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104091 Glycerol 85 %

EMPROVE® EXPERT Ph Eur,BP

Glycerol 85 % MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.

Synonyms: Glycerin, 1,2,3-Propanetriol, Trihydroxylpropane, Protol

Grade: Ph Eur,BP
104091
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Přehled

Replacement Information

Tabulka spec. kláve

Grade Value
Ph Eur,BP

Products

Katalogové čísloBalení ks/bal.
1040911000 Plastová láhev 1 l
Description
Catalogue Number104091
SynonymsGlycerin, 1,2,3-Propanetriol, Trihydroxylpropane, Protol
References
Product Information
GradePh Eur,BP
HS Code2905 45 00
Structure formula ImageStructure formula Image
Quality LevelMQ500
Applications
Biological Information
Physicochemical Information
Boiling point>130 °C (1013 hPa)
Density1.23 g/cm3 (20 °C)
Flash point199 °C
Ignition temperature429 °C
Melting Point-10 °C
pH value5 (100 g/l, H₂O, 20 °C)
Vapor pressure8 hPa (20 °C)
Dimensions
Materials Information
Toxicological Information
Safety Information according to GHS
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 +30°C.
Packaging Information
Transport Information
Supplemental Information
Specifications
Assay (alkalimetric after oxidation)83.5 - 88.5 %
Identitypasses test
Appearance of solutionpasses test
Acidity or alkalinitypasses test
Refractive index (n 20/D)1.449 - 1.455
Density (d 20/4)1.221 - 1.232 g/cm³
Chloride (Cl)≤ 0.0010 %
Halogenated compounds (as Cl)≤ 0.0030 %
Heavy metals (as Pb)≤ 0.0005 %
Aldehydes≤ 10 ppm
Acetone≤ 0.5 %
Other residual solvents (ICH Q3C)...excluded by production process
Diethylene glycol and related Substances (impurity A)≤ 0.1 %
Diethylene glycol and related Substances (any further impurity)≤ 0.1 %
Diethylene glycol and related Substances (Sum of all impurities)≤ 0.5 %
Esterspasses test
Sugarpasses test
Sulfated ash≤ 0.01 %
Water12.0 - 16.0 %
Endotoxins≤ 2.5 I.U./ml
Microbiological purity (Total aerobic microbial count (TAMC))≤ 1E+02 CFU/ml
Microbiological purity (Total yeast and mould count (TYMC))≤ 1E+01 CFU/ml

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
Global Trade Item Number
Katalogové číslo GTIN
1040911000 04022536047416

Documentation

Material Qualification Dossier

TitleVersion
5.1

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

Glycerol 85 % MSDS

Title

Safety Data Sheet (SDS) 

Certificates

Title

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Accessories (Primary)

Katalogové číslo Popis
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Accessories (Secondary)

Katalogové číslo Popis
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109204 Giemsova azur-eosin-methylenová modř roztok
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Coatings
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Kategorie

Small Molecule Pharmaceuticals > Formulation > Semisolid Dosage Form > Acidulants and pH Adjustments
Biopharmaceutical Manufacturing > Formulation > Liquid Dosage > Thickeners
Biopharmaceutical Manufacturing > Formulation > Liquid Dosage > Solvents
Small Molecule Pharmaceuticals > Formulation > Semisolid Dosage Form > Thickeners
Small Molecule Pharmaceuticals > Formulation > Liquid Dosage Form > Solvents
Small Molecule Pharmaceuticals > Formulation > Liquid Dosage Form > Thickeners
Biopharmaceutical Manufacturing > Formulation > Liquid Dosage > Tonicity Agents
Small Molecule Pharmaceuticals > Formulation > Liquid Dosage Form > Tonicity Agents