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Key Documents

1.04672

SAFC

Synthechol® Synthetic Cholesterol

EMPROVE® EXPERT, Ph. Eur., BP, JP, NF

Pharma Manufacturing

Synonym(s):

Cholesterol, 3β-Hydroxy-5-cholestene, 5-Cholesten-3β-ol

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About This Item

Empirical Formula (Hill Notation):
C27H46O
CAS Number:
Molecular Weight:
386.65
Beilstein:
1915888
MDL number:
UNSPSC Code:
12352104

biological source

synthetic

Quality Level

Agency

BP
JP
NF
Ph. Eur.

product line

EMPROVE® EXPERT

form

powder

bp

360 °C (lit.)

mp

~141 °C
147-149 °C (lit.)

density

1.067 g/mL at 25 °C (lit.)

suitability

suitable for (Suitable for formulation and manufacturing use)

application(s)

advanced drug delivery
controlled release
liquid formulation
parenterals
pharmaceutical

storage temp.

15-25°C

SMILES string

CC(C)CCC[C@@H](C)[C@H]1CC[C@H]2[C@@H]3CC=C4C[C@@H](O)CC[C@]4(C)[C@H]3CC[C@]12C

InChI

1S/C27H46O/c1-18(2)7-6-8-19(3)23-11-12-24-22-10-9-20-17-21(28)13-15-26(20,4)25(22)14-16-27(23,24)5/h9,18-19,21-25,28H,6-8,10-17H2,1-5H3/t19-,21+,22+,23-,24+,25+,26+,27-/m1/s1

InChI key

HVYWMOMLDIMFJA-DPAQBDIFSA-N

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General description

A GMP-scalable process which yields a high-quality lipid is essential to lipidic drug product development and manufacturing. We are highly specialized in synthesizing top-quality GMP lipids for pharmaceutical applications and gene therapy, focusing on tailored manufacturing to meet your specific needs. We also offer an off-the-shelf catalog with optimized stability, solubility, and handling characteristics.
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

Cholesterol is a major component of all biological cell membranes and is used as a stabilizer of lipid bilayers in many lipid-based formulations for the delivery of different APIs, such as small molecules and nucleic acids.
Synthetic cholesterol, Ph Eur, BP, JP, NF is ultra-pure and therefore suitable for divers formulations applications. Due to low batch to batch variability, very high purity, and lack of biological components, this product is optimal for highly sensitive applications such as nucleic acid delivery.
With a newly optimized manufacturing process, this product is available in quantities from grams to tons to support your development progress. A dual sourcing option is also possible.

Biochem/physiol Actions

Major component of all biological membranes; ~25% of total brain lipid is cholesterol.

Legal Information

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

Disclaimer

The substance 1.04672 has no REACH registration because the only supported use is the use in medicinal products for human or veterinary use or in food or feedingstuffs according to article 2 of the REACH Regulation (EC) No 1907/2006.

Storage Class Code

11 - Combustible Solids

WGK

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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