D-(+)-Trehalose dihydrate 97.0-102.0% (by HPLC) NF, HPLE, multi-compendial parenteral grade multi-compendial, J.T.Baker®
: Avantor
: Mycose, α,α-Trehalose, 1-O-α-D-Glucopyranosyl-α-D-glucopyranoside, α-D-Glucopyranosyl-α-D-glucopyranoside, (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
:6138-23-4
:
:C₁₂H₂₂O₁₁·2H₂O
:MFCD00071594
:378.33 g/mol
:97…99 °C
- Environmentally Preferable:
- 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 - Mercury (Hg), For Information Only:For Information Only
- Trace Impurities - Manganese (Mn), For Information Only:For Information Only
- Residual Methanol:≤3000 ppm
- Residual Ethanol:≤5000 ppm
- Residual Isopropanol:≤5000 ppm
- Cyanide (CN):≤100 ppb
- 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°
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