L(+)-Histidine 98.5-101.5% (dried basis) USP, FCC, Multi-Compendial, Macron Fine Chemicals™
Supplier: AVANTOR PERFORMANCE MATERIALS US
Management of Change (MOC) category = R
MACR4935-06
MACR4935-09
4935-07
MK4935-06EA
2336.1
USD
MK4935-06
MK4935-09
MK493507
L(+)-Histidine 98.5-101.5% (dried basis) USP, FCC, Multi-Compendial, Macron Fine Chemicals™
L(+)-Histidine
Formula:
C₆H₉N₃O₂ Density: 1.44 g/cm³ |
MDL Number:
MFCD00064315 CAS Number: 71-00-1 |
Specification Test Results
Meets B.P. Chemical Specifications | |
Meets J.P. Chemical Specifications | |
GMP Manufactured Product | |
Meets U.S.P Requirements | |
Meets E.P. Chemical Specifications | |
CAUTION: For Manufacturing, processing or repackaging | |
Bulk Pharmaceutical Chemical | |
USP - Assay (C₆H₉N₃O₂) (dried basis) | 98.5 - 101.5 % |
USP - Identification | Passes Test |
USP - Specific Rotation [Å]²⁵ ^D (+) | 12.6 - 14.0 Degree |
USP - pH | 7.0 - 8.5 |
USP - Loss on Drying at 105°C | ≤ 0.2 % |
USP - Residue on Ignition | ≤ 0.4 % |
USP - Chloride (Cl) | ≤ 0.05 % |
USP - Sulfate (SO₄) | ≤ 0.03 % |
USP - Iron (Fe) | ≤ 0.003 % |
USP - Related Compounds - Individual Impurities | ≤ 0.5 % |
USP - Related Compounds - Total Impurities | ≤ 2.0 % |
EP/BP - Assay (C₆H₉N₃O₂) (dried basis) | 98.5 - 101.0 % |
EP/BP - Identification A | Passes Test |
EP/BP - Identification B | Passes Test |
EP/BP - Appearance of Solution | Passes Test |
EP/BP - Specific Rotation [Å]²º^D (+) | 11.4 - 12.4 Degree |
EP/BP-Ninhydrin-Positive Substances-Each | ≤ 0.2 % |
EP/BP-Ninhydrin-Positive Substances-Total Impurities | ≤ 0.5 % |
EP/BP - Chloride (Cl) | ≤ 200 ppm |
EP/BP - Sulfate (SO₄) | ≤ 300 ppm |
EP/BP - Ammonium (NH₄) | ≤ 0.02 % |
EP/BP - Iron (Fe) | ≤ 10 ppm |
EP/BP - Loss on Drying | ≤ 0.5 % |
EP/BP - Ash (sulfated) | ≤ 0.1 % |
Endotoxin Concentration, IU/mg ,For Information Only | |
JP - Assay (C6H9N3O2) (dried basis) | 99.0 - 101.0 % |
JP - Ammonium (NH₄) | ≤ 0.02 % |
JP - Chloride (Cl) | ≤ 0.021 % |
JP - Clarity and Color of Solution | Passes Test |
JP - Heavy Metals (as Pb) | ≤ 10 ppm |
JP - Iron (Fe) | ≤ 10 ppm |
JP - Identification | Passes Test |
JP - Loss on Drying at 105°C | ≤ 0.30 % |
JP- Optical Rotation [Å]²º^D (+) | 11.8 - 12.8 Degree |
JP - Related Substances | Passes Test |
JP - pH | 7.0 - 8.5 |
JP - Residue on Ignition | ≤ 0.10 % |
JP - Sulfate (SO₄) | ≤ 0.028 % |
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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