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100243 檸檬酸

powder, suitable for use as excipient EMPROVE® ESSENTIAL Ph Eur,BP,ChP,JP,USP,E 330,FCC

檸檬酸 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,E 330,FCC
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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,E 330,FCC

Products

Catalogue NumberPackaging Qty/Pack
1.00243.1000 塑膠瓶 1 kg
1.00243.9025 纖維紙箱 25 kg
1.00243.9026 塑膠滾桶 25 kg
1.00243.9029 雙層PE袋 25 kg
Description
Catalogue Number100243
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,E 330,FCC
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 不適用
Melting Point135 - 152 °C
pH value1.85 (50 g/l, H₂O, 25 °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 +2°C to +30°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, fine powder
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
Hg (Mercury)≤ 1 ppm
Pb (Lead)≤ 0.5 ppm
Oxalates (as C₂H₂O₄)≤ 100 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 - 8.8 %
Particle size (> 0.3 mm)≤ 5.0 %
Bacterial endotoxins< 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., BP, ChP, JP, USP, E 330, FCC
Conforms to the purity criteria on food additives according to the current European Commission Regulation.
Global Trade Item Number
Catalogue Number GTIN
1.00243.1000 04022536003351
1.00243.9025 04022536003375
1.00243.9026 04027269164522
1.00243.9029 04022536939759

Documentation

Material Qualification Dossier

TitleVersion
10.1

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

檸檬酸 MSDS

Title

Safety Data Sheet (SDS) 

檸檬酸 Certificates of Analysis

Product Number PackagingSpecificationLot Number
1.00243.1000 塑膠瓶PDF Specification Document
1.00243.9025 纖維紙箱PDF Specification Document
1.00243.9026 塑膠滾桶PDF Specification Document
1.00243.9029 雙層PE袋PDF Specification Document

Certificates

Title

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Categories

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Biopharmaceutical Manufacturing > Formulation > Liquid Dosage > pH Adjustments and Isotonizers
Small Molecule Pharmaceuticals > Formulation > Liquid Dosage Form > Taste Modifiers
Small Molecule Pharmaceuticals > Formulation > Liquid Dosage Form > pH Adjustments and Isotonizers
Biopharmaceutical Manufacturing > Formulation > Liquid Dosage > Taste Modifiers
Small Molecule Pharmaceuticals > Formulation > Solid Dosage Form > Taste Modifiers