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

Supplier: Avantor
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6324-06EA 2845.81 EUR
6324-06 6324-05 6324-07
D-(+)-Trehalose dihydrate 97.0-102.0% (by HPLC) NF, HPLE, multi-compendial parenteral grade, J.T.Baker®
D(+)-Trehalose dihydrate

Residual solvents: Only the Class 2 solvent methanol and the Class 3 solvent ethanol are likely to be present.


  • High purity
  • Low endotoxin


Metallic residues: No metal catalysts or metal reagents, as defined by EMA Guideline EMEA/CHMP/SWP/4446/2000 , are used in the production of this material.


Certifikace: Meets B.P.; E.P.; J.P. chemical specifications and N.F. requirements.


Upozornení: For manufacturing, processing or repackaging.

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

GMP Manufactured Product
Meets BP. Chemical Specifications
Meets EP Chemical Specifications
Meets JP Chemical Specifications
Meets NF Requirements
CAUTION: For Manufacturing, Processing or Repackaging
Bulk Pharmaceutical Chemical 97.0 - 102.0 %
NF - Assay (HPLC) 97.0 - 102.0%
NF - Chloride (Cl) ≤0.0125%
NF - Colour and Clarity of Solution: Absorbance at 720 nm ≤0.050
NF - Colour 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 α²ºD (+) 197 - 201°
NF - Sulphate (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 α²ºD (+) 197 - 201°
EP/BP - Sulphate (SO₄) ≤200 ppm
EP/BP - Sulphated Ash ≤0.1%
EP/BP - Water (by Karl Fischer Titration) 9.0 - 11.0 %
JP - Assay (LC) 98.0 - 101.0%
JP - Chloride (Cl) ≤0.018%
JP - Dextrin, Soluble Starch and Sulphite 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 α²ºD (+) 197 - 201°
JP - Sulphate (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 α²ºD (+) 177.5 - 180.5°
Endotoxin Concentration, EU/g ≤0.6
Trace Impurities - Aluminum (Al), For Information Only = 0.6
Trace Impurities - Arsenic (As), For Information Only For Information Only
Trace Impurities - Cadmium (Cd), For Information Only For Information Only
Trace Impurities - Chromium (Cr), For Information Only For Information Only
Trace Impurities - Copper (Cu), For Information Only For Information Only
Trace Impurities - Iridium (Ir), For Information Only For Information Only
Trace Impurities - Iron (Fe), For Information Only For Information Only
Trace Impurities - Lead (Pb), For Information Only For Information Only
Trace Impurities - Manganese (Mn), For Information Only For Information Only
Trace Impurities - Mercury (Hg), For Information Only 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 Frms

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