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141355 Alkohol poliwinylowy 18-88

odpowiedni do użytku jako substancja pomocnicza EMPROVE® ESSENTIAL Ph Eur,ChP,USP,JPE

Alkohol poliwinylowy 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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Replacement Information

Tabela kluczowych gatunków

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

Products

Numer katalogowyOpakowanie Ilość/opak.
1413551000 Butelka plastikowa 1 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 Szczur > 2000 mg/kg
Safety Information according to GHS
RTECSTR8100000
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 +15°C do +25°C.
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
Numer katalogowy GTIN
1413551000 04027269129880

Documentation

Emprove Dossier

TitleVersion
7.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

Alkohol poliwinylowy 18-88 MSDS

Title

Safety Data Sheet (SDS) 

Alkohol poliwinylowy 18-88 Certificates of Analysis

Numer katalogowy OpakowanieSpecyfikacjaNumer partii
1413551000 Butelka plastikowaDokument ze specyfikacją, w formacie PDF

Certificates

Title

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Small Molecule Pharmaceuticals > Formulation > Solid Dosage Form > Binders and Fillers
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Small Molecule Pharmaceuticals > Formulation > Liquid Dosage Form > Surfactants and Stabilizers