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137030 Urea

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

Pricing & Availability

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1.37030.5000
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      Plastic bottle 5 kg
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      1.37030.9012
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          Bucket, plastic 12 kg
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          1.37030.9029
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              Double PE Sack 25 kg
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              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
              1.37030.5000 04027269078324
              1.37030.9012 04027269078331
              1.37030.9029 04027269078348

              Documentation

              Material Qualification Dossier

              TitleVersion
              9.0

              Quality Management Dossier (Open Access)

              Title

              Operational Excellence Dossier

              Title

              Urea SDS

              Title

              Safety Data Sheet (SDS) 

              Urea Certificates of Analysis

              Product Number PackagingSpecificationLot Number
              1.37030.5000 Plastic bottlePDF Specification Document
              1.37030.9012 Bucket, plasticPDF Specification Document
              1.37030.9029 Double PE SackPDF Specification Document

              Certificates

              Title

              Brochure

              Title
              バイオ医薬品製造用製品ガイド