|
PRODUCT SPECIFICATION
|
Issue No: 01
Issue Date: 01/08/2021
Doc No: TH/SP/FGX/008
Rev No: 00
|
| RED YEAST RICE EXTRACT 0.04% BY HPLC |
| Botanical Name: |
Monascus purpureus Went |
| Product Code: |
THX1787 |
| Description: |
Obtained from Monascus purpureus Went |
| Origin: |
India |
| Part Used: |
Rice |
BASIC ANALYSIS
| Analysis |
Limit/Specification |
Test Method |
| Appearance |
Powder |
In-House |
| Color* |
Brown red powder |
In-House |
| Odor/Flavor |
Characteristic |
In-House |
| Loss on Drying |
Not more than 8.0% |
USP<731> |
| Ash Content |
Not more than 8.0% |
USP<561> |
| Loose Density |
Between 0.40 - 0.70 g/ml |
USP<616> |
| Tapped Density |
Between 0.50 - 0.90 g/ml |
USP<616> |
| Particle Size |
95% pass 80 mesh |
USP<786> |
HEAVY METALS
| Analysis |
Limit/Specification |
Test Method |
| Heavy Metals |
Not more than 10.0 ppm |
USP<231> |
| Arsenic |
Not more than 2.0 ppm |
AFS |
| Lead |
Not more than 3.0 ppm |
AFS |
| Cadmium |
Not more than 1.0 ppm |
AFS |
| Mercury |
Not more than 0.1 ppm |
AFS |
MICROBIOLOGICAL ANALYSIS
| Analysis |
Limit/Specification |
Test Method |
| Total Plate Count |
Not more than 10,000 cfu/g |
USP<61> |
| Mold |
Not more than 1,000 cfu/g |
USP<61> |
| Yeast |
Not more than 1,000 cfu/g |
USP<61> |
| Coliforms |
≤0.92 MPN/g |
USP<62> |
| Escherichia coli |
Absent |
USP<62> |
| Salmonella |
Absent |
USP<62> |
CHEMICAL ANALYSIS
| Analysis |
Limit/Specification |
Test Method |
| Assay: Total Monacolin-K |
≥0.04% |
HPLC |
MYCOTOXINS
| Analysis |
Limit/Specification |
Test Method |
| Aflatoxins |
≤5 ppb |
HPLC |
| STORAGE CONDITION |
| Seal and store in a cool and dry place, avoiding direct sunlight. |
| Shelf Life: 36 months from the date of manufacture, when properly stored. |
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 Kgs Net. |
PURITY
| Aspect |
Details |
| 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.
* The product is manufactured by Pure TruHerb Pvt. Ltd.
Total Ingredients
1560 Sierra Ridge, Riverside, California, 92507, USA |
|
