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L-Arginine hydrochloride 98.5-101.5% (dried basis) USP, FCC, Multi-Compendial, Macron Fine Chemicals™
L-Arginine hydrochloride 98.5-101.5% (dried basis) USP, FCC, Multi-Compendial, Macron Fine Chemicals™
Supplier:  MACRON AVANTOR BRAND
Certificatesundefined
L-Arginine hydrochloride 98.5-101.5% (dried basis) USP, FCC, Multi-Compendial, Macron Fine Chemicals™
Supplier:  MACRON AVANTOR BRAND
Certificates

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Specification Test Results

  • GMP Manufactured Product:
    —
  • Meets B.P. Chemical Specifications:
    —
  • Meets E.P. Chemical Specifications:
    —
  • Meets J.P. Chemical Specifications:
    —
  • Meets U.S.P Requirements:
    —
  • Store in well-closed,light-resistant containers:
    —
  • CAUTION: For Manufacturing, processing or repackaging:
    —
  • Bulk Pharmaceutical Chemical:
    —
  • USP - Assay (C₆H₁₄N₄O₂·HCl) (dried basis):
    98.5 - 101.5 %
  • USP - Identification:
    Passes Test
  • USP - Specific Rotation [Å]²º^D (+):
    21.4 - 23.6 Degree
  • USP - Loss on Drying at 105°C:
    ≤ 0.2 %
  • USP - Residue on Ignition:
    ≤ 0.1 %
  • USP - Sulfate (SO₄):
    ≤ 0.03 %
  • USP - Related Compounds - Individual Impurities:
    ≤ 0.5 %
  • USP - Related Compounds - Total Impurities:
    ≤ 2.0 %
  • USP - Chloride (Cl):
    16.5 - 17.1 %
  • FCC - Assay (C₆H₁₄N₄O₂·HCl) (dried basis):
    98.5 - 101.5 %
  • FCC - Identification:
    Passes Test
  • FCC - Loss on Drying:
    ≤ 0.3 %
  • FCC - Residue after Ignition:
    ≤ 0.10 %
  • FCC - Specific Rotation [Å]²º^D (+):
    21.3 - 23.5 Degree
  • FCC - Lead (Pb):
    ≤ 5 mg/kg
  • EP/BP - Assay (C₆H₁₄N₄O₂·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 - 23.5 Degree
  • EP/BP-Ninhydrin-Positive Substances-Each:
    ≤ 0.2 %
  • EP/BP-Ninhydrin-Positive Substances-Total Impurities:
    ≤ 0.5 %
  • 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 (C₆H₁₄N₄O₂·HCl) (dried basis):
    98.5 - 101.0 %
  • JP - Identification:
    Passes Test
  • JP - Optical Rotation (+):
    21.5 - 23.5 Degree
  • JP - pH (1 in 10):
    4.7 - 6.2
  • JP - Clarity and Color of Solution:
    Passes Test
  • JP - Sulfate (SO₄):
    ≤ 0.028 %
  • JP - Ammonium (NH₄):
    ≤ 0.02 %
  • JP - Heavy Metals (as Pb):
    ≤ 20 ppm
  • JP - Arsenic (As):
    ≤ 2 ppm
  • JP - Related Substances:
    Passes Test
  • JP - Loss on Drying at 105°C:
    ≤ 0.20 %
  • JP - Residue after Ignition:
    ≤ 0.10 %
  • Endotoxin Concentration, IU/mg, For Information Only:
    ≤ 20 ppm
  • No Class 1,2,3 or other solvents are used or produced in the:
    ≤ 2 ppm
  • manufacturing or purification of the product.:
    Passes Test
  • Elemental Impurities (USP (232), EP 5.20) - Information on elemental:
    ≤ 0.10 %
  • impurities for this product is available on the associated Product:
    —

Specification Test Results

Related Information