D-Lactose monohydrate, powder NF, Multi-Compendial, J.T.Baker®

Supplier: Avantor

BAKR2250-05EA 373 SGD
BAKR2250-05 BAKR2250-07
D-Lactose monohydrate, powder NF, Multi-Compendial, J.T.Baker®
D-Lactose monohydrate
Formula: C₁₂H₂₂O₁₁·1H₂O
Melting Pt: 223 °C
Storage Temperature: Ambient
MDL Number: MFCD00150747
CAS Number: 64044-51-5
EINECS: 200-559-2

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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
Endotoxin Concentration (EU/g), For Information Only
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.
Internationally Harmonized

SPECIFICATIONS

Environmentally Preferable

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