D-(+)-Trehalose dihydrate 97.0-102.0% (by HPLC), Multi-Compendial, J.T.Baker®
: Avantor
:6138-23-4
:
:C₁₂H₂₂O₁₁·2H₂O
:MFCD00071594
:378.33 g/mol
:Management of Change (MOC) category = HR
- Endotoxin Concentration, EU/g:≤0.6
- Arsenic (As):≤0.25 ppm
- Cadmium (Cd):≤0.03 ppm
- Mercury (Hg):≤0.05 ppm
- Lead (Pb):≤0.08 ppm
- Cobalt (Co):≤0.08 ppm
- Nickel (Ni):≤0.33 ppm
- Vanadium (V):≤0.17 ppm
- Silver (Ag):≤0.17 ppm
- Iridium (Ir):≤0.17 ppm
- Gold (Au):≤1.67 ppm
- Osmium (Os):≤0.17 ppm
- Palladium (Pd):≤0.17 ppm
- Platinum (Pt):≤0.17 ppm
- Rhodium (Rh):≤0.17 ppm
- Ruthenium (Ru):≤0.17 ppm
- Selenium (Se):≤1.33 ppm
- Thallium (Tl):≤0.13 ppm
- Barium (Ba):≤11.67 ppm
- Chromium (Cr):≤18.33 ppm
- Copper (Cu):≤5.00 ppm
- Lithium (Li):≤4.17 ppm
- Molybdenum (Mo):≤25.00 ppm
- Antimony (Sb):≤1.50 ppm
- Tin (Sn):≤10.00 ppm
- Aluminum (Al):≤10.00 ppm
- Residual Methanol:≤500 ppm
- Residual Ethanol:≤833 ppm
- Residual Isopropanol:≤833 ppm
- 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:≤0.05 %
- 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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