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Physicochemical Specifications:
INSPECTION STANDARD | |||
No. | ITEM | STANDARD | METHOD |
1 | Appearance | White or off-white powder | Visual |
2 | Clarity and color | ≤0.350 | USP<857> |
3 | Identification | Meets the Requirement | USP<197> |
4 | Electrophoretic purity | ≤2.0% | USP 43 |
5 | Content by CPC | ≥90.00%,on the dried base | USP<541> |
6 | Specific Rotation | -20.00°~-30.00° | USP<781S> |
7 | pH Value | 5.5-7.5 | USP<791> |
8 | Loss on Drying | ≤10.00% | USP<731> |
9 | Residue on Ignition | 20%～30% | USP<281> |
10 | Chloride | ≤0.50% | USP<221> |
11 | Sulfate | ≤0.24% | USP<221> |
12 | Limit of Protein | ≤6.0% | USP<857> |
13 | Heavy Metals | ≤20ppm | USP<231>MethodⅡ |
14 | Residual Solvents(Ethanol) | ≤5,000ppm | Method in house |
15 | Total bacterial count | ≤1,000cfu/g | USP<2021> |
16 | Yeast and Mold | ≤100 cfu/g | USP<2021> |
17 | Sieve Analysis | 100%through 80 mesh | Method in house |
Physicochemical Specifications:
INSPECTION STANDARD | |||
No. | ITEM | STANDARD | METHOD |
1 | Appearance | White or off-white powder | Visual |
2 | Clarity and color | ≤0.350 | USP<857> |
3 | Identification | Meets the Requirement | USP<197> |
4 | Electrophoretic purity | ≤2.0% | USP 43 |
5 | Content by CPC | ≥90.00%,on the dried base | USP<541> |
6 | Specific Rotation | -20.00°~-30.00° | USP<781S> |
7 | pH Value | 5.5-7.5 | USP<791> |
8 | Loss on Drying | ≤10.00% | USP<731> |
9 | Residue on Ignition | 20%～30% | USP<281> |
10 | Chloride | ≤0.50% | USP<221> |
11 | Sulfate | ≤0.24% | USP<221> |
12 | Limit of Protein | ≤6.0% | USP<857> |
13 | Heavy Metals | ≤20ppm | USP<231>MethodⅡ |
14 | Residual Solvents(Ethanol) | ≤5,000ppm | Method in house |
15 | Total bacterial count | ≤1,000cfu/g | USP<2021> |
16 | Yeast and Mold | ≤100 cfu/g | USP<2021> |
17 | Sieve Analysis | 100%through 80 mesh | Method in house |
