| TEST |
SPECIFICATION |
| GMP Manufactured Product |
| Meets U.S.P. Requirements |
| Assay (C11H12N2O2) (dried basis) |
98.5 - 101.5 % |
| Identification |
Passes Test |
| Specific Rotation [a]25 D |
-32.8 - -29.4 ? |
| pH... |
5.5 - 7.0 |
| Loss on Drying at 105?C |
max. 0.3 % |
| Residue on Ignition |
max. 0.1 % |
| Chloride (Cl) |
max. 0.05 % |
| Sulfate (SO4) |
max. 0.03 % |
| Iron (Fe) |
max. 0.003 % |
| Heavy Metals (as Pb) |
max. 0.0015 % |
| Organic Impurities: |
| Total Impurities 1 |
max. 0.01 % |
| Total Impurities 2 |
max. 0.03 % |
| Tryptophan Related Compound A |
max. 10 ppm |
| Meets F.C.C. Requirements |
| Assay (C11H12N2O2) (dried basis) |
98.5 - 101.5 % |
| Identification |
Passes Test |
| Lead (Pb) |
max 5 mg/kg |
| Loss on Drying at 105?C |
max. 0.3 % |
| Residue on Ignition |
max. 0.1 % |
| Specific Rotation [a]25 D |
-32.7 - -29.7 ? |
| Meets JP Chemical Specifications |
| Assay (C11H12N2O2) (dried basis) |
98.5 - 101.0 % |
| Identification |
Passes Test |
| Specific Rotation [a]20D |
-33.0 - -30.0 ? |
| pH... |
5.4 - 6.4 |
| Clarity and Color of Solution |
Passes Test |
| Chloride (Cl) |
max. 0.021 % |
| Sulfate (SO4) |
max. 0.028 % |
| Ammonium (NH4) |
max. 0.02 % |
| Heavy Metals (as Pb) |
max. 20 ppm |
| Arsenic (As) |
max. 2 ppm |
| Related Substances |
Passes Test |
| Loss on Drying at 105?C |
max. 0.30 % |
| Residue on Ignition |
max. 0.10 % |
| Endotoxin Concentration, IU/mg |
Actual Value Reported |
| Meets Ph.Eur. Chemical Specifications |
| Identification A |
Passes Test |
| Identification B |
Passes Test |
| Identification C |
Passes Test |
| Identification D |
Passes Test |
| Appearance of Solution |
Passes Test |
| Specific Optical Rotation [a]20D |
-33.0 - -30.0 ? |
| Ninhydrin-Positive Substances |
max. 0.5 % |
| 1,1'Ethylidenebistryptophan and Other Related Subtances |
| 1,1'Ethylidenebistryptophan |
max. 10 ppm |
| Sum of the Areas less than Tryptophan? |
max. 100 ppm |
| Sum of the Areas greater than Tryptophan? |
max. 300 ppm |
| Chloride (Cl) |
max. 200 ppm |
| Sulfate (SO4) |
max. 300 ppm |
| Ammonium (NH4) |
max. 200 ppm |
| Iron (Fe) |
max. 20 ppm |
| Heavy Metals (as Pb) |
max. 10 ppm |
| Loss on Drying at 105?C |
max. 0.5 % |
| Sulfated Ash |
max. 0.1 % |
| Assay (C11H12N2O2) (dried basis) |
98.5 - 101.0 % |
| Only Class 2 Solvents (Methanol) are likely to be present. All are below Option 1 limits. |
| Bulk Food Chemical |
| Bulk Pharmaceutical Chemical |
| CAUTION: For manufacturing, processing or repacking. |
| For a Certificate of Lot Analysis, visit www.avantormaterials.com |
| Preserve in well-closed containers. |
| STORE PROTECTED FROM LIGHT |