Macron™ 1395-88 Edetate Disodium, USP Grade, 12Kg Poly Pail
- 12Kg Poly Pail
- Manufacturer Part No: MK-1395-88
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Details
Product Specifications
TEST | SPECIFICATION |
Meets U.S.P Requirements | |
GMP Manufactured Product | |
CAUTION: For Manufacturing, processing or repackaging | |
Bulk Pharmaceutical Chemical | |
USP - Assay (C₁₀H₁₄N₂Na₂O₈) (anhydrous basis) | 99.0 - 101.0 % |
USP - Identification A | Passes Test |
USP - Identification B | Passes Test |
USP - Identification C | Passes Test |
USP - pH (1 in 20) | 4.0 - 6.0 |
USP - Loss on Drying | 8.7 - 11.4 % |
USP - Calcium (Ca) | Passes Test |
USP - Heavy Metals (as Pb) | <= 0.005 % |
USP - Limit of Nitrilotriacetic Acid | <= 0.1 % |
No Class 1,2,3 or other solvents are used or produced in the | |
manufacturing or purification of the product. | |
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 |
Meets U.S.P Requirements | |
GMP Manufactured Product | |
CAUTION: For Manufacturing, processing or repackaging | |
Bulk Pharmaceutical Chemical | |
USP - Assay (C₁₀H₁₄N₂Na₂O₈) (anhydrous basis) | 99.0 - 101.0 % |
USP - Identification A | Passes Test |
USP - Identification B | Passes Test |
USP - Identification C | Passes Test |
USP - pH (1 in 20) | 4.0 - 6.0 |
USP - Loss on Drying | 8.7 - 11.4 % |
USP - Calcium (Ca) | Passes Test |
USP - Heavy Metals (as Pb) | <= 0.005 % |
USP - Limit of Nitrilotriacetic Acid | <= 0.1 % |
No Class 1,2,3 or other solvents are used or produced in the | |
manufacturing or purification of the product. | |
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. |