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DETAILS
FUNCTION
Application
COA| ITEMS | SPECIFICATION | RESULT | METHOD |
|---|---|---|---|
| Vitamin C (Ascorbic Acid) | 99.0~100.5% | 99.4% | Titrimetry|| USP |
| Identification | A. IR conform to standard | Conform | In-house |
| B. Positive Reaction | Conform | In-house |
| Appearance | White crystalline powder | White crystalline powder | Organoleptic |
|---|---|---|---|
| Solubility | Free soluble in water, sparingly soluble in alcohol,insoluble in chloroform, in ether and in benzene | Conform | Organoleptic |
| Clarity of Solution | Clear | Clear | Organoleptic |
| Colour of Solution | NMT BY7 | <BY7 | In-house |
| Loss on Drying | NMT 0.4% | 0.04% | Karl-fischer || CP Method I |
| Residue on Ignition | NMT 0.1% | 0.03% | USP |
| Sulphate Ash | NMT 0.1% | 0.03% | USP |
| Melting Point | About 190℃ | 191℃ | USP |
| Specific Rotation[α]D20° | +20.5°~+21.5° | +20.84° | Optical Rotation|| USP |
| Bulk Density | NLT 0.8g/ml | 0.853g/ml | USP Method I |
| Tapped Density | NLT 0.9g/ml | 1.023g/ml | USP Method I |
| pH (2% water solution) | 2.4~2.8 | 2.5 | USP |
|---|---|---|---|
| pH (5% water solution) | 2.1~2.6 | 2.29 | USP |
| Organic Volatile Impurities | Methanol ≤3,000ppm | In-house | |
| Impurity E | NMT 0.2% | In-house | |
| Impurity C | NMT 0.15% | In-house | |
| Impurity D | NMT 0.15% | In-house | |
| Unspecified Impurities | NMT 0.10% | In-house | |
| Total of impurities other than C and D | NMT 0.2% | In-house | |
| Residual Solvents | Methanol: NMT 3,000ppm | GC || USP | |
| Heavy Metals(as Pb) | NMT 5ppm | USP Method II | |
| Arsenic (As) | NMT 1ppm | ICP-MS || USP | |
| Lead (Pb) | NMT 1ppm | ICP-MS || USP | |
| Cadmium (Cd) | NMT 1ppm | ICP-MS || USP | |
| Mercury (Hg) | NMT 1ppm | ICP-MS || USP | |
| Copper (Cu) | NMT 2ppm | ICP-MS || USP | |
| Iron (Fe) | NMT 2ppm | ICP-MS || USP |
| Total Plate Count | NMT 5,000cfu/g | <1,000cfu/g | USP |
|---|---|---|---|
| Total Yeast & Mold | NMT 500cfu/g | <500cfu/g | USP |
| Coliforms | NMT 10MPN/g | <10MPN/g | USP |
| E. Coli | Not Detected in(g) 10 | Not Detected | USP |
| Salmonella | Not Detected in(g) 25 | Not Detected | USP |
| Staphylococcus aureus | Not Detected in(g) 10 | Not Detected | USP |
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