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PRODUCT NAME: Hydroxypropyl methyl cellulose/ HPMC K4M
MFG DATE: 18TH OCT, 2024
EXP DATE: 18TH OCT, 2026
LOT NO.
| Executive standard | USP 43 | ||
| Items | Standard | Result | |
| Character | 1.This product is white or quasi-white fibrous or granular powder. | Conformity | |
| 2.Almost insoluble in anhydrous ethanol, ether or acetone; Swelling in cold water to form a clear or slightly turbid colloid solution. | Conformity | ||
| Identify | 1.Should be blue-green ring | Conformity | |
| 2.A flexible film should be formed | Conformity | ||
| 3. Flocculation temperature ≥ 50 ℃ | Conformity | ||
| Detection | pH | 5.0-8.0 | 6.29 |
| Viscosity （ mPa · s） | Value＜600: 80%-120% Value ≥600: 75%-140% | 4500 | |
| Loss on Drying （%） | ≤5.0 | 1.26 | |
| Residue on Ignition （%） | ≤1.5 | 0.53 | |
| Heavy Metals ppm | ≤10 | Conformity | |
| Arsenic （%） | ≤0.0002 | Conformity | |
| Contents | Methoxy （%） | 19.0-24.0 | 21.37 |
| Hydroxypropoxy （%） | 4.0-12.0 | 8.23 | |
| Microorganism | TAMC （ cfu/g） | ≤1000 | Conformity |
| TYMC（cfu/g） | ≤100 | Conformity | |
| Escherichia | Not detectable | Conformity | |
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