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102776 Trehaloza dihydrat

Przegląd

Replacement Information

Tabela kluczowych gatunków

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

Products

Numer katalogowyOpakowanie Ilość/opak.
1027761000 Butelka plastikowa 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 Inne substancje ciekłe i stałe
WGKWGK 1 lekkie zanieczyszczenie wody
Disposal3
Względnie niereaktywne odczynniki organiczne należy zbierać w Kategorii A. Odczynniki chlorowcowane należy umieszczać w Kategorii B. Do pozostałości stałych stosować Kategorię 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
Numer katalogowy GTIN
1027761000 04054839467196
1027769013 04054839467202

Documentation

Emprove Dossier

TitleVersion
5.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

Trehaloza dihydrat MSDS

Title

Safety Data Sheet (SDS) 

Trehaloza dihydrat Certificates of Analysis

Numer katalogowy OpakowanieSpecyfikacjaNumer partii
1027761000 Butelka plastikowaDokument ze specyfikacją, w formacie PDF
1027769013 Dokument ze specyfikacją, w formacie PDF

Certificates

Title