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137010 di-Potasium hidrogen fosfat

anhidrat sesuai untuk produksi biofarmasi EMPROVE® EXPERT Ph Eur,BP,USP

di-Potasium hidrogen fosfat MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.

Synonyms: Dipotassium hydrogen phosphate, Potassium phosphate dibasic, Dipotassium Phosphate

CAS #: 7758-11-4 EC Number: 231-834-5 Molar Mass: 174.18 g/mol Chemical Formula: K₂HPO₄ Hill Formula: HK₂O₄P Grade: Ph Eur,BP,USP
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Overview

Replacement Information

Key Spec Table

CAS #EC NumberHill FormulaChemical FormulaMolar MassGrade Value
7758-11-4231-834-5HK₂O₄PK₂HPO₄174.18 g/molPh Eur,BP,USP
Description
Catalogue Number137010
SynonymsDipotassium hydrogen phosphate, Potassium phosphate dibasic, Dipotassium Phosphate
References
Product Information
CAS number7758-11-4
EC number231-834-5
GradePh Eur,BP,USP
Hill FormulaHK₂O₄P
Chemical formulaK₂HPO₄
Molar Mass174.18 g/mol
HS Code2835 24 00
Quality LevelMQ500
Applications
Biological Information
Physicochemical Information
Density2.45 g/cm3 (20.5 °C)
Melting Point450 °C (penguraian)
pH value9.2 (H₂O)
Bulk density700 - 1000 kg/m3
Solubility1600 g/l
Dimensions
Materials Information
Toxicological Information
LD 50 oralLD50 Tikus 8000 mg/kg
Safety Information according to GHS
RTECSTC5580000
Safety Information
Product Usage Statements
Storage and Shipping Information
Packaging Information
Transport Information
Supplemental Information
Specifications
Assay (alkalimetric, calculated on dried substance)98.0 - 100.5 %
Identitypasses test
Appearance of solutionpasses test
Insoluble substances≤ 0.2 %
pH-value (5 %; water)8.5 - 9.6
Carbonatepasses test
Chloride (Cl)≤ 0.02 %
Fluoride (F)≤ 0.001 %
Sulfate (SO₄)≤ 0.1 %
Al (Aluminium)≤ 0.0005 %
As (Arsenic)≤ 0.0002 %
Fe (Iron)≤ 0.0010 %
Na (Sodium)≤ 1.5 %
Na (sodium)passes test
Potassium dihydrogen phosphate≤ 2.5 %
Potassium dihydrogen phosphate and tri- Potassium phosphatepasses test
Residual solvents (ICH Q3C)excluded by manufacturing process
Reducing substancespasses test
Loss on drying (130 °C)≤ 1.0 %
Endotoxins≤ 2.5 I.U./g
Total aerobic microbial count≤ 100 CFU/g
Total yeast and mould count≤ 100 CFU/g
DNases (Exo- and endonucleases) (not detectable)passes test
RNases (not detectable)passes test
Proteases (not detectable)passes test
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,USP

Documentation

Material Qualification Dossier

TitleVersion
11.0

Quality Management Dossier (Open Access)

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Operational Excellence Dossier

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di-Potasium hidrogen fosfat MSDS

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Safety Data Sheet (SDS) 

di-Potasium hidrogen fosfat Certificates of Analysis

Product Number PackagingLot Number
137010

Certificates

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