D-Lactose monohydrate, powder NF, J.T.Baker®
Supplier: Avantor
Synonyms:
D-(+)-Lactose monohydrate
2249-01EA
8264.15
INR
2249-01
2249-05
2249-07
D-Lactose monohydrate, powder NF, J.T.Baker®
D-Lactose monohydrate
Formula:
C₁₂H₂₂O₁₁·1H₂O MW: 360,32 g/mol Melting Pt: 223 °C Storage Temperature: Ambient |
MDL Number:
MFCD00150747 CAS Number: 64044-51-5 EINECS: 200-559-2 |
Specification Test Results
GMP Manufactured Product | Passes Test |
Meets N.F. Requirements | Passes Test |
CAUTION: For Manufacturing, processing or repackaging | Passes Test |
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 Rotation [Å]²º^D (+) | 54.4 - 55.9 Degree |
Microbial Limits - Total Aerobic Count (per g) | ≤100 |
Microbial Limits - Total Combined Molds and Yeasts Count (per g) | ≤50 |
Microbial Limits - Escherichia coli | 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 |
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. |
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