JT Baker® 4489-08 PanExcea MHC300G, Excipient Grade, 25Kg Lined Fiber Drum
- 25Kg Lined Fiber Drum
- Manufacturer Part No: JT-4489-08
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Details
Product Specifications
| TEST | SPECIFICATION |
| GMP Manufactured Product | |
| CAUTION: For Manufacturing, processing or repackaging | |
| Appearance | Passes Test |
| Identification A (MCC by FTIR) | Passes Test |
| Identification B (MCC by chemical) | Passes Test |
| Identification C (HPMC by FTIR) | Passes Test |
| Identification D (Crospovidone by FTIR) | Passes Test |
| Bulk Density | 0.22 - 0.35 |
| Tapped Density | 0.28 - 0.45 |
| Total Nitrogen (as %) | 0.95 - 1.32 % |
| Loss on Drying | <= 6.0 % |
| Heavy Metals | <= 10 ppm |
| MCC % (w/w) | 86.5 - 91.5 % |
| HPMC % (w/w) | 1.0 - 3.0 % |
| Crospovidone % (w/w) | 7.5 - 10.5 % |
| Particle Size Distribution: % Cumulative Retained on 60 Mesh | <= 10 % |
| Particle Size Distribution: % Cumulative Retained on 200 Mesh | 60 - 95 % |
| No Class 1,2,3 or other solvents are used or produced in the manufacturing or purification of the product. | |
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Product Specifications
| TEST | SPECIFICATION |
| GMP Manufactured Product | |
| CAUTION: For Manufacturing, processing or repackaging | |
| Appearance | Passes Test |
| Identification A (MCC by FTIR) | Passes Test |
| Identification B (MCC by chemical) | Passes Test |
| Identification C (HPMC by FTIR) | Passes Test |
| Identification D (Crospovidone by FTIR) | Passes Test |
| Bulk Density | 0.22 - 0.35 |
| Tapped Density | 0.28 - 0.45 |
| Total Nitrogen (as %) | 0.95 - 1.32 % |
| Loss on Drying | <= 6.0 % |
| Heavy Metals | <= 10 ppm |
| MCC % (w/w) | 86.5 - 91.5 % |
| HPMC % (w/w) | 1.0 - 3.0 % |
| Crospovidone % (w/w) | 7.5 - 10.5 % |
| Particle Size Distribution: % Cumulative Retained on 60 Mesh | <= 10 % |
| Particle Size Distribution: % Cumulative Retained on 200 Mesh | 60 - 95 % |
| No Class 1,2,3 or other solvents are used or produced in the manufacturing or purification of the product. | |