JT Baker® 2249-01 Lactose, Monohydrate, Powder, NF Grade, 500g Poly Bottle (Case of 4)
- 4 x 500g Poly Bottles/Case
- Manufacturer Part No: JT-2249-01
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Details
Product Specifications
| TEST | SPECIFICATION |
| GMP Manufactured Product | |
| Meets N.F. Requirements | |
| CAUTION: For Manufacturing, processing or repackaging | |
| Bulk Pharmaceutical Chemical | |
| NF - Clarity and Color of Solution | Passes Test |
| NF - Identification A | Passes Test |
| NF - Identification B | Passes Test |
| NF - Specific Rotation [Å]²º^D (+) | 54.4 - 55.9 Degree |
| Microbial Limits - Total Aerobic Count (per g) | <= 100 |
| Microbial Limits - Total Combined Molds and Yeasts Count (per g) | <= 50 |
| Microbial Limits - Escherichia coli | Passes Test |
| NF - Acidity or Alkalinity | Passes Test |
| NF - Loss on Drying at 80°C | <= 0.5 % |
| NF - Water (H₂O) | 4.5 - 5.5 % |
| NF - Residue on Ignition | <= 0.1 % |
| ACS - Heavy Metals (as Pb) | <= 5 ppm |
| NF - Protein and Light-Absorbing Impurities | Passes Test |
| No Class 1,2,3 or other solvents are used or produced in the | |
| manufacturing or purification of the product. | |
| Metallic Residues: No metal catalysts or metal reagents, as defined by | |
| EMA Guideline EMEA/CHMP/SWP/4446/2000 , are used in the production of | |
| this material. | |
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Product Specifications
| TEST | SPECIFICATION |
| GMP Manufactured Product | |
| Meets N.F. Requirements | |
| CAUTION: For Manufacturing, processing or repackaging | |
| Bulk Pharmaceutical Chemical | |
| NF - Clarity and Color of Solution | Passes Test |
| NF - Identification A | Passes Test |
| NF - Identification B | Passes Test |
| NF - Specific Rotation [Å]²º^D (+) | 54.4 - 55.9 Degree |
| Microbial Limits - Total Aerobic Count (per g) | <= 100 |
| Microbial Limits - Total Combined Molds and Yeasts Count (per g) | <= 50 |
| Microbial Limits - Escherichia coli | Passes Test |
| NF - Acidity or Alkalinity | Passes Test |
| NF - Loss on Drying at 80°C | <= 0.5 % |
| NF - Water (H₂O) | 4.5 - 5.5 % |
| NF - Residue on Ignition | <= 0.1 % |
| ACS - Heavy Metals (as Pb) | <= 5 ppm |
| NF - Protein and Light-Absorbing Impurities | Passes Test |
| No Class 1,2,3 or other solvents are used or produced in the | |
| manufacturing or purification of the product. | |
| Metallic Residues: No metal catalysts or metal reagents, as defined by | |
| EMA Guideline EMEA/CHMP/SWP/4446/2000 , are used in the production of | |
| this material. | |