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. |