| 检测方法 |
规格范围 |
| Food GMP Manufactured Product |
| GMP Manufactured Product |
| Meets F.C.C. Requirements |
| Meets N.F. Requirements |
| CAUTION: For Manufacturing, processing or repackaging |
| Bulk Food Chemical |
| Bulk Pharmaceutical Chemical |
| NF - Identification A |
Passes Test |
| NF - Identification B |
Passes Test |
| NF - Specific Rotation [Å]2⁵^D(calculated on dried basis)(+) |
12.0 - 13.0 Degree |
| NF - Loss on Drying |
<= 0.5 % |
| NF - Residue on Ignition |
<= 0.1 % |
| NF - Oxalate (C₂O₄) |
Passes Test |
| NF - Sulfate (SO₄) |
Passes Test |
| NF - Heavy Metals (as Pb) |
<= 10 ppm |
| NF - Assay (HOCO(CHOH)₂COOH) (dried basis) |
99.7 - 100.5 % |
| FCC - Identification A |
Passes Test |
| FCC - Identification B |
Passes Test |
| FCC - Specific Rotation [Å]2⁵^D(calculated on dried basis)(+) |
12.0 - 13.0 Degree |
| FCC - Lead (Pb) |
<= 2 mg/kg |
| FCC - Loss on Drying |
<= 0.5 % |
| FCC - Residue on Ignition |
<= 0.1 % |
| FCC - Oxalate (C₂O₄) |
Passes Test |
| FCC - Sulfate (SO₄) |
Passes Test |
| FCC - Assay (HOCO(CHOH)₂COOH) (dried basis) |
99.7 - 100.5 % |
| Manufacturer Verification |
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. |