CERTIFICATE OF ANALYSIS

 

 

 

NAME OF PRODUCT: SILYMARIN                            BATCH NO.: 90505

MFG. DATE: JUN, 1999                                       QUANTITY: 500KGS

EXP. DATE: JUN, 2004                               REPORT DATE: JUN 5, 1999

MESH SIZE: 80 – 100 MESH

 

 

ITEMS

STANDARDS

RESULTS

CHARACTERISTICS:

YELLOW-BROWNISH POWDER WITH A SLIGHT CHARACTERISTIC ODOR,

PASS

SOLUBILITY:

SOLUBLE IN METHANOL, ETHANOL, ETHYLACETATE, INSOLUBLE IN WATER

PASS

LOSS ON DRYING:

2.5% MAX. (1G 105℃ 4HRS)

1.83%

RESIDUE ON IGNITION:

1.0% MAX.

0.31%

HEAVY METALS:

10PPM MAX.

PASS

PH:

APPROX 6.5

6.8

PARTICLE SIZE:

1MM MAX.

PASS

ASSAY:

1)  SILYMARIN

 

2) SILYBIN+ISOSILYBIN:

 

1) 70% MIN. (CALCULATED AND BASED ON ANHYDROUS AS SILYBIN)

2) 30% MIN.(CALCULATED BASED ON ANHYDROUS ACCORDING TO DAB10 HPLC CONTENT)

 

1) 76.32%

 

2) 32.19%

RESIDUE OF ACETONE:

1.0% MAX.

0.8%

MICROBIOLOGICAL:

 GERNS:

 MOLD:

 COLON BACILLUS:

 

<1000/GM

<100/GM

ABSENT

 

<10GM

<10/GM

NEGATIVE

 

CONCLUSION:

 

CONFORMS TO DAB10.

 

 

ANALYST:                              APPROVER: