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-glucopyranoside
, Mycose
, α-D-Glucopyranosyl-α-D-glucopyranoside
, α,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 |
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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