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Safety Information

1.02465

SAFC

Calcium chloride dihydrate

EMPROVE® API, Ph. Eur., BP, ChP, JP, USP

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Synonym(s):
Calcium dichloride
Empirical Formula (Hill Notation):
CaCl2 · 2H2O
CAS Number:
10035-04-8
Molecular Weight:
147.01
MDL number:
MFCD00149613
EC Index Number:
600-075-5

Agency

BP
ChP
JP
Ph. Eur.
USP

Quality Level

600

product line

EMPROVE® API

form

solid

potency

2630 mg/kg LD50, skin (Rat)

pH

4.5-8.5 (20 °C, 50 g/L in H2O)

mp

176 °C (dec.) (lit.)

solubility

soluble

application(s)

liquid formulation
ophthalmics
pharmaceutical
semi-solid formulation
solid formulation

storage temp.

2-25°C

SMILES string

O.O.Cl[Ca]Cl

InChI

1S/Ca.2ClH.2H2O/h;2*1H;2*1H2/q+2;;;;/p-2

InChI key

LLSDKQJKOVVTOJ-UHFFFAOYSA-L

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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

Calcium chloride dihydrate is typically used in clinical nutrition and in infusion. Calcium Chloride dihydrate cryst. Emprove® API is manufactured according to ICH Q7 guidelines. A CEP and an US-DMF are available.

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
GHS07

Signal Word

Warning

Hazard Statements

H319

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

Regulatory Information

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Articles

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

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