JT Baker® 1443-08 Calcium Pantothenate, USP Grade, 1Kg Glass Bottle
- 1Kg Glass Bottle
- Manufacturer Part No: JT-1443-08
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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. |