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D-Lactose Monohydrat, Pulver NF, Multikompendial, J.T.Baker®
D-Lactose Monohydrat, Pulver NF, Multikompendial, J.T.Baker®
Supplier:  Avantor
Certificatesundefined
D-Lactose Monohydrat, Pulver NF, Multikompendial, J.T.Baker®
Supplier:  Avantor
Certificates

Specifications

  • Environmentally Preferable:

Specifications

Specification Test Results

  • GMP Manufactured Product:
    Passes Test
  • Meets E.P. Chemical Specifications:
    Passes Test
  • Meets J.P. Chemical Specifications:
    Passes Test
  • Meets N.F. Requirements:
    54.4 - 55.9 Degree
  • Store in airtight container.:
    ≤100
  • CAUTION: For Manufacturing, processing or repackaging:
    ≤50
  • Bulk Pharmaceutical Chemical:
    Passes Test
  • NF - Clarity and Color of Solution:
    Passes Test
  • NF - Identification A:
    Passes Test
  • NF - Identification B:
    Passes Test
  • NF - Specific Rotationα²ºD (+):
    54.4 - 55.9 Degree
  • NF - Microbial Limits - Total Aerobic Microbial Counts, cfu/g:
    ≤ 100
  • NF - Microbial Limits - Total Combined Molds and Yeasts Count (per g):
    ≤ 50
  • NF - Microbial Limits - Escherichia Coli and Salmonella:
    Passes Test
  • NF - Acidity or Alkalinity:
    Passes Test
  • NF - Loss on Drying at 80°C:
    ≤ 0.5 %
  • NF - Water (H₂O):
    4.5 - 5.5 %
  • NF - Residue on Ignition:
    ≤ 0.1 %
  • NF - Protein and Light-Absorbing Impurities:
    Passes Test
  • EP - Identification A:
    Passes Test
  • EP - Identification B:
    Passes Test
  • EP - Identification C:
    Passes Test
  • EP - Identification D:
    Passes Test
  • EP - Specific Rotationα²ºD (+):
    54.4 - 55.9 Degree
  • EP - Sulfated Ash:
    ≤ 0.1 %
  • EP - Microbial Limits - Total Aerobic Microbial Count, cfu/g:
    ≤ 100
  • EP- Microbial Limits - Total Combined Molds and Yeasts Count (per g):
    ≤ 50
  • EP - Microbial Limits - Escherichia coli (absent):
    Passes Test
  • EP - Acidity or Alkalinity:
    Passes Test
  • EP - Water (H₂O):
    4.5 - 5.5 %
  • EP - Protein and Light-Absorbing Impurities:
    Passes Test
  • EP - Appearance of Solution:
    Passes Test
  • JP - Clarity and Color of Solution:
    Passes Test
  • JP - Identification A:
    Passes Test
  • JP - Specific Rotationα²ºD (+):
    54.4 - 55.9 Degree
  • JP - Microbial Limits - Total Aerobic Microbial Count, cfu/g:
    ≤ 100
  • JP - Microbial Limits - Total Combined Molds and Yeasts Count (per g):
    ≤ 50
  • JP - Microbial Limits - Escherichia Coli and Salmonella:
    Passes Test
  • JP - Acidity or Alkalinity:
    Passes Test
  • JP - Water (H₂O):
    4.5 - 5.5 %
  • JP - Loss on Drying at 80°C:
    ≤ 0.5 %
  • JP - Residue on Ignition:
    ≤ 0.10 %
  • JP - Heavy Metals (as Pb):
    ≤ 5 ppm
  • JP - Protein and Light-Absorbing Impurities:
    Passes Test

Specification Test Results

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