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111597 ParTeck® SI 400 LEX (Sorbitol)

Overview

Replacement Information

Key Spec Table

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

Products

Catalogue NumberPackaging Qty/Pack
1115972500 Plastová flaša 2.5 kg
1115979012 Plastový sud 12 kg
1115979024 Plastový sud 25 kg
1115979028 Kartónová krabica 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 Iné kvapaliny a tuhé látky
WGKWGK 1 mierne ohrozujúce vody
Disposal3
Relatívne nereaktívne organické reagencie je potrebné zhromaždovať v nádobe A. Ak sú halogénované, je potrebné ich zhromaždovať v nádobe B. Pre tuhé zvyšky použite nádobu C.
Safety Information
Product Usage Statements
Storage and Shipping Information
StorageSkladujte pri +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
Catalogue Number 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

Product Number PackagingSpecificationLot Number
1115972500 Plastová flašaPDF Specification Document
1115979012 Plastový sudPDF Specification Document
1115979024 Plastový sudPDF Specification Document
1115979028 Kartónová krabicaPDF Specification Document
1115979050 PDF Specification Document
1115979500 Big BagPDF Specification Document

Certificates

Title

Related Products & Applications

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Categories

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