 % |
| HEAVY METALS: |
Not more than 0.02 % |
| ASSAY: |
Spectrophotometric content of
silibinin: Not less than 65 % HPLC: Not less than 31 % (HPLC) |
| MICROBIOLOGY: |
|
| BACTERIA: |
Not more than 1000 CFU/g |
| YEAST AND MOULDS: |
Not more than 100 CFU/g |
| STAPHYLOCOCCUS AUREUS: |
Absent |
| SALMONELLAE: |
Absent |
| PSEUDOMONAS AERUGINOSAE: |
Absent |
| ESCHERICHIA COLI: |
Absent |
| REPORTED USES: |
Silymarin is a
pharmaceutical of plant origin. It strengthens cell
membranes and improves metabolism, stimulates protein
synthesis in hepatic cells. Improves the disturbed hepatic
function and the general condition of the patient, enhances
the appetite. It protects the hepatic cells from toxic
effect and from accumulation of lipids in them. Sylimarin is
non-toxic and is assimilated very well by the body. |
| THERAPEUTICAL CATEGORY: |
Hepatoprotectant |
SILYMARIN EXTRACT
EB0001-103-02
|
| CERTIFICATE OF ANALYSIS CONTENT |
| DESCRIPTION - brownish-yellow powder |
CORR.
|
| ODOUR - slight, specific |
CORR.
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| IDENTIFICATION |
CORR.
|
| CLARITY AND COLOUR OF SOLUTION |
CORR.
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- SOLUBILITY- in methanol, slightly soluble in ethyl
acetate, soluble in chloroform, hexane and water
|
CORR.
|
| WATER-(K.FISHER) |
max 6.00%
|
| SULPHATED ASH |
max 0.50%
|
| HEAVY METALS |
max 0.02%
|
SPECTROPHOTOMETRIC CONTENT
OF SILYMARIN (IN DRIED SAMPLE) |
min 65.00%
|
HPLC CONTENT OF SILYMARIN, %
TAXIFOLIN
SILYDIANIN
SILYCRISTIN
SILYBIN
ISO-SILYBIN
TOTAL (IN DRIED SAMPLE) |
|
| MICROBIOLOGY PURITY in g product |
CORR.
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