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111597 Parteck® SI 400 LEX (Sorbitol)

Přehled

Replacement Information

Tabulka spec. kláve

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

Products

Katalogové čísloBalení ks/bal.
1115972500 Plastová láhev 2.5 kg
1115979012 Plastový sud 12 kg
1115979024 Plastový sud 25 kg
1115979028 Lepenková bedna 25 kg
1115979050 50 kg
1115979500 Big Bag 500 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 Potkan 15900 mg/kg
Safety Information according to GHS
RTECSLZ4290000
Storage class10 - 13 Ostatní kapalné a tuhé látky
WGKWGK 1 látka mírně ohrožující vody
Disposal3
Relativně nereaktivní organické reagencie mohou být shromažďovány v kontejneru A. Pokud jsou halogenované, musí být umístěny v kontejneru B. U pevných reziduí použijte kontejner C.
Safety Information
Product Usage Statements
Storage and Shipping Information
StorageSkladovat od +2°C až +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
Katalogové číslo GTIN
1115972500 04027269130848
1115979012 04027269138134
1115979024 04027269170844
1115979028 04022536936468
1115979050 04022536133720
1115979500 04022536907703

Documentation

Material Qualification 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

Katalogové číslo BaleníSpecifikaceČíslo šarže
1115972500 Plastová láhevSpecifikující dokument ve formátu PDF
1115979012 Plastový sudSpecifikující dokument ve formátu PDF
1115979024 Plastový sudSpecifikující dokument ve formátu PDF
1115979028 Lepenková bednaSpecifikující dokument ve formátu PDF
1115979050 Specifikující dokument ve formátu PDF
1115979500 Big BagSpecifikující dokument ve formátu PDF

Certificates

Title

Související produkty a aplikace

Související produkty: Brand Facete

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