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137030 尿素

cryst. suitable for the biopharmaceutical production EMPROVE® EXPERT Ph Eur,BP,ChP,JP,USP,ACS

尿素 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
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137030
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Overview

Replacement Information

Key Spec Table

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

Products

Catalogue NumberPackaging Qty/Pack
1.37030.1000 塑膠瓶 1 kg
1.37030.5000 塑膠瓶 5 kg
1.37030.9012 塑膠桶 12 kg
1.37030.9026 塑膠滾桶 25 kg
1.37030.9029 雙層PE袋 25 kg
1.37030.9526 雙層PE袋 21 x 25 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 Rat 8471 mg/kg
LD 50 dermalLD50 Rat 8200 mg/kg
Safety Information according to GHS
RTECSYR6250000
Storage class10 - 13 Other liquids and solids
WGKWGK 1 slightly hazardous to water
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
StorageStore at +2°C to +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
Catalogue Number GTIN
1.37030.1000 04061841010357
1.37030.5000 04027269078324
1.37030.9012 04027269078331
1.37030.9026 04027269293284
1.37030.9029 04027269078348
1.37030.9526 04027269966638

Documentation

Material Qualification Dossier

TitleVersion
9.0

Quality Management Dossier (Open Access)

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Operational Excellence Dossier

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尿素 MSDS

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Safety Data Sheet (SDS) 

尿素 Certificates of Analysis

Product Number PackagingSpecificationLot Number
1.37030.1000 塑膠瓶PDF Specification Document
1.37030.5000 塑膠瓶PDF Specification Document
1.37030.9012 塑膠桶PDF Specification Document
1.37030.9026 塑膠滾桶PDF Specification Document
1.37030.9029 雙層PE袋PDF Specification Document
1.37030.9526 雙層PE袋PDF Specification Document

Certificates

Title