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Key Documents

1.06386

SAFC

Sodium carbonate monohydrate

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

Pharma Manufacturing

Synonym(s):

Sodium carbonate monohydrate, Soda monohydrate, Sodium Carbonate Monohydrate

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About This Item

Empirical Formula (Hill Notation):
CNa2O3 · xH2O
CAS Number:
Molecular Weight:
105.99 (anhydrous basis)
MDL number:
UNSPSC Code:
12352302
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.

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

signalword

Warning

hcodes

Hazard Classifications

Eye Irrit. 2

Storage Class

13 - Non Combustible Solids

wgk_germany

WGK 1

flash_point_f

Not applicable

flash_point_c

Not applicable


Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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