Merck
All Photos(2)

1.06666

SAFC

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:
Molecular Weight:
294.10
Beilstein:
6104939
MDL number:
EC Index Number:
200-675-3

Agency

BP
JP
Ph. Eur.
USP

Quality Level

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)

biopharma process and formulation
liquid formulation
parenterals
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

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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

Storage Class Code

11 - Combustible Solids

WGK

WGK 1

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

What is the Emprove® Program?

The Emprove® Program is a system providing comprehensive and thorough documentation of our filters and single-use components, pharma raw materials, and starting materials.

Elemental Impurities Information

Available by subscription or for a fee

API Information Package

Available by subscription or for a fee

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Why are these documents unavailable?
Emprove® Dossiers contain information intended to support the registration process and risk assessment activities of pharmaceutical producers and contain confidential information. Please contact us if you would like access.

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