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102776 Trehalose dihydrate

Ph Eur,ChP,NF,JP

Trehalose dihydrate : FDS (Fiches de données de sécurité), certificats d’analyse (CoA) et de qualité (CoQ), dossiers, brochures et autres documents disponibles.

Synonymes: 1-O-alpha-D-Glucopyranosyl-alpha-D-glucopyranoside

CAS #: 6138-23-4 EC Number: 202-739-6 Molar Mass: 378.33 g/mol Grade: Ph Eur,ChP,NF,JP
102776
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Tableau de caractéristiques principal

CAS #EC NumberMolar MassGrade Value
6138-23-4202-739-6378.33 g/molPh Eur,ChP,NF,JP

Products

RéférenceConditionnement Qté
1027761000 Flacon plastique 1 kg
1027769013 12 kg
Description
Catalogue Number102776
Synonyms1-O-alpha-D-Glucopyranosyl-alpha-D-glucopyranoside
References
Product Information
CAS number6138-23-4
EC number202-739-6
GradePh Eur,ChP,NF,JP
Molar Mass378.33 g/mol
HS Code2940 00 99
Quality LevelMQ500
Applications
Biological Information
Physicochemical Information
Melting Point96.5 - 97.5 °C
Dimensions
Materials Information
Toxicological Information
Safety Information according to GHS
Storage class10 - 13 Other liquids and solids
WGKWGK 1 slightly hazardous to water
Disposal3
Relatively unreactive organic reagents should be collected in container A. If halogenated, they should be collected in container B. For solid residues use container C.
Safety Information
Product Usage Statements
Storage and Shipping Information
StorageNoTempLimit
Packaging Information
Transport Information
Supplemental Information
Specifications
Descriptionwhite to almost white, crystalline powder
Assay (HPLC, calc. on anhydrous substance)98.0 - 101.0 %
Identity (IR)conforms
Identity (retention time, ChP)conforms
Appearance of solution (10 %, water)passes test
Color and clarity of solution, Absorbance (720nm; 33%; 10cm; water)≤ 0.033
Color and clarity of solution, Absorbance (420 - 720nm; 33%; 10cm; water)≤ 0.067
pH-value (10 %; water)4.5 - 6.5
Spec. rotation (α 20/D; 10 %; water; calc. on anhydrous substance)+197 - +201 °
Chloride (Cl)≤ 125 ppm
Sulfate (SO₄)≤ 200 ppm
Nitrogen (N)≤ 0.005 %
Heavy metals (as Pb)≤ 5 ppm
Related substances (HPLC) (Glucose (impurity A))≤ 0.5
Related substances (HPLC) (Maltotriose (impurity B))≤ 0.2
Related substances (HPLC) (unspecified impurities single)≤ 0.2
Related substances (HPLC) (Sum of all impurities)≤ 0.5
Residual solvents (ICHQ3C) of class 2 (Methanol)≤ 300
Other residual solvents (ICH Q3C)excluded by manufacturing process
Soluble starch (Ph Eur, ChP, NF)passes test
Dextrin, soluble starch and sulfite (JP)passes test
Residue on ignition≤ 0.1
Water (according to Karl Fischer)9.0 - 11.0 %
Endotoxins< 0.3
Total aerobic microbial count≤ 100
Total yeast and mould count≤ 10
E.coliAbsent in 1 g
Salmonella spp.Absent in 10 g
Total aerobic microbial count (ChP)≤ 10²
Total yeast and mould count (ChP)≤ 10¹
E.coli (ChP)Absent in 1 g
Salmonella spp. (ChP)Absent in 10 g
DNases (Exo- and endonucleases) (not detectable)passes test
RNases (not detectable)passes test
Elemental impurity specifications have been set considering ICH Q3D (Guideline for Elemental Impurities).
Class 1-3 elements are not likely to be present above the ICH Q3D option 1 limit, unless specified and indicated (*).
Corresponds to Ph.Eur.,NF,JP
Global Trade Item Number
Référence GTIN
1027761000 04054839467196
1027769013 04054839467202

Documentation

Material Qualification Dossier

TitreVersion
5.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

Trehalose dihydrate FDS

Titre

Fiche de données de sécurité des matériaux (FDS) 

Trehalose dihydrate Certificats d'analyse

Référence ConditionnementSpécificationNuméro de lot
1027761000 Flacon plastiqueDocument de spécification PDF
1027769013 Document de spécification PDF

Certificats

Titre