D-Lactose monohydrate, powder NF, Multi-Compendial, J.T.Baker®
Supplier: AVANTOR PERFORMANCE MATERIAL LLC
Synonyms:
D-(+)-Lactose monohydrate
Management of Change (MOC) category = R
BAKR2250-05
2250-05
BAKR2250-07
2250-07
CAJT2250-7EA
2125.83
CAD
JT2250-7
JT2250-5
CAJT2250-7
CAJT2250-5
D-Lactose monohydrate, powder NF, Multi-Compendial, 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
| Meets J.P. Chemical Specifications | |
| Meets N.F. Requirements | |
| GMP Manufactured Product | |
| Meets E.P. Chemical Specifications | |
| Store in airtight container. | |
| 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 |
| 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 Rotation [Å]²º^D (+) | 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 Rotation [Å]²º^D (+) | 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 |
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