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137003 Citric acid monohydrate

cryst. EMPROVE® EXPERT Ph Eur,BP,ChP,JP,USP

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

Synonyms: 2-Hydroxypropane-1,2,3-tricarboxylic acid, Hydroxytricarballylic acid

CAS #: 5949-29-1 EC Number: 201-069-1 Molar Mass: 210.14 g/mol Hill Formula: C₆H₈O₇ * H₂O Grade: Ph Eur,BP,ChP,JP,USP
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137003
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Overview

Replacement Information

Key Spec Table

CAS #EC NumberHill FormulaMolar MassGrade Value
5949-29-1201-069-1C₆H₈O₇ * H₂O210.14 g/molPh Eur,BP,ChP,JP,USP

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          1.37003.9012
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              1.37003.9029
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                  		 Double PE Sack 25 kg
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                  Description
                  Catalogue Number137003
                  Synonyms2-Hydroxypropane-1,2,3-tricarboxylic acid, Hydroxytricarballylic acid
                  References
                  Product Information
                  CAS number5949-29-1
                  EC number201-069-1
                  GradePh Eur,BP,ChP,JP,USP
                  Hill FormulaC₆H₈O₇ * H₂O
                  Molar Mass210.14 g/mol
                  HS Code2918 14 00
                  Structure formula ImageStructure formula Image
                  Quality LevelMQ500
                  Applications
                  Biological Information
                  Physicochemical Information
                  Density1.54 g/cm3 (20 °C)
                  Flash point173.9 °C Not applicable
                  Melting Point135 - 152 °C
                  pH value1.8 (50 g/l, H₂O, 20 °C)
                  Vapor pressure<1 Pa (25 °C)
                  Bulk density800 - 1000 kg/m3
                  Solubility880 g/l
                  Dimensions
                  Materials Information
                  Toxicological Information
                  LD 50 oralLD50 Rat 3000 mg/kg
                  Safety Information according to GHS
                  Hazard Pictogram(s) Hazard Pictogram(s)
                  Hazard Statement(s)H319: Causes serious eye irritation.
                  H335: May cause respiratory irritation.
                  Precautionary Statement(s)P261: Avoid breathing dust.
                  P264: Wash skin thoroughly after handling.
                  P271: Use only outdoors or in a well-ventilated area.
                  P280: Wear eye protection/ face protection.
                  P304 + P340 + P312: IF INHALED: Remove person to fresh air and keep comfortable for breathing. Call a POISON CENTER/doctor if you feel unwell.
                  P305 + P351 + P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
                  Signal WordWarning
                  RTECSGE7810000
                  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
                  Categories of dangerirritant
                  Product Usage Statements
                  Storage and Shipping Information
                  StorageStore at +15°C to +25°C.
                  Packaging Information
                  Transport Information
                  Declaration (railroad and road) ADR, RIDKein Gefahrgut
                  Declaration (transport by air) IATA-DGRNo Dangerous Good
                  Declaration (transport by sea) IMDG-CodeNo Dangerous Good
                  Supplemental Information
                  Specifications
                  Assay (alkalimetric, calculated on anhydrous substance)99.5 - 100.5 %
                  Identity (IR-spectrum)passes test
                  Identity (wet chemistry)passes test
                  Appearancewhite to almost white or colorless crystals
                  Appearance of solution (200 g/l; water)clear (≤ 1.5 NTU) and not more intense in color than reference solution Y₇, BY₇ or GY₇
                  Chloride (Cl)≤ 5 ppm
                  Sulfate (SO₄)≤ 50 ppm
                  Heavy metals (as Pb)≤ 5 ppm
                  Al (Aluminium)≤ 0.2 ppm
                  As (Arsenic)≤ 1 ppm
                  Ca (Calcium)passes test
                  Fe (Iron)≤ 10 ppm
                  Oxalates (as C₂H₂O₄)≤ 360 ppm
                  Oxalate (C₂H₂O₄) (ChP)passes test
                  Residual solvents (ICH (Q3C))excluded by manufacturing process
                  Readily carbonisable substancepasses test
                  Sulfated ash (600 °C)≤ 0.05 %
                  Water (according to Karl Fischer)7.5 - 9.0 %
                  Total aerobic microbial count (TAMC)≤ 100 CFU/g
                  Total combined yeasts/moulds count (TYMC)≤ 10 CFU/g
                  Bile-tolerant gram-negative bacteria (absent in 1 g)passes test
                  Candida albicans (absent in 1 g)passes test
                  Escherichia coli (absent in 1 g)passes test
                  Pseudomonas aeruginosa (absent in 1 g)passes test
                  Salmonella (absent in 10 g)passes test
                  Staphylococcus aureus (absent in 1 g)passes test
                  DNases (Exo- and endonucleases)not detectable
                  RNasesnot detectable
                  Bacterial endotoxins< 10

                  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
                  Global Trade Item Number
                  Catalogue Number GTIN
                  1.37003.1000 04027269364946
                  1.37003.5000 04027269061432
                  1.37003.9012 04027269077426
                  1.37003.9029 04027269061968

                  Documentation

                  Material Qualification Dossier

                  TitleVersion
                  9.0

                  Quality Management Dossier (Open Access)

                  Title

                  Operational Excellence Dossier

                  Title

                  Citric acid monohydrate SDS

                  Title

                  Safety Data Sheet (SDS) 

                  Citric acid monohydrate Certificates of Analysis

                  Product Number PackagingSpecificationLot Number
                  1.37003.1000 Plastic bottlePDF Specification Document
                  1.37003.5000 Plastic bottlePDF Specification Document
                  1.37003.9012 Bucket, plasticPDF Specification Document
                  1.37003.9029 Double PE SackPDF Specification Document

                  Certificates

                  Title

                  Brochure

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