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Safety Information

1.06666

SAFC

tri-Sodium citrate dihydrate low in endotoxins,

EMPROVE® API Ph Eur,BP,JP,USP

Pharma Manufacturing

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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
UNSPSC Code:
12352302
EC Index Number:
200-675-3

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

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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

Regulatory Information

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Strategies for the Development of Safe and Effective Pediatric Formulations

Medicine for children poses unique formulation challenges compared to adults. Consider developmental physiology and age specifics when designing pharmaceuticals. Quality issues can severely impact patient safety. Therefore, excipient quality, supplier selection, and supply chain security are crucial, particularly for pediatric formulations.

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Pediatric Formulations

Developing formulations specifically for infants and children is increasingly important. To help you master these challenges effectively, we offer an extensive portfolio of well-established high-quality excipients and APIs for pediatric pharmaceutical formulations that are proven in practice.

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