D-Lactose monohydrate, powder NF, J.T.Baker®
Supplier: AVANTOR PERFORMANCE MATERIAL LLC
Synonyms:
D-(+)-Lactose monohydrate
Management of Change (MOC) category = R
2249-07
BAKR2249-07
2249-01
2249-05
BAKR2249-01
BAKR2249-05
CAJT2249-7EA
2704.15
CAD
CAJT2249-7
CAJT2249-5
JT2249-7
CAJT2249-1
JT2249-5
JT2249-1
D-Lactose monohydrate, powder NF, J.T.Baker®
D-Lactose monohydrate
|
Formula:
C₁₂H₂₂O₁₁·1H₂O MW: 360.32 g/mol Melting Pt: 223 °C |
MDL Number:
MFCD00150747 CAS Number: 64044-51-5 |
Specification Test Results
| GMP Manufactured Product | |
| Meets N.F. Requirements | |
| CAUTION: For Manufacturing, processing or repackaging | |
| Bulk Pharmaceutical Chemical | |
| 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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