Macron™ 4932-09 L-Arginine, USP Grade, Multi-Compendial Grade, 50Kg Poly Drum
- 50Kg Poly Drum
- Manufacturer Part No: MK-4932-09
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Details
Product Specifications
TEST | SPECIFICATION |
Food GMP Manufactured Product | |
GMP Manufactured Product | |
Meets B.P. Chemical Specifications | |
Meets E.P. Chemical Specifications | |
Meets F.C.C. Requirements | |
Meets U.S.P Requirements | |
CAUTION: For Manufacturing, processing or repackaging | |
Bulk Food Chemical | |
Bulk Pharmaceutical Chemical | |
USP - Assay (C₆H₁₄N₄O₂) (dried basis) | 98.5 - 101.5 % |
USP - Identification | Passes Test |
USP - Specific Rotation [Å]²⁵ ^D (+) | 26.3 - 27.7 Degree |
USP - Loss on Drying at 105°C | <= 0.5 % |
USP - Chloride (Cl) | <= 0.05 % |
USP - Residue on Ignition | <= 0.3 % |
USP - Sulfate (SO₄) | <= 0.03 % |
USP - Iron (Fe) | <= 0.003 % |
USP - Heavy Metals (as Pb) | <= 0.0015 % |
USP - Related Compounds - Individual Impurities | <= 0.5 % |
USP - Related Compounds - Total Impurities | <= 2.0 % |
FCC - Assay (C₆H₁₄N₄O₂) (dried basis) | 98.5 - 101.5 % |
FCC - Identification | Passes Test |
FCC - Lead (Pb) | <= 5 mg/kg |
FCC - Loss on Drying at 105°C | <= 1.0 % |
FCC - Residue on Ignition | <= 0.2 % |
FCC - Specific Rotation [Å]²º^D (+) | 26.0 - 27.9 Degree |
EP/BP - Assay (C₆H₁₄N₄O₂) (dried basis) | 98.5 - 101.0 % |
EP/BP - Identification A | Passes Test |
EP/BP - Identification C | Passes Test |
EP/BP - Appearance of Solution | Passes Test |
EP/BP - Specific Rotation [Å]²º^D (+) | 25.5 - 28.5 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 - Heavy Metals (as Pb) | <= 10 ppm |
EP/BP - Loss on Drying | <= 0.5 % |
EP/BP - Ash (sulfated) | <= 0.1 % |
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. | |
Metallic Residues: No metal catalysts or metal reagents, as defined by | |
EMA Guideline EMEA/CHMP/SWP/4446/2000 , are used in the production of | |
this material. |
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Product Specifications
TEST | SPECIFICATION |
Food GMP Manufactured Product | |
GMP Manufactured Product | |
Meets B.P. Chemical Specifications | |
Meets E.P. Chemical Specifications | |
Meets F.C.C. Requirements | |
Meets U.S.P Requirements | |
CAUTION: For Manufacturing, processing or repackaging | |
Bulk Food Chemical | |
Bulk Pharmaceutical Chemical | |
USP - Assay (C₆H₁₄N₄O₂) (dried basis) | 98.5 - 101.5 % |
USP - Identification | Passes Test |
USP - Specific Rotation [Å]²⁵ ^D (+) | 26.3 - 27.7 Degree |
USP - Loss on Drying at 105°C | <= 0.5 % |
USP - Chloride (Cl) | <= 0.05 % |
USP - Residue on Ignition | <= 0.3 % |
USP - Sulfate (SO₄) | <= 0.03 % |
USP - Iron (Fe) | <= 0.003 % |
USP - Heavy Metals (as Pb) | <= 0.0015 % |
USP - Related Compounds - Individual Impurities | <= 0.5 % |
USP - Related Compounds - Total Impurities | <= 2.0 % |
FCC - Assay (C₆H₁₄N₄O₂) (dried basis) | 98.5 - 101.5 % |
FCC - Identification | Passes Test |
FCC - Lead (Pb) | <= 5 mg/kg |
FCC - Loss on Drying at 105°C | <= 1.0 % |
FCC - Residue on Ignition | <= 0.2 % |
FCC - Specific Rotation [Å]²º^D (+) | 26.0 - 27.9 Degree |
EP/BP - Assay (C₆H₁₄N₄O₂) (dried basis) | 98.5 - 101.0 % |
EP/BP - Identification A | Passes Test |
EP/BP - Identification C | Passes Test |
EP/BP - Appearance of Solution | Passes Test |
EP/BP - Specific Rotation [Å]²º^D (+) | 25.5 - 28.5 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 - Heavy Metals (as Pb) | <= 10 ppm |
EP/BP - Loss on Drying | <= 0.5 % |
EP/BP - Ash (sulfated) | <= 0.1 % |
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. | |
Metallic Residues: No metal catalysts or metal reagents, as defined by | |
EMA Guideline EMEA/CHMP/SWP/4446/2000 , are used in the production of | |
this material. |