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137030 Mocznik

kryst., odpowiedni do produkcji biofarmaceutycznej EMPROVE® EXPERT Ph Eur,BP,ChP,JP,USP,ACS

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

Synonyms: Carbamide, Carbonyl diamide, Diaminomethanone, Carbonyldiamine

CAS #: 57-13-6 EC Number: 200-315-5 Molar Mass: 60.05 g/mol Chemical Formula: CO(NH₂)₂ Hill Formula: CH₄N₂O Grade: Ph Eur,BP,ChP,JP,USP,ACS
137030
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Tabela kluczowych gatunków

CAS #EC NumberHill FormulaChemical FormulaMolar MassGrade Value
57-13-6200-315-5CH₄N₂OCO(NH₂)₂60.05 g/molPh Eur,BP,ChP,JP,USP,ACS

Products

Numer katalogowyOpakowanie Ilość/opak.
1370305000 Butelka plastikowa 5 kg
Description
Catalogue Number137030
SynonymsCarbamide, Carbonyl diamide, Diaminomethanone, Carbonyldiamine
References
Product Information
CAS number57-13-6
EC number200-315-5
GradePh Eur,BP,ChP,JP,USP,ACS
Hill FormulaCH₄N₂O
Chemical formulaCO(NH₂)₂
Molar Mass60.05 g/mol
HS Code3105 10 00
Structure formula ImageStructure formula Image
Quality LevelMQ500
Applications
Biological Information
Physicochemical Information
Density1.32 g/cm3 (20 °C)
Melting Point134 °C
pH value7.5 - 9.5 (480 g/l, H₂O, 25 °C)
Vapor pressure<0.1 hPa (25 °C)
Bulk density720 - 760 kg/m3
Solubility1000 g/l
Dimensions
Materials Information
Toxicological Information
LD 50 oralLD50 Szczur 8471 mg/kg
LD 50 dermalLD50 Szczur 8200 mg/kg
Safety Information according to GHS
RTECSYR6250000
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 +2°C do +30°C.
Packaging Information
Transport Information
Supplemental Information
Specifications
Assay (HPLC)98.0 - 102.0 %
Assay (HPLC, calc.on dried substance)98.0 - 102.0 %
Assay (ex N)99.0 - 100.5 %
Assay (ex N, calc. on dried substance)99.0 - 101.0 %
Assay (ACS)99.0 - 100.5 %
Identity (wet chemistry)conforms
Identity (Melting point)conforms
Identity (IR)conforms
Identity (HPLC)conforms
Identity (HPLC) (ChP)conforms
Appearance of solution (5 %; water)conforms
Clarity and color of solution (ChP)conforms
In ethanol (96 %) insoluble parts≤ 0.04 %
In water insoluble matter≤ 0.01 %
Alkalinityconforms
Melting point (DSC (differential scanning calorimetry))132.5 - 134.5 °C
Chloride (Cl) (ACS)≤ 0.0005 %
Chloride (Cl)≤ 0.007 %
Sulfate (SO₄)≤ 0.001 %
Sulfate (SO₄) (ChP/JP)≤ 0.010 %
Heavy metals (as Pb)≤ 0.0010 %
Heavy metals (ACS)≤ 0.001 %
Fe (Iron)≤ 0.001 %
NH₄ (Ammonium)≤ 0.0500 %
Biuret≤ 0.1 %
Organic Impurities (Related compound A)≤ 0.1 %
Organic Impurities (Any individual unspecified impurity)≤ 0.1 %
Organic Impurities (Total impurities)≤ 2.0 %
Related substances (HPLC) (Biuret) (ChP)≤ 0.1 %
Related substances (HPLC) (Triuret) (ChP)≤ 0.1 %
Related substances (HPLC) (Any individual unspecified impurity) (ChP)≤ 0.2 %
Related substances (HPLC) (Total impurities) (ChP)≤ 2.0 %
Residual solvents (ICH Q3C)excluded by the manufacturing process
Sulfated ash (600 °C)≤ 0.01 %
Loss on Drying (105 °C)≤ 1.0 %
Endotoxins≤ 3.00 I.U./g
Microbiological purity (Total aerobic microbial count (TAMC))≤ 1E+02 CFU/g
Microbiological purity (Total yeast and mould count (TYMC))≤ 1E+02 CFU/g
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, ChP, JP, USP, ACS
Global Trade Item Number
Numer katalogowy GTIN
1370305000 04027269078324

Documentation

Emprove Dossier

TitleVersion
9.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

Mocznik MSDS

Title

Safety Data Sheet (SDS) 

Mocznik Certificates of Analysis

Numer katalogowy OpakowanieSpecyfikacjaNumer partii
1370305000 Butelka plastikowaDokument ze specyfikacją, w formacie PDF

Certificates

Title