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PRODUCT SPECIFICATION
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Issue No: 01
Issue Date: 01/08/2021
Doc No: TH/SP/FGOT/010
Rev No: 00
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| Ascorbic Acid Powder |
| Product Code: |
THOT40066 |
PHYSICAL ANALYSIS
| Parameter |
Specification |
Method/Protocol |
| Description |
White or almost white crystalline powder or colorless crystals with characteristic odor and taste. |
Physical |
| Loss on drying |
Not more than 0.1% w/w |
USP <731> |
| Residue on ignition |
Not more than 0.1% |
USP <281> |
| Identification A |
Positive reaction |
USP |
| Identification B |
Comply to IR |
IR |
| Melting Point |
About 190°C |
USP |
| Specific Rotation |
+20.5° To +21.5° |
USP |
| Solubility |
Freely soluble in water, slightly soluble in ethanol, insoluble in chloroform. |
USP <1236> |
| pH (5%, W/V) |
2.1-2.6 |
USP <791> |
| pH (2%, W/V) |
2.4-2.8 |
USP <791> |
| Clarity of solution |
Clear |
USP |
| Color of solution |
NMT BY7 |
USP |
| Total of impurities |
NMT 0.2% |
USP |
HEAVY METALS
| Parameter |
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 |
| Copper |
Not more than 5.0 ppm |
USP |
| Iron |
Not more than 2.0 ppm |
USP |
ASSAY
| Parameter |
Specification |
Test Method |
| Assay |
99.0% - 100.5% |
USP |
MICROBIOLOGICAL PROFILE
| Parameter |
Specification |
Test Method |
| Total plate count |
Not more than 1,000cfu/g |
USP <61> |
| Yeast and mould count |
Not more than 100cfu/g |
USP <61> |
| Coliform |
Absent |
USP <62> |
| Salmonella |
Absent |
USP <62> |
| Escherichia coli |
Absent |
USP <62> |
| STORAGE CONDITION & SHELF LIFE |
| Storage Condition: |
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
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| Size: |
25 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
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| Infestation |
Free from live or dead insects, insect fragments, and rodent
contamination visible to naked eye
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| 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 |
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Wheat, rye, Barley, Corn, Related grains & their products
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☐ 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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