D-(+)-Trehalose dihydrate 97.0-102.0% (by HPLC), Multi-Compendial, J.T.Baker®

: Avantor

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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