JT Baker® 4499-08 PanExcea GR100G, Excipient Grade, 25Kg Lined Poly Drum
- 25Kg Lined Fiber Drum
- Manufacturer Part No: JT-4499-08
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Details
Product Specifications
| TEST | SPECIFICATION |
| GMP Manufactured Product | |
| CAUTION: For Manufacturing, processing or repackaging | |
| Appearance (white to off-white powder) | Passes Test |
| Identification (carbohydrate) | Passes Test |
| Identification (absence of starch) | Passes Test |
| Viscosity (1% in water) (cps) | 6000 - 12000 |
| Bulk Density | 0.05 - 0.25 g/ml |
| Loss on Drying | <= 10 % |
| Total Ash | <= 3 % |
| pH (1% in water) | 4.5 - 7.5 |
| Heavy Metals (as Pb) | <= 20 ppm |
| Class 3 Residual Solvents | <= 5000 ppm |
| Methanol | <= 3000 ppm |
| Total Aerobic Microbial Count | <= 1000 cfu/g |
| Total Yeasts and Molds | <= 100 cfu/g |
| Escherichia coli (absent) | Passes Test |
| Salmonella (absent) | Passes Test |
| Pseudomonas aeruginosa (absent | Passes Test |
| Staphylococcus aureus (absent) | Passes Test |
| Residual Solvents: Only the Class 2 solvent Methanol and Class 3 | |
| solvents are used or produced in manufacturing. Test results are | |
| reported on the Quality Certificate. | |
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Product Specifications
| TEST | SPECIFICATION |
| GMP Manufactured Product | |
| CAUTION: For Manufacturing, processing or repackaging | |
| Appearance (white to off-white powder) | Passes Test |
| Identification (carbohydrate) | Passes Test |
| Identification (absence of starch) | Passes Test |
| Viscosity (1% in water) (cps) | 6000 - 12000 |
| Bulk Density | 0.05 - 0.25 g/ml |
| Loss on Drying | <= 10 % |
| Total Ash | <= 3 % |
| pH (1% in water) | 4.5 - 7.5 |
| Heavy Metals (as Pb) | <= 20 ppm |
| Class 3 Residual Solvents | <= 5000 ppm |
| Methanol | <= 3000 ppm |
| Total Aerobic Microbial Count | <= 1000 cfu/g |
| Total Yeasts and Molds | <= 100 cfu/g |
| Escherichia coli (absent) | Passes Test |
| Salmonella (absent) | Passes Test |
| Pseudomonas aeruginosa (absent | Passes Test |
| Staphylococcus aureus (absent) | Passes Test |
| Residual Solvents: Only the Class 2 solvent Methanol and Class 3 | |
| solvents are used or produced in manufacturing. Test results are | |
| reported on the Quality Certificate. | |