1.06666

tri-Sodium citrate dihydrate low in endotoxins,

EMPROVE^® API Ph Eur,BP,JP,USP

• Synonym(s): Sodium citrate tribasic dihydrate, Trisodium Citrate, Sodium Citrate, Dihydrate, Citric acid trisodium salt dihydrate, Trisodium citrate dihydrate
• Linear Formula: HOC(COONa)(CH₂COONa)₂ · 2H₂O
• CAS Number: 6132-04-3
• Molecular Weight: 294.10
• Beilstein: 6104939
• MDL number: MFCD00150031
• EC Index Number: 200-675-3

Properties

• Agency: BP; JP; Ph. Eur.; USP
• Quality Level: 600
• product line: EMPROVE^® API
• form: solid
• potency: >8000 mg/kg LD₅₀, oral (Rat)
• pH: 7.5-9.0 (25 °C, 50 g/L in H₂O)
• mp: 150 °C (anhydrous substance); >300 °C (lit.)
• solubility: 720 g/L
• bulk density: 600 kg/m³
• application(s): liquid formulation; parenterals; pharma/biopharma processes; pharmaceutical; solid formulation
• storage temp.: 2-25°C
• SMILES string: O.O.[Na+].[Na+].[Na+].OC(CC([O-])=O)(CC([O-])=O)C([O-])=O
• InChI: 1S/C6H8O7.3Na.2H2O/c7-3(8)1-6(13,5(11)12)2-4(9)10;;;;;/h13H,1-2H2,(H,7,8)(H,9,10)(H,11,12);;;;2*1H2/q;3*+1;;/p-3
• InChI key: NLJMYIDDQXHKNR-UHFFFAOYSA-K

Description

General description

We provide industry-leading production know-how and comprehensive regulatory support for high-quality APIs, backed by nearly 200 years of experience. From a complete portfolio of innovative folates to custom synthesis, our customized and scalable solutions meet your specific production needs. As part of our Emprove^® Program, our raw materials are offered with extensive documentation facilitating compliance of your pharma and biopharma product, full supply chain transparency and risk mitigation. Our SAFC^® portfolio of high-quality products for biopharmaceutical and pharmaceutical formulation and production withstands strict quality control procedures and is produced according to applicable cGMP guidelines.

Application

tri-Sodium citrate dihydrate is used as anticoagulant in dialysis and plasmapheresis. tri-Sodium citrate dihydrate Emprove^® API is manufactured according to ICH Q7 guidelines. An ASMF and US-DMF is available.

Legal Information

Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany

SAFC is a registered trademark of Merck KGaA, Darmstadt, Germany

Safety Information

• Storage Class Code: 11 - Combustible Solids
• WGK: WGK 1
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable