D-Lactose monohydrate, powder NF, J.T.Baker®

Supplier: AVANTOR PERFORMANCE MATERIAL LLC

Synonyms: D-(+)-Lactose monohydrate

Management of Change (MOC) category = R

BAKR2249-07 BAKR2249-07 BAKR2249-01 BAKR2249-05 BAKR2249-01 BAKR2249-05
JT2249-7EA 1637.79 USD
CAJT2249-7 CAJT2249-5 JT2249-7 CAJT2249-1 JT2249-5 JT2249-1
D-Lactose monohydrate, powder NF, J.T.Baker®
D-Lactose monohydrate
Formula: C₁₂H₂₂O₁₁·1H₂O
MW: 360.32 g/mol
Melting Pt: 223 °C
Storage Temperature: Ambient
MDL Number: MFCD00150747
CAS Number: 64044-51-5
EINECS: 200-559-2

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Specification Test Results

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.

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