| Customization: | Available |
|---|---|
| Powder: | Yes |
| Customized: | Customized |
|
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Product Name
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Pearl powder |
|
Appearance
|
White powder
|
|
Assay
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10%,20%,40% water soluble,98% fat-soluble Cromolyn (sodium)
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|
CAS No.
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/ |
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Molecular Formula
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/ |
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Molecular Weight
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/ |
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Melting point
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241-2420C (dec) |
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Grade
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Medicine Grade
|
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Test Method
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HPLC
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Storage
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Store in cool and dry place,keep away from strong light.
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Shelf life
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2 years when properly stored.
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| Item of Analysis | Specification | Results | Test Methods |
| Assay(on the anhydrous basis ) | 98%~101% | 99.20% | HPLC |
| Appearance | White powder | Conform | Visual |
| Identification | |||
| A: IR | Corresponds qualitatively to the reference | Complies | USP41-NF36 |
| B: Color Reaction | A blue color appears | Positive | USP41-NF36 |
| Water(KF) | ≤0.2% | 0.03% | USP41-NF36 |
| Residue on ignition | ≤0.1% | 0.02% | USP41-NF36 |
| Mesh size | Not less than 90% pass 80 mesh | Complies | 80 mesh screen |
| Residual Solvents | Ethanol ≤1000ppm | 18ppm | USP41-NF36 |
| Heavy metals | Inorganic arsenic ≤3μg/g | 0.06μg/g | USP41-NF36 |
| Total Hg ≤3μg/g | <0.01μg/g | USP41-NF36 | |
| Lead ≤1μg/g | 0.09μg/g | USP41-NF36 | |
| Chromatographic purity | Test 1: Coenzyme Q7,Q8,Q9,Q11 and related impurities:≤1.0% Test 2: 2Z isomer and related impurities:≤1.0% Test 1 & Test 2: ≤1.5% Test 3: The single related impurities≤0.3% |
0.37% 0.05% 0.42% 0.25% |
USP41-NF36 |
| Total Plate Count | ≤1000cfu/g | <10 cfu/g | USP41-NF36 |
| Yeast & Mold | ≤100cfu/g | <15 cfu/g | USP41-NF36 |
| E. Coli. | Negative | Negative | USP41-NF36 |
| Salmonelle | Negative | Negative | USP41-NF36 |
| S.aureus | Negative | Negative | USP41-NF36 |
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