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HPMC E6 USP,EP,JP
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Cellulose series
HPMC E6 USP,EP,JP
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CERTIFICATE OF ANALYSIS
| Sample Name | HYDROXY PROPYL METHYL CELLULOSE（HPMC） | |||
| Grade | 2910 | Type | E6 | |
| Quantity | 5000kg | Manufacturing Date | May.08,2024 | |
| Batch No. | 240508 | Expiry date | May.08,2026 | |
| Test project | All the analysis | |||
| Items | Standard | Result | ||
| Description | White to slightly off-white fibrous or granular powder. Swells in water and produces a clear to opalescent, viscous colloidal mixture. | Conformity | ||
| Appearance of Solution | A:The powdered material aggregates on the surface. | Conformity | ||
| B:The resulting liquid is a clear or slightly turbid solution with thickness dependent on the viscosity grade. | ||||
| C:A red color develops at first that changes to purple within 100 min. | ||||
| D:A coherent clear film forms on the glass slide. | ||||
| E:The flocculation temperature is higher than 50℃ . | ||||
| Assay(by GC) | Hydroxypropoxy:7%-12.0% | 8.0 | ||
| Methoxy: 28.0%-30.0% | 29.0 | |||
| Solubility | Conforms | |||
| PH | 5.0-8.0 | 5.8 | ||
| Viscosity, mPa·S | Value＜600: 80%-120% Value ≥600: 75%-140% | 5.8 | ||
| Water-insoluble Substances, % | ≤0.5 | 0.3 | ||
| Loss on Drying, % | ≤5.0 | 2.0 | ||
| Ash content, % | ≤1.5 | 0.6 | ||
| Heavy Metal, ppm | ≤10 | Conform | ||
| Arsenic % | ≤0.0002 | Conform | ||
| Bioburden | ||||
| TAMC cfu/g | ≤600 | Conform | ||
| TYMC cfu/g | ≤60 | Conform | ||
| Escherichia Coli | Negative | Not Detect | ||
| Material complies with USP/EP/JP | ||||
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