L(-)-Tryptophan 98.5-101.5% (dried basis) USP, Multi-Compendial, J.T.Baker®
Supplier: AVANTOR PERFORMANCE MATERIALS US
Synonyms:
L-Tryptophan, Tryptophan, L-α-Amino-3-indolepropionic acid, (S)-2-Amino-3-(3-indolyl)propionic acid, H-Trp-OH
Management of Change (MOC) category = R
2092-06
BAKR2092-07
JT2092-6EA
3019.42
USD
JT2092-6
JT2092-7
L(-)-Tryptophan 98.5-101.5% (dried basis) USP, Multi-Compendial, J.T.Baker®
L(-)-Tryptophan
White crystals.
- Food GMP manufactured product
|
Formula:
C₁₁H₁₂N₂O₂ MW: 204.23 g/mol Melting Pt: 290 °C Density: 1.34 g/cm³ (20 °C) Storage Temperature: Ambient |
MDL Number:
MFCD00064340 CAS Number: 73-22-3 EINECS: 200-795-6 Merck Index: 12,09929 |
Specification Test Results
| GMP Manufactured Product | |
| Meets J.P. Chemical Specifications | |
| Meets E.P. Chemical Specifications | |
| Meets U.S.P Requirements | |
| Preserve in well-closed containers. | |
| Store in well-closed,light-resistant containers | |
| CAUTION: For Manufacturing, processing or repackaging | |
| Bulk Pharmaceutical Chemical | |
| USP - Assay (C₁₁H₁₂N₂O₂) (dried basis) | 98.5 - 101.5 % |
| USP - Identification | Passes Test |
| USP - Specific Rotation [Å]²⁵ ^D | -32.8 - -29.4 Degree |
| USP - pH | 5.5 - 7.0 |
| USP - Loss on Drying at 105°C | ≤0.3 % |
| USP - Residue on Ignition | ≤0.1 % |
| USP - Chloride (Cl) | ≤0.05 % |
| USP - Sulfate (SO₄) | ≤0.03 % |
| USP - Iron (Fe) | ≤0.003 % |
| USP - Organic Impurities - Total Impurities 1 | ≤0.01 % |
| USP - Organic Impurities - Total Impurities 2 | ≤0.03 % |
| USP - Organic Impurities - Tryptophan Related Compound A | ≤10 ppm |
| JP - Assay (C₁₁H₁₂N₂O₂) (dried basis) | 98.5 - 101.0 % |
| JP - Identification | Passes Test |
| JP - Specific Rotation [Å]²º^D | -33.0 - -30.0 Degree |
| JP - pH | 5.4 - 6.4 |
| JP - Clarity and Color of Solution | Passes Test |
| JP - Chloride (Cl) | ≤0.021 % |
| JP - Sulfate (SO₄) | ≤0.028 % |
| JP - Ammonium (NH₄) | ≤0.02 % |
| JP - Heavy Metals (as Pb) | ≤20 ppm |
| JP - Arsenic (As) | ≤2 ppm |
| JP - Related Substances | Passes Test |
| JP - Loss on Drying at 105°C | ≤0.30 % |
| JP - Residue on Ignition | ≤0.10 % |
| Endotoxin Concentration, IU/mg, For Information Only | |
| EP - Identification A | Passes Test |
| EP - Identification B | Passes Test |
| EP - Appearance of Solution | Passes Test |
| EP - Specific Optical Rotation [Å]²º^D | -33.0 - -30.0 Degree |
| EP/BP-Ninhydrin-Positive Substances-Each | ≤0.2 % |
| EP/BP-Ninhydrin-Positive Substances-Total Impurities | ≤0.5 % |
| EP - 1,1'Ethylidenebistryptophan | ≤10 ppm |
| EP - Sum of the Areas less than Tryptophan® | ≤100 ppm |
| EP - Sum of the Areas greater than Tryptophan® | ≤300 ppm |
| EP - Chloride (Cl) | ≤200 ppm |
| EP - Sulfate (SO₄) | ≤300 ppm |
| EP/BP - Ammonium (NH₄) | ≤0.02 % |
| EP - Iron (Fe) | ≤20 ppm |
| EP - Loss on Drying at 105°C | ≤0.5 % |
| EP - Sulfated Ash | ≤0.1 % |
| EP - Assay (C₁₁H₁₂N₂O₂) (dried basis) | 98.5 - 101.0 % |
| Only Class 2 Solvents (Methanol) are likely to be present. All are | |
| below Option 1 limits. | |
| Elemental Impurities (USP (232), EP 5.20) - Information on elemental | |
| impurities for this product is available on the associated Product | |
| Regulatory Data Sheet and elemental impurity profile report. |
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