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PRODUCT SPECIFICATION
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Issue No: 01
Issue Date: 01/08/2021
Doc No: TH/SP/FGOT/008
Rev No: 00
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| L-ARGININE POWDER |
| Product Code: |
THOT40117 |
BASIC ANALYSIS
| Parameter |
Specification |
Method/Protocol |
| Description |
White or almost white crystal, crystalline powder, or colorless crystals |
Physical |
| Identification (Solubility) |
Soluble in water, sparingly soluble in alcohol, practically insoluble in ether |
USP |
| Identification (IR) |
Conforms to USP, EP STD |
Infrared Spectroscopy |
| Identification (Ninhydrine Test) |
Blue-Purple Color |
USP |
| Identification (Litmus Paper Test) |
Alkaline |
USP |
| Assay |
98.5% - 101.0% |
HPLC |
| State of Solution (Transmittance) |
Not less than 98.0% |
Spectrophotometer |
| pH (10% Solution) |
10.5 ~ 12.0 |
pH Meter |
| Loss on Drying |
Not more than 10.0% w/w |
USP <731> |
| Specific Rotation (20°C) |
+26.9° ~ +27.9° |
Polarimeter |
| Specific Rotation (25°C) |
+26.3° ~ +27.7° |
Polarimeter |
| Bulk Density |
0.40 - 0.80 g/ml |
USP <616> |
| Residue on Ignition |
Not more than 0.1% |
USP <281> |
HEAVY METALS
| Analysis |
Specification |
Test Method |
| Lead |
Not more than 0.5 ppm |
ICP-MS |
| Cadmium |
Not more than 0.5 ppm |
ICP-MS |
| Arsenic |
Not more than 1.0 ppm |
ICP-MS |
| Mercury |
Not more than 0.1 ppm |
ICP-MS |
| Iron |
Not more than 10.0 ppm |
ICP-MS |
| Chloride |
Not more than 0.02% |
ICP-MS |
| Sulfate |
Not more than 0.02% |
ICP-MS |
| Ammonium |
Not more than 0.02% |
ICP-MS |
| Total Impurities |
Not more than 0.5% |
USP |
MICROBIOLOGICAL PROFILE
| Parameter |
Specification |
Test Method |
| Total Plate Count |
Not more than 1000 cfu/g |
USP <61> |
| Yeast and Mould Count |
Not more than 100 cfu/g |
USP <61> |
| Salmonella |
Negative/25g |
USP <62> |
| Escherichia coli |
Not more than 10 cfu/g |
USP <62> |
| Coliform |
Not more than 10 cfu/g |
USP <62> |
| Bacillus cereus |
Not more than 10 cfu/g |
USP <62> |
| Staphylococcus aureus |
Negative/g |
USP <62> |
| Clostridium perfringens |
Not more than 10 cfu/g |
USP <62> |
| Clostridium botulinum |
Negative/g |
USP <62> |
| Enterobacteriaceae |
Negative/g |
USP <62> |
| STORAGE CONDITION & SHELF LIFE |
| Storage Condition: |
Ambient – Store on Pallets under cool, dry conditions, do not expose to direct sunlight or strong aromas |
| Shelf Life: |
60 months from date of manufacture |
| PACKAGING & LABELING INFORMATION |
| Type of Packaging: |
HDPE drums with LDPE inner liners |
| Labeling: |
Product Name, Weight, Batch Number, BBE, and additional information as per buyer requirement |
| Size: |
20 Kg |
PURITY INFORMATION
| Parameter |
Specification |
| 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 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.
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