Merck
All Photos(3)

1.06235

SAFC

Sodium acetate trihydrate

EMPROVE® API Ph Eur,BP,JP,USP,FCC,E 262

Synonym(s):
Acetic acid sodium salt trihydrate
Linear Formula:
CH3COONa · 3H2O
CAS Number:
Molecular Weight:
136.08
Beilstein:
3732037
MDL number:
E Number:
E262
EC Index Number:
204-823-8

Quality Level

Agency

BP
JP
Ph. Eur.
USP

reg. compliance

FCC

product line

EMPROVE® API

form

solid

autoignition temp.

1112 °F
607 °C

potency

3530 mg/kg LD50, oral (Rat)
>10000 mg/kg LD50, skin (Rabbit)

pH

7.5-9.2 (20 °C, 50 g/L in H2O)

mp

58 °C

transition temp

flash point >250 °C (anhydrous substance)

density

1.42 g/cm3 at 20 °C

bulk density

900 kg/m3

application(s)

liquid formulation
parenterals
pharmaceutical
semi-solid formulation
solid formulation

storage temp.

2-25°C

SMILES string

O.O.O.[Na+].CC([O-])=O

InChI

1S/C2H4O2.Na.3H2O/c1-2(3)4;;;;/h1H3,(H,3,4);;3*1H2/q;+1;;;/p-1

InChI key

AYRVGWHSXIMRAB-UHFFFAOYSA-M

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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

Sodium acetate trihydrate is used in the dialysis, insulin and infution solutions. Sodium acetate trihydrate Emprove® API is manufactured according to ICH Q7 guidelines. A CEP and US-DMF are avaiable.

Other Notes

Enzyme substrate for acetate kinase (EC 2.7.2.1)

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

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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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