D (+)-Trehalosdihydrat 97.0-102.0% NF, HPLE, multi-compendial parenteral grade, J.T.Baker®
Leverantör: Avantor|
Varning
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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
6324-06EA
31600
SEK
6324-06
6324-05
6324-07
D (+)-Trehalosdihydrat 97.0-102.0% NF, HPLE, multi-compendial parenteral grade, J.T.Baker®
D (+)-Trehalosdihydrat
Residual solvents: Only the Class 2 solvent methanol and the Class 3 solvent ethanol are likely to be present.
- High purity
- Low endotoxin
Metallic residues: No metal catalysts or metal reagents, as defined by EMA Guideline EMEA/CHMP/SWP/4446/2000 , are used in the production of this material.
Certifikat: Meets B.P.; E.P.; J.P. chemical specifications and N.F. requirements.
Observera: For manufacturing, processing or repackaging.
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Formel:
C₁₂H₂₂O₁₁·2H₂O MW: 378,33 g/mol Smältpunkt: 97…99 °C |
MDL Number:
MFCD00071594 CAS nummer: 6138-23-4 |
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Specifikation testresultat
| 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° |
| Endotoxin Concentration, EU/g | ≤0.6 |
| Trace Impurities - Aluminum (Al), For Information Only |
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| 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 - Manganese (Mn), For Information Only | For Information Only |
| Trace Impurities - Mercury (Hg), For Information Only | For Information Only |
| Trace Impurities - Molybdenum (Mo), For Information Only | |
| Trace Impurities - Nickel (Ni), For Information Only | |
| Trace Impurities - Osmium (Os), For Information Only | |
| Trace Impurities - Palladium (Pd), For Information Only | |
| Trace Impurities - Platinum (Pt), For Information Only | |
| Trace Impurities - Rhodium (Rh), For Information Only | |
| Trace Impurities - Ruthenium (Ru), For Information Only | |
| Trace Impurities - Vanadium (V), For Information Only | |
| Trace Impurities - Zinc (Zn), For Information Only | |
| Residual Methanol | ≤3000 ppm |
| Residual Ethanol | ≤5000 ppm |
| Residual Isopropanol | ≤5000 ppm |
| Cyanide (CN) | ≤100 ppb |
| 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 Frms |
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