JT Baker® 1443-03 Calcium Pantothenate, USP Grade, 25g Glass Bottle (Case of 4)
- 25g Glass Bottle, Case of 4
- Manufacturer Part No: JT-1443-03
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Details
Product Specifications
| TEST | SPECIFICATION |
| GMP Manufactured Product | |
| Meets U.S.P Requirements | |
| CAUTION: For Manufacturing, processing or repackaging | |
| Bulk Pharmaceutical Chemical | |
| Identification A | Passes Test |
| Identification B | Passes Test |
| Identification C (Specific Rotation [Å]²⁵ ^D (+)) | 25.0 - 27.5 Degree |
| Alkalinity | Passes Test |
| Loss on Drying | <= 5.0 % |
| Heavy Metals (as Pb) | <= 0.002 % |
| Assay (C₁₈H₃₂CaN₂O₁₀)(dried basis) | 98.0 - 102.0 % |
| Content of Calcium (Ca)(dried basis) | 8.2 - 8.6 % |
| Solution Test | Passes Test |
| Only Class 2 solvents (Methanol, Dichloromethane) are likely to be | |
| present. All are below Option 1 limits. | |
| Meets Reagent Specifications for testing USP/NF monographs | |
| 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 U.S.P Requirements | |
| CAUTION: For Manufacturing, processing or repackaging | |
| Bulk Pharmaceutical Chemical | |
| Identification A | Passes Test |
| Identification B | Passes Test |
| Identification C (Specific Rotation [Å]²⁵ ^D (+)) | 25.0 - 27.5 Degree |
| Alkalinity | Passes Test |
| Loss on Drying | <= 5.0 % |
| Heavy Metals (as Pb) | <= 0.002 % |
| Assay (C₁₈H₃₂CaN₂O₁₀)(dried basis) | 98.0 - 102.0 % |
| Content of Calcium (Ca)(dried basis) | 8.2 - 8.6 % |
| Solution Test | Passes Test |
| Only Class 2 solvents (Methanol, Dichloromethane) are likely to be | |
| present. All are below Option 1 limits. | |
| Meets Reagent Specifications for testing USP/NF monographs | |
| 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. | |