D-(+)-Trehalose dihydrate 97.0-102.0% (by HPLC) NF, HPLE, Multi-compendial parenteral grade, J.T.Baker®

Supplier: AVANTOR PERFORMANCE MATERIAL LLC
Warning

Synonyms: 1-O-α-D-Glucopyranosyl-α-D-glucopyranosideMycoseα-D-Glucopyranosyl-α-D-glucopyranosideα,α-Trehalose(2R,2'R,3S,3'S,4S,4'S,5R,5'R,6R,6'R)-6,6'-Oxybis(2-(hydroxymethyl)tetrahydro-2H-pyran-3,4,5-triol) dihydrate

Management of Change (MOC) category = R

BAKR6324-QM BAKR6324-05 BAKR6324-06 BAKR6324-07 BAKR6324-06 BAKR6324-07 BAKR6324-09 BAKR6324-QM BAKR6324-09 BAKR6324-05
JT6324-07CS 15287.81 USD
JT6324-07 JT6324-06 CAJT6324-09 CAJT6324-07 JT6324-09 CAJT6324-06 CAJT6324-5 CAJT6324-QM JT6324-QM JT6324-5
D-(+)-Trehalose dihydrate 97.0-102.0% (by HPLC) NF, HPLE, Multi-compendial parenteral grade, J.T.Baker®
D(+)-Trehalose dihydrate

  • High purity
  • Low endotoxin


Caution: For manufacturing, processing or repackaging

Formula: C₁₂H₂₂O₁₁·2H₂O
MW: 378.33 g/mol
Melting Pt: 97…99 °C
MDL Number: MFCD00071594
CAS Number: 6138-23-4
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Specification Test Results

Meets N.F. Requirements
GMP Manufactured Product
Meets B.P. Chemical Specifications
Meets J.P. Chemical Specifications
Meets E.P. Chemical Specifications
CAUTION: For Manufacturing, processing or repackaging
Bulk Pharmaceutical Chemical
NF - Assay (HPLC) 97.0 - 102.0 %
NF - Chloride (Cl) ≤0.0125 %
NF - Color and Clarity of Solution: Absorbance @ 720 nm ≤0.050
NF - Color and Clarity of Solution, Absorption difference ≤0.100
NF - Identification A Passes Test
NF - Identification B Passes Test
NF - Identification C Passes Test
NF - Microbial Limits: TAMC (cfu/g) ≤100 cfu/g
NF - Microbial Limits: TYMC (cfu/g) ≤100 cfu/g
NF - Microbial Limits: E. coli None Detected
NF - Microbial Limits: Salmonella None Detected
NF - Nitrogen content ≤0.005 %
NF - pH of 10% solution 4.5 - 6.5
NF - Related Substances - total peaks eluting before trehalose ≤0.5 %
NF - Related Substances - total peaks eluting after trehalose ≤0.5 %
NF - Residue on Ignition ≤0.10 %
NF - Soluble starch Passes Test
NF - Specific Optical Rotation, anhydrous [Å]²º^D (+) 197 - 201 Degree
NF - Sulfate (SO₄) ≤0.0200 %
NF - Water (by Karl Fischer titration) 9.0 - 11.0 %
EP/BP - Appearance of Solution Passes Test
EP/BP - Assay (LC) 97.0 - 102.0 %
EP/BP - Chloride (Cl) ≤125 ppm
EP/BP - Identification A Passes Test
EP/BP - Identification B Passes Test
EP/BP - Identification C Passes Test
EP/BP - Microbial Limits: TAMC (cfu/g) ≤100 cfu/g
EP/BP - Microbial Limits: TYMC (cfu/g) ≤100 cfu/g
EP/BP - Microbial Limits: E. coli None Detected
EP/BP - Microbial Limits: Salmonella None Detected
EP/BP - pH of 10% solution 4.5 - 6.5
EP/BP - Related Substances - Impurity A ≤0.5 %
EP/BP - Related Substances - Impurity B ≤0.5 %
EP/BP - Related Substances - Unspecified Impurities, each ≤0.2 %
EP/BP - Related Substances - Total Impurities ≤1.0 %
EP/BP - Soluble starch Passes Test
EP/BP - Specific Optical Rotation, anhydrous [Å]²º^D (+) 197 - 201 Degree
EP/BP - Sulfate (SO₄) ≤200 ppm
EP/BP - Sulfated ash ≤0.1 %
EP/BP - Water (by Karl Fischer 9.0 - 11.0 %
JP - Assay (LC) 98.0 - 101.0 %
JP - Chloride (Cl) ≤0.018 %
JP - Dextrin, soluble starch and sulfite Passes Test
JP - Heavy Metals (as Pb) ≤5 ppm
JP - Identification 1 Passes Test
JP - Identification 2 Passes Test
JP - Identification 3 Passes Test
JP - Nitrogen ≤0.005 %
JP - pH of 10% solution 4.5 - 6.5
JP - Related Substances - total peaks eluting before trehalose ≤0.5 %
JP - Related Substances - total peaks eluting after trehalose ≤0.5 %
JP - Residue on Ignition ≤0.1 %
JP - Specific Optical Rotation, anhydrous [Å]²º^D (+) 197 - 201 Degree
JP - Sulfate (SO₄) ≤0.024 %
JP - Water (by Karl Fischer titration) 9.0 - 11.0 %
Appearance (white to off white powder) Passes Test
Conductivity, uS cm-1 ≤15
Reducing Sugars Passes Test
Glucose Area% ≤0.5 %
Microbial Testing - Staphylococcus aureus (USP) None Detected
Microbial Testing - Pseudomonas aeruginosa (USP) None Detected
Specific Optical Rotation, dihydrate [Å]²º^D (+) 177.5 - 180.5 Degree
Endotoxin Concentration, EU/g ≤0.6
Trace Impurities - Aluminum (Al), For Information Only
Trace Impurities - Arsenic (As), For Information Only
Trace Impurities - Cadmium (Cd), For Information Only
Trace Impurities - Chromium (Cr), For Information Only
Trace Impurities - Copper (Cu), For Information Only
Trace Impurities - Iridium (Ir), For Information Only
Trace Impurities - Iron (Fe), For Information Only
Trace Impurities - Lead (Pb), For Information Only
Trace Impurities - Manganese (Mn), For Information Only
Trace Impurities - Mercury (Hg), For Information Only
Trace Impurities - Molybdenum (Mo), For Information Only
Trace Impurities - Nickel (Ni), For Information Only
Trace Impurities - Osmium (Os), For Information Only
Trace Impurities - Palladium (Pd), For Information Only
Trace Impurities - Platinum (Pt), For Information Only
Trace Impurities - Rhodium (Rh), For Information Only
Trace Impurities - Ruthenium (Ru), For Information Only
Trace Impurities - Vanadium (V), For Information Only
Trace Impurities - Zinc (Zn), For Information Only
Residual Methanol ≤3000 ppm
Residual Ethanol ≤5000 ppm
Residual Isopropanol ≤5000 ppm
Cyanide (CN) ≤100 ppb
Residual Solvents: Only the Class 2 solvent Methanol and the Class 3
Solvents Ethanol and Isopropanol are likely to be present. Each is
tested and the concentration reported for each batch.
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.
Plant Derived.
Suitable for use in the manufacture of parenteral dosage forms.

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