D-(+)-Trehalose dihydrate 97.0-102.0% (by HPLC), Multi-Compendial, J.T.Baker®
Supplier: Avantor|
Warning
|
Synonyms:
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
Management of Change (MOC) category = HR
6325-07EA
0
INR
6325-07
6325-08
D-(+)-Trehalose dihydrate 97.0-102.0% (by HPLC), Multi-Compendial, J.T.Baker®
D(+)-Trehalose dihydrate
|
Formula:
C₁₂H₂₂O₁₁·2H₂O MW: 378.33 g/mol |
MDL Number:
MFCD00071594 CAS Number: 6138-23-4 |
Specification Test Results
| GMP Manufactured Product | |
| Meets B.P. Chemical Specifications | |
| Meets E.P. Chemical Specifications | |
| Meets J.P. Chemical Specifications | |
| Meets N.F. Requirements | |
| CAUTION: For Manufacturing, processing or repackaging | |
| Bulk Pharmaceutical Chemical | |
| 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 |
| 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 |
| Gold (Au) | ≤1.67 ppm |
| Iridium (Ir) | ≤0.17 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 |
| 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 forms. |
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