D-(+)-Trehalose dihydrate 97.0-102.0% (by HPLC) NF, HPLE, multi-compendial parenteral grade, J.T.Baker®
: 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
:Management of Change (MOC) category = R
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- Environmentally Preferable:
- Endotoxin Concentration, EU/g:≤0.6
- Residual Methanol:≤3000 ppm
- Residual Ethanol:≤5000 ppm
- Residual Isopropanol:≤5000 ppm
- Cyanide (CN):≤100 ppb
- 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
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