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Key Documents

Safety Information

1.02160

SAFC

Calcium sulfate dihydrate

precipitated, EMPROVE® ESSENTIAL, Ph. Eur., BP, E 516

Pharma Manufacturing

Synonym(s):

Calcium sulfate dihydrate

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About This Item

Empirical Formula (Hill Notation):
CaO4S · 2H2O
CAS Number:
Molecular Weight:
172.17
MDL number:
UNSPSC Code:
12352302
E Number:
E516
EC Index Number:
231-900-3

Agency

BP
Ph. Eur.

Quality Level

product line

EMPROVE® ESSENTIAL

form

solid

potency

>10000 mg/kg LD50, oral (Rat)

pH

7.0 (20 °C, 50 g/L in H2O, slurry)

solubility

2 g/L

density

2.32 g/cm3 at 20 °C

application(s)

pharmaceutical
solid formulation

storage temp.

2-30°C

InChI

1S/Ca.H2O4S.2H2O/c;1-5(2,3)4;;/h;(H2,1,2,3,4);2*1H2/q+2;;;/p-2

InChI key

PASHVRUKOFIRIK-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

Calcium sulfate dihydrate is typically used in solid oral formulations such as tablets or capsules as well as in the beverage industry.

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 Listings

Regulatory Listings are mainly provided for chemical products. Only limited information can be provided here for non-chemical products. No entry means none of the components are listed. It is the user’s obligation to ensure the safe and legal use of the product.

ISHL Indicated Name

Substances Subject to be Indicated Names

ISHL Notified Names

Substances Subject to be Notified Names

JAN Code

1021609999:
1021600000:
1021600500:
CO1E1021601000:
1021609051:
1021609050:
1021601000:
CO1E1021609050:
1021609029:
1021600001:
1021609025:
1021609028:
1021601001:


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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