Lactose, Monohydrate, Powder, NF, J.T.Baker®
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Lactose, Monohydrate, Powder, NF, J.T.Baker®
Formula: C12H22O11·H2O
Formula Weight: 360.32
| TEST |
SPECIFICATION |
| 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. |
| CAS Number |
64044-51-5 |
| Merck Index |
14,5343 |
| HTS Number |
1702190000 |
| Specific Gravity |
1L = 1.53kg |
| Storage Color Code |
Green |
| Management of Change |
R |