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111597 Parteck® SI 400 LEX (sorbitol)

EMPROVE® EXPERT Ph Eur,BP,NF,JP

Parteck® SI 400 LEX (sorbitol) MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.

Synonyms: D-Glucitol

CAS #: 50-70-4 EC Number: 200-061-5 Molar Mass: 182.17 g/mol Hill Formula: C₆H₁₄O₆ Grade: Ph Eur,BP,NF,JP
111597
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Tabela kluczowych gatunków

CAS #EC NumberHill FormulaMolar MassGrade Value
50-70-4200-061-5C₆H₁₄O₆182.17 g/molPh Eur,BP,NF,JP

Products

Numer katalogowyOpakowanie Ilość/opak.
1115979028 Pudlo tekturowe 25 kg
Description
Catalogue Number111597
SynonymsD-Glucitol
References
Product Information
CAS number50-70-4
EC number200-061-5
GradePh Eur,BP,NF,JP
Hill FormulaC₆H₁₄O₆
Molar Mass182.17 g/mol
HS Code2905 44 00
Structure formula ImageStructure formula Image
Quality LevelMQ500
Applications
Biological Information
Physicochemical Information
Density1.49 g/cm3 (20 °C)
Ignition temperature420 °C
Melting Point94 - 96 °C
pH value5.0 - 7 (182 g/l, H₂O, 25 °C)
Vapor pressure<0.1 hPa (25 °C)
Bulk density450 kg/m3
Solubility2350 g/l
Dimensions
Materials Information
Toxicological Information
LD 50 oralLD50 Szczur 15900 mg/kg
Safety Information according to GHS
RTECSLZ4290000
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
StoragePrzechowywać w +2°C do +25°C.
Packaging Information
Transport Information
Declaration (railroad and road) ADR, RIDKein Gefahrgut
Declaration (transport by air) IATA-DGRNo Dangerous Good
Declaration (transport by sea) IMDG-CodeNo Dangerous Good
Supplemental Information
Specifications
Assay (HPLC, calc.on anhydrous substance)97.0 - 100.5 %
Identitypasses test
pH-value (10 %; water)3.5 - 7.0
Appearance of solution (25 %; water)passes test
Spec. rotation (α20/D, 10 %, borate complex, calc. on anhydrous substance)+4.0 - +7.0 °
Conductivity (25°C) (20 %; water)≤ 20
Chloride (Cl)≤ 0.002 %
Sulfate (SO₄)≤ 0.006 %
Heavy metals (as Pb)≤ 5 ppm
As (Arsenic)≤ 1.0 ppm
Ni (Nickel) (#)≤ 1 ppm
Related substances (HPLC, Ph. Eur.) (major impurity)≤ 2.0 %
Related substances (HPLC, EP) (Sum of all impurities)≤ 3.0 %
Reducing sugars after hydrolysis/total sugar (as glucose)≤ 0.8
Reducing sugars (as glucose)≤ 0.11 %
Sulfated ash≤ 0.02 %
Loss on drying≤ 2.0 %
Water≤ 1.5 %
Residual solvents (ICH Q3C)excluded by manufacturing process
Microbiological testpasses test
Colony count (aerobic bacteria (TAMC))≤ 10²
Colony count (Yeasts and moulds (TYMC))≤ 10²
Salmonella spp.in 10g Substance not detectable
E.coliin 1g substance not detectable
Pseudomonas aeruginosain 1g substance not detectable
Staphylococcus aureusin 1g substance not detectable
Candida albicansIn 1g substance not detectable
Endotoxins≤ 1
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., BP, NF, JP
Global Trade Item Number
Numer katalogowy GTIN
1115979028 04022536936468

Documentation

Emprove Dossier

TitleVersion
9.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

Parteck® SI 400 LEX (sorbitol) MSDS

Title

Safety Data Sheet (SDS) 

Parteck® SI 400 LEX (sorbitol) Certificates of Analysis

Numer katalogowy OpakowanieSpecyfikacjaNumer partii
1115979028 Pudlo tekturoweDokument ze specyfikacją, w formacie PDF

Certificates

Title

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Kategorie

Small Molecule Pharmaceuticals > Formulation > Solid Dosage Form > Parteck Excipients > Parteck SI (Sorbitol)
Biopharmaceutical Manufacturing > Formulation > Liquid Dosage > Ingredients - Liquid
Small Molecule Pharmaceuticals > Formulation > Liquid Dosage Form > Ingredients - Liquid
Biopharmaceutical Manufacturing > Formulation > Liquid Dosage > Surfactants and Stabilizers
Small Molecule Pharmaceuticals > Formulation > Liquid Dosage Form > Surfactants and Stabilizers