L(+)-Valine 98.5-101.5% (dried basis) USP, FCC, Multi-Compendial, Macron Fine Chemicals™
Supplier: Avantor Performance Materials
Synonyms:
H-Val-OH, Valine, (S)-(+)-Valine
4936-06EA
21041.49
INR
4936-06
4936-09
L(+)-Valine 98.5-101.5% (dried basis) USP, FCC, Multi-Compendial, Macron Fine Chemicals™
L(+)-Valine
Formula:
C₅H₁₁NO₂ MW: 117,15 g/mol |
MDL Number:
MFCD00064220 CAS Number: 72-18-4 |
Specification Test Results
Meets B.P. Chemical Specifications | |
GMP Manufactured Product | |
Meets E.P. Chemical Specifications | |
Meets J.P. Chemical Specifications | |
Meets U.S.P Requirements | |
CAUTION: For Manufacturing, processing or repackaging | |
Bulk Pharmaceutical Chemical | |
USP - Assay (C₅H₁₁NO₂) (dried basis) | 98.5 - 101.5 % |
USP - Identification | Passes Test |
USP - Specific Rotation [Å]²⁵ ^D (+) | 26.6 - 28.8 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 - Related Compounds - Individual Impurities | ≤0.5 % |
USP - Related Compounds - Total Impurities | ≤2.0 % |
EP/BP - Assay (C₅H₁₁NO₂) (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 (+) | 26.5 - 29.0 Degree |
EP/BP-Ninhydrin-Positive Substances-Impurity B | ≤0.4 % |
EP/BP-Ninhydrin-Positive Substances-Each | ≤0.2 % |
EP/BP-Ninhydrin-Positive Substances-Total Impurities | ≤1.0 % |
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 % |
JP - Assay (C₅H₁₁NO₂) (dried basis) | 98.5 - 101.0 % |
JP - Identification | Passes Test |
JP - Optical Rotation (+) | 26.5 - 29.0 Degree |
JP - pH | 5.5 - 6.5 |
JP - Clarity and Color of Solution | Passes Test |
JP - Chloride (Cl) |
|
JP - Sulfate (SO₄) |
|
JP - Ammonium (NH₄) |
|
JP - Heavy Metals (as Pb) |
|
JP - Arsenic (As) |
|
JP - Related Substances | Passes Test |
JP - Loss on Drying at 105°C |
|
JP - Residue on Ignition |
|
Endotoxin Concentration, IU/mg, For Information Only |
|
Only Class 2 Solvents (Methanol) are likely to be present. All are |
|
below Option 1 limits. | 98.5 - 101.0 % |
Metallic Residues: No metal catalysts or metal reagents, as defined by | Passes Test |
EMA Guideline EMEA/CHMP/SWP/4446/2000 , are used in the production of | 26.5 - 29.0 Degree |
this material. | 5.5 - 6.5 |
Endotoxin Concentration, IU/mg | For Information Only |
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