D-Lactose monohydrate, powder NF, J.T.Baker®
Fournisseur: AVANTOR PERFORMANCE MATERIAL LLC
Certificats
A propos de cet article
Synonymes: D-(+)-Lactose monohydrate
Numéro CAS:64044-51-5
:63-42-3
Formule:C₁₂H₂₂O₁₁·1H₂O
MW:360.32 g/mol
Point de Fusion:223 °C
Numéro MDL:MFCD00150747
:Length:
:Width:
:Height:
:Ø
:Thickness:
:Management of Change (MOC) category = R
:Boiling Pt:
:Boiling Pt:
:Melting Pt:
:Melting Pt: 223 °C
:Flash Pt:
:Flash Pt:
:M.W. 360.32 g/mol
:D-Lactose monohydrate
Température d'entreposage:Ambient
EINECS:200-559-2
:M.O.C. Category R
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Résultats des tests de spécification
- 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.:
Résultats des tests de spécification
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