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PRODUCT SPECIFICATION
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Issue No: 01
Issue Date: 01/08/2021
Doc No: TH/SP/FGX/008
Rev No: 00
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| BERBERINE HCL 97% BY TITRATION |
| Product Code: |
THX1927 |
| Description: |
Yellow crystalline powder |
| Origin: |
India |
BASIC ANALYSIS
| Analysis |
Limit/Specification |
Test Method |
| Appearance |
Crystalline Powder |
Visual |
| Color* |
Yellow |
In-House |
| Moisture % |
Not more than 12% |
Ch.P<0832> |
| Total impurities % |
Not more than 4% |
Enterprise method |
| Acidity |
Meet the requirements |
Enterprise method |
| Residue on ignition % |
Not more than 0.1% |
Ch.P<0841> |
HEAVY METALS
| Analysis |
Limit/Specification |
Test Method |
| Heavy metal |
NMT 10.0 ppm |
USP<231> |
| Lead |
NMT 2 ppm |
USP<852> |
| Arsenic |
NMT 1 ppm |
USP<852> |
| Cadmium |
NMT 2 ppm |
USP<852> |
| Mercury |
NMT 0.1 ppm |
USP<852> |
CHEMICAL ANALYSIS
| Analysis |
Limit/Specification |
Test Method |
| Berberine Hydrochloride |
95%-102% |
Titration |
MICROBIOLOGICAL ANALYSIS
| Analysis |
Limit/Specification |
Test Method |
| Total plate count |
NMT 1000 cfu/g |
USP<61> |
| Yeast & Mold |
NMT 100 cfu/g |
USP<61> |
| Salmonella |
Absent |
USP<62> |
| E. Coli |
Absent |
USP<62> |
| STORAGE CONDITION |
| Store in a well-closed place with constant low temperature and no direct sunlight. |
| Shelf Life: 36 months from date of manufacture. |
PACKAGING & LABELLING INFORMATION
| PACKAGING |
SPECS |
| Type of Packaging |
Pack in paper-drums and two food-grade poly bags inside |
| Labeling |
Product Name, Weight, Batch Number, BBE and additional information as per buyer requirement |
| Size |
25 Kg Net. |
| PURITY |
| Adulteration |
Free from adulteration |
| Additives |
Free from additives |
| GMO |
Free from GMO |
| Foreign Matter |
Absence of hazardous material such as excreta, glass, metal, stones, hard plastic, wood splinters, and other hard materials |
| Infestation |
Free from live or dead insects, insect fragments, and rodent contamination visible to the naked eye |
| Irradiation |
Free from irradiation |
ALLERGEN INFORMATION
| ALLERGEN |
CONTAINS |
| Peanut & peanut related Products |
☐ YES ☒NO |
| Tree Nuts & Tree nut derived products |
☐ YES ☒NO |
| Fish & fish products |
☐ YES ☒NO |
| Egg & Egg products |
☐ YES ☒NO |
| Wheat, rye, Barley, Corn, Related Grains & their products |
☐ YES ☒NO |
| Crustacean & their products |
☐ YES ☒NO |
| Milk and Milk Products |
☐ YES ☒NO |
| Soy and soy related items |
☐ YES ☒NO |
| Legumes |
☐ YES ☒NO |
| Molluscs |
☐ YES ☒NO |
| Sesame Seeds |
☐ YES ☒NO |
| Cotton seeds |
☐ YES ☒NO |
* The color may slightly vary naturally depending on ripeness, seasons, climate, and geographical area of raw material.
Total Ingredients: 1560 Sierra Ridge, Riverside, California, 92507, USA
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