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817058 Maleic acid

Overview

Replacement Information

Key Spec Table

CAS #EC NumberHill FormulaChemical FormulaMolar MassGrade Value
110-16-7203-742-5C₄H₄O₄HOOCCH=CHCOOH116.07 g/molPh Eur,NF

Products

Catalogue NumberPackaging Qty/Pack
8170589025 Fibre carton 25 kg
Description
Catalogue Number817058
Synonymscis-Butenedioic acid
DescriptionMaleic acid suitable for use as excipient
References
Product Information
CAS number110-16-7
EC index number607-095-00-3
EC number203-742-5
GradePh Eur,NF
Hill FormulaC₄H₄O₄
Chemical formulaHOOCCH=CHCOOH
Molar Mass116.07 g/mol
HS Code2917 19 90
Structure formula ImageStructure formula Image
Quality LevelMQ500
Applications
Biological Information
Physicochemical Information
Density1.59 g/cm3 (20 °C)
Melting Point130 - 135 °C
pH value1.3 (100 g/l, H₂O, 20 °C)
Vapor pressure<0.1 hPa (20 °C)
Bulk density750 - 800 kg/m3
Solubility478.8 g/l
Dimensions
Materials Information
Toxicological Information
LD 50 oralLD50 Rat 708 mg/kg
LD 50 dermalLD50 Rabbit 1560 mg/kg
Safety Information according to GHS
Hazard Pictogram(s) Hazard Pictogram(s)
Hazard Pictogram(s)
Hazard Statement(s)H302 + H312: Harmful if swallowed or in contact with skin.
H314: Causes severe skin burns and eye damage.
H317: May cause an allergic skin reaction.
H335: May cause respiratory irritation.
Precautionary Statement(s)P260: Do not breathe dust.
P271: Use only outdoors or in a well-ventilated area.
P280: Wear protective gloves/ protective clothing/ eye protection/ face protection/ hearing protection.
P301 + P312: IF SWALLOWED: Call a POISON CENTER/doctor if you feel unwell.
P303 + P361 + P353: IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water.
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 WordDanger
RTECSOM9625000
Storage class8A Combustible, corrosive hazardous materials
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 dangerharmful, irritant, sensitizing
Product Usage Statements
Storage and Shipping Information
StorageStore at +15°C to +25°C.
Packaging Information
Transport Information
Declaration (railroad and road) ADR, RIDUN 3261 , 8, II
Declaration (transport by air) IATA-DGRUN 3261 , 8, II
Declaration (transport by sea) IMDG-CodeUN 3261 , 8, II, Segregation Group: 1 (Acids)
Supplemental Information
Specifications
Assay (calc.on anhydrous substance)99.0 - 101.0 %
Assay (HPLC, calc. on anhydrous substance)98.0 - 102.0 %
Identity (wet chemistry)passes test
Identity (HPLC)passes test
Identity (pH)passes test
Identity (TLC)passes test
Identity (IR)passes test
Appearance of solutionpasses test
Fe (Iron)≤ 5 ppm
V (Vanadium)*≤ 1 ppm
Fumaric acid (TLC)≤ 1.5 %
Fumaric acid (HPLC)≤ 1.0 %
Malic acid (HPLC)≤ 0.5 %
Residual solvents (ICH Q3C)excluded by the production process
Sulfated ash≤ 0.1 %
Water (K. F.)≤ 0.5 %
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, NF
Global Trade Item Number
Catalogue Number GTIN
8170589025 04022536648118

Documentation

Material Qualification Dossier

TitleVersion
8.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

Maleic acid SDS

Title

Safety Data Sheet (SDS) 

Maleic acid Certificates of Analysis

Product Number PackagingSpecificationLot Number
8170589025 Fibre cartonPDF Specification Document

Certificates

Title

Related Products & Applications

Categories

Small Molecule Pharmaceuticals > Formulation > Solid Dosage Form > pH Adjustment
Small Molecule Pharmaceuticals > Formulation > Semisolid Dosage Form > Acidulants and pH Adjustments
Reagents, Chemicals and Labware > Organic Synthesis > Organic Synthesis Product Groups > Carboxylic Acids > Di-and Polycarboxylic Acids
Biopharmaceutical Manufacturing > Formulation > Liquid Dosage > pH Adjustments and Isotonizers
Reagents, Chemicals and Labware > Organic Synthesis > Organic Synthesis Products for Pharma > Organic Synthesis Building Blocks and Reagents for Pharma > Carboxylic Acids > Di-and Polycarboxylic Acids
Small Molecule Pharmaceuticals > Formulation > Liquid Dosage Form > pH Adjustments and Isotonizers