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141355 Polivinilalkohol, 18-88

gyógyszerkészítési segédanyag minőség EMPROVE® ESSENTIAL Ph Eur,ChP,USP,JPE

Polivinilalkohol, 18-88 MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.

Synonyms: PVA, PVOH

CAS #: 9002-89-5 Grade: Ph Eur,ChP,USP,JPE
141355
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Áttekintés

Replacement Information

Kulcsspecifikációk táblázata

CAS #Grade Value
9002-89-5Ph Eur,ChP,USP,JPE

Products

KatalógusszámCsomagolás Menny./csomag
1413551000 Muanyagpalack 1 kg
1413559029 Dupla PE zsák 25 kg
Description
Catalogue Number141355
SynonymsPVA, PVOH
References
Product Information
CAS number9002-89-5
GradePh Eur,ChP,USP,JPE
HS Code3905 30 00
Quality LevelMQ500
Applications
Biological Information
Physicochemical Information
Melting Point160 - 240 °C
Bulk density400 - 670 kg/m3
Dimensions
Materials Information
Toxicological Information
LD 50 oralLD50 Patkány > 2000 mg/kg
Safety Information according to GHS
RTECSTR8100000
Storage class10 - 13 Egyéb folyadékok és szilárd anyagok
WGKWGK 1 enyhén vízszennyező
Disposal3
Relatively unreactive organic reagents should be collected in container A. If halogenated, they should be collected in container B. For solid residues use container C.
Safety Information
Product Usage Statements
Storage and Shipping Information
Storage+15°C és +25°C között tárolandó.
Packaging Information
Transport Information
Supplemental Information
Specifications
Identity (IR spectrum)passes test
Identity (Viscosity)passes test
Identity (Reaction with iodine)passes test
Identity (Reaction with iodine and boric acid)passes test
Identity (Reaction with ethanol)passes test
Appearance of solution (40 g/l, water)passes test
Appearance of solution (50 g/l, water)passes test
Water-insoluble matter (40 g/l, water)≤ 0.1 %
pH-Value (40 g/l; water)5.0 - 6.5
Viscosity (40 g/l; water)15.3 - 20.7 mPa∙s
As (Arsenic)≤ 2 ppm
As (Arsenic) (ChP)≤ 2 ppm
Heavy metals (as Pb)≤ 10 ppm
Heavy metals (as Pb) (ChP)≤ 10 ppm
Crotonaldehyde (GC)≤ 10 ppm
Acetic acid (alkalimetric)≤ 0.5 %
Methanol (GC)≤ 1.0 %
Methanol (GC) (JPE)¹≤ 1.0 %
Methyl acetate (GC)≤ 1.0 %
Other residual solvents (ICH Q3C)excluded by production process
Ester value130 - 150
Degree of hydrolysis (USP)85 - 89 %
Degree of hydrolysis (JPE)78 - 96 %
Acid value≤ 3.0
Saponification value132 - 152
Residue on ignition≤ 1.0 %
Sulfated ash≤ 1.0 %
Loss on Drying (105 °C)≤ 5.0 %
Microbiological purity (Total aerobic microbial count (TAMC))≤ 100 CFU/g
Microbiological purity (Total yeast and mould count (TYMC))≤ 100 CFU/g
Bile-tolerant gram-negative bacteria (absent in 1 g)conforms
Escherichia coli (absent in 1 g)conforms
Pseudomonas aeruginosa (absent in 1 g)conforms
Staphylococcus aureus (absent in 1 g)conforms
Candida albicans (absent in 1 g)conforms
Salmonella (absent in 10 g)conforms
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 (*).
¹ Value measured in qualified external laboratory
Corresponds to Ph Eur,ChP,USP,JPE
Global Trade Item Number
Katalógusszám GTIN
1413551000 04027269129880
1413559029 04027269129910

Documentation

Material Qualification Dossier

TitleVersion
7.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

Polivinilalkohol, 18-88 MSDS

Title

Safety Data Sheet (SDS) 

Polivinilalkohol, 18-88 Certificates of Analysis

Cikkszám CsomagolásSpecifikációSarzsszám
1413551000 MuanyagpalackSpecifikációk, PDF dokumentum
1413559029 Dupla PE zsákSpecifikációk, PDF dokumentum

Certificates

Title

Kapcsolódó termékek és alkalmazások

Kategóriák

Biopharmaceutical Manufacturing > Formulation > Liquid Dosage > Thickeners
Small Molecule Pharmaceuticals > Formulation > Semisolid Dosage Form > Surfactants and Stabilizers
Biopharmaceutical Manufacturing > Formulation > Liquid Dosage > Surfactants and Stabilizers
Small Molecule Pharmaceuticals > Formulation > Semisolid Dosage Form > Thickeners
Small Molecule Pharmaceuticals > Formulation > Liquid Dosage Form > Thickeners
Small Molecule Pharmaceuticals > Formulation > Solid Dosage Form > Binders and Fillers
Small Molecule Pharmaceuticals > Formulation > Solid Dosage Form > Coatings
Small Molecule Pharmaceuticals > Formulation > Liquid Dosage Form > Surfactants and Stabilizers