Lactose, Monohydrate, Powder, NF, Multi-Compendial, J.T.Baker®
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Lactose, Monohydrate, Powder, NF, Multi-Compendial, J.T.Baker®
Formula: C12H22O11?H2O
Formula Weight: 360.32
| TEST |
SPECIFICATION |
| GMP Manufactured Product |
| Meets N.F. Requirements |
| Clarity and Color of Solution |
Passes Test |
| Identification A |
Passes Test |
| Identification B |
Passes Test |
| Identification C |
Passes Test |
| Specific Rotation [a]20D |
54.4 - 55.9 ? |
| Microbial Limits: |
| Total Aerobic Microbial Count, cfu/g |
max. 100 |
Total Combined Molds and Yeasts
Count (per g) |
max. 50 |
| Escherichia Coli and Salmonella |
Passes Test |
| Acidity or Alkalinity |
Passes Test |
| Loss on Drying at 80?C |
max. 0.5 % |
| Residue on Ignition |
max. 0.1 % |
| Heavy Metals (as Pb) |
max. 5 ppm |
| Protein and Light-absorbing Impurities |
Passes Test |
| Meets EP Chemical Specifications |
| Identification A |
Passes Test |
| Identification B |
Passes Test |
| Identification C |
Passes Test |
| Identification D |
Passes Test |
| Specific Rotation [a]20D |
54.4 - 55.9 ? |
| Sulfated Ash |
max. 0.1 % |
| Microbial Limits: |
| Total Aerobic Microbial Count, cfu/g |
max. 100 |
| Escherichia coli (absent) |
Passes Test |
| Acidity or Alkalinity |
Passes Test |
| Water (H2O) |
4.5 - 5.5 % |
| Heavy Metals (as Pb) |
max. 5 ppm |
| Protein and Light-absorbing Impurities |
Passes Test |
| Appearance of Solution |
Passes Test |
| Meets JP Chemical Specifications |
| Clarity and Color of Solution |
Passes Test |
| Identification A |
Passes Test |
| Specific Rotation [a]20D |
54.4 - 55.9 ? |
| Microbial Limits: |
| Total Aerobic Microbial Count, cfu/g |
max. 100 |
Total Combined Molds and Yeasts
Count (per g) |
max. 50 |
| Escherichia Coli and Salmonella |
Passes Test |
| Acidity or Alkalinity |
Passes Test |
| Loss on Drying at 80?C |
max. 0.5 % |
| Residue on Ignition |
max. 0.1 % |
| Heavy Metals (as Pb) |
max. 5 ppm |
| Protein and Light-absorbing Impurities |
Passes Test |
| |
| Endotoxin Concentration (EU/g) |
Actual Value Reported |
| |
| No Class 1,2,3 or other solvents are used or produced in the manufacturing or purification of the product. |
| Bulk Pharmaceutical Chemical |
| CAUTION: For manufacturing, processing or repacking. |
| For a Certificate of Lot Analysis, visit www.avantormaterials.com |
| |
| Internationally Harmonized |
| NOTE: This product is not derived from cattle from Bovine SpongiformEncephalopathy-infected countries. Only domestic cattle are used. |
| Store in airtight container. |
| CAS Number |
64044-51-5 |
| Merck Index |
14,5343 |
| HTS Number |
1702190000 |
| Specific Gravity |
1L = 1.53 Kg |
| Storage Color Code |
Green |
| Management of Change |
R |