L(+)-Lyzin monohydrochlorid 98.5-101.5% (dried basis), GenAR® USP, Multi-Compendial, Macron Fine Chemicals™
Dodavatel: Avantor Performance Materials
4933-09EA
276440
CZK
4933-09
MACR4933-06
L(+)-Lyzin monohydrochlorid 98.5-101.5% (dried basis), GenAR® USP, Multi-Compendial, Macron Fine Chemicals™
L(+)-Lyzin monohydrochlorid
Vzorec:
H₂N(CH₂)₄CH(NH₂)CO₂H·HCl |
MDL Number:
MFCD00064564 CAS číslo: 657-27-2 |
Výsledky specifikačního testu
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) |
|
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 |
|
JP - Residue on Ignition |
|
Endotoxin Concentration, IU/mg, For Information Only | 19.0 - 21.5 Degree |
No Class 1,2,3 or other solvents are used or produced in the | 5.0 - 6.0 |
manufacturing or purification of the product. | Passes Test |
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. |
|
Endotoxin Concentration, IU/mg | For Information Only |
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