| 检测方法 |
规格范围 |
| GMP Manufactured Product |
| Meets U.S.P Requirements |
| CAUTION: For Manufacturing, processing or repackaging |
| Bulk Pharmaceutical Chemical |
| 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 - Nitrilotriacetic Acid |
<= 0.1 % |
| USP - Assay (C₁₀H₁₄N₂Na₂O₈) (dried basis) |
99.0 - 101.0 % |
| 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. |