L(+)-Lysine monohydrochloride 98.5-101.5% (dried basis), GenAR® USP, Multi-Compendial, Macron Fine Chemicals™
Supplier: AVANTOR PERFORMANCE MATERIALS US
MACR4933-09
4933-06
MK4933-09EA
13407.2
USD
MK4933-09
MK4933-06
L(+)-Lysine monohydrochloride 98.5-101.5% (dried basis), GenAR® USP, Multi-Compendial, Macron Fine Chemicals™
L(+)-Lysine monohydrochloride
|
Formula:
H₂N(CH₂)₄CH(NH₂)CO₂H·HCl |
MDL Number:
MFCD00064564 CAS Number: 657-27-2 |
Specification Test Results
| Meets J.P. Chemical Specifications | |
| Meets E.P. Chemical Specifications | |
| Meets U.S.P Requirements | |
| GMP Manufactured Product | |
| Meets B.P. Chemical Specifications | |
| CAUTION: For Manufacturing, processing or repackaging | |
| Bulk Pharmaceutical Chemical | |
| USP - Assay (C₆H₁₄N₂O₂·HCl) (dried basis) | 98.5 - 101.5 % |
| USP - Identification | Passes Test |
| USP - Specific Rotation [Å]²⁵ ^D (+) | 20.4 - 21.4 Degree |
| USP - Loss on Drying at 105°C | ≤0.4 % |
| USP - Residue on Ignition | ≤0.1 % |
| USP - Sulfate (SO₄) | ≤0.03 % |
| USP - Iron (Fe) | ≤0.003 % |
| USP - Related Compounds - Individual Impurities | ≤0.5 % |
| USP - Related Compounds - Total Impurities | ≤2.0 % |
| USP - Chloride (Cl) | 19.0 - 19.6 % |
| EP/BP - Assay (C₆H₁₄N₂O₂·HCl) (dried basis) | 98.5 - 101.0 % |
| EP/BP - Identification A | Passes Test |
| EP/BP - Identification B | Passes Test |
| EP/BP - Identification E | Passes Test |
| EP/BP - Appearance of Solution | Passes Test |
| EP/BP - Specific Rotation [Å]²º^D (+) | 21.0 - 22.5 Degree |
| EP/BP-Ninhydrin-Positive Substances-Each | ≤0.2 % |
| EP/BP-Ninhydrin-Positive Substances-Total Impurities | ≤1.0 % |
| EP/BP - Sulfate (SO₄) | ≤300 ppm |
| EP/BP - Ammonium (NH₄) | ≤0.02 % |
| EP/BP - Iron (Fe) | ≤30 ppm |
| EP/BP - Loss on Drying at 105°C | ≤0.5 % |
| EP/BP - Ash (sulfated) | ≤0.1 % |
| JP - Assay (C₆H₁₄N₂O₂·HCl) (dried basis) | 98.5 - 101.0 % |
| JP - Identification A | Passes Test |
| JP - Identification B | Passes Test |
| JP - Optical Rotation (+) | 19.0 - 21.5 Degree |
| JP - pH (1 in 10) | 5.0 - 6.0 |
| JP - Clarity and Color of Solution | Passes Test |
| JP - Sulfate (SO₄) | ≤0.028 % |
| JP - Ammonium (NH₄) | ≤0.02 % |
| JP - Heavy Metals (as Pb) | ≤10 ppm |
| JP - Arsenic (As) | ≤2 ppm |
| JP - Related Substances | Passes Test |
| JP - Loss on Drying at 105°C | ≤1.0 % |
| JP - Residue on Ignition | ≤0.10 % |
| Endotoxin Concentration, IU/mg, For Information Only | |
| No Class 1,2,3 or other solvents are used or produced in the | |
| manufacturing or purification of the product. | |
| 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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