MilliporeSigma
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1.06386

SAFC

Sodium carbonate monohydrate

EMPROVE® ESSENTIAL, Ph. Eur., BP, NF, E 500

Synonym(s):
Sodium carbonate monohydrate, Soda monohydrate, Sodium Carbonate Monohydrate
Empirical Formula (Hill Notation):
CNa2O3 · xH2O
CAS Number:
Molecular Weight:
105.99 (anhydrous basis)
MDL number:
E Number:
E500
EC Index Number:
207-838-8

Agency

BP
NF
Ph. Eur.

Quality Level

product line

EMPROVE® ESSENTIAL

form

solid

pH

11-12 (25 °C, 50 g/L in H2O)

mp

854 °C (anhydrous substance)

density

2.25 g/cm3 at 20 °C

application(s)

liquid formulation
pharmaceutical
solid formulation

storage temp.

2-30°C

InChI

1S/CH2O3.2Na.H2O/c2-1(3)4;;;/h(H2,2,3,4);;;1H2/q;2*+1;/p-2

InChI key

MQRJBSHKWOFOGF-UHFFFAOYSA-L

General description

Finding the right excipient that matches your needs as well as regulatory demands can be a complicated challenge in formulation. With our application know-how and regulatory expertise, we support you in every step of development, scale-up, and production.
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 carbonate is a commonly used ingredient in both food and pharmaceutics. In pharmaceutical applications, sodium carbonate is used as pH adjuster, or a source of carbon dioxide in oral formulations such as effervescent tablets or granules.

Packaging

1, 3×1 kg in PE bottle
25 kg in double PE bag (DPES in carton)

Legal Information

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

Pictograms

Exclamation mark

Signal Word

Warning

Hazard Statements

Hazard Classifications

Eye Irrit. 2

Storage Class Code

13 - Non 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.

Material Qualification Dossier

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Quality Management Dossier

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Operational Excellence Dossier

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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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