D-Laktos monohydrat, pulver NF, Multi-Compendial, J.T.Baker®
Leverantör: Avantor
Synonyms:
D-(+)-Lactose monohydrate
2250-05EA
3225
SEK
2250-05
2250-07
D-Laktos monohydrat, pulver NF, Multi-Compendial, J.T.Baker®
Laktos monohydrat
|
Formel:
C₁₂H₂₂O₁₁·1H₂O MW: 360,32 g/mol Smältpunkt: 223 °C Storage Temperature: Omgivande |
MDL Number:
MFCD00150747 CAS nummer: 64044-51-5 EINECS: 200-559-2 |
Specifikation testresultat
| GMP Manufactured Product | Passes Test |
| Meets E.P. Chemical Specifications | Passes Test |
| Meets J.P. Chemical Specifications | Passes Test |
| Meets N.F. Requirements | 54.4 - 55.9 Degree |
| Store in airtight container. | ≤100 |
| CAUTION: For Manufacturing, processing or repackaging | ≤50 |
| 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 Rotationα²ºD (+) | 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 Rotationα²ºD (+) | 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 Rotationα²ºD (+) | 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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