1.37118

L-Ornithine monohydrochloride

EMPROVE^® EXPERT, DAB

• Synonym(s): L-Ornithine monohydrochloride, (S)-2,5-Diaminopentanoic acid monohydrochlorid
• CAS Number: 3184-13-2
• Molecular Weight: 168.62
• MDL number: MFCD00064562

Properties

• Agency: DAB
• Quality Level: 500
• product line: EMPROVE^® EXPERT
• form: solid
• application(s): liquid formulation; pharmaceutical
• InChI: 1S/C5H12N2O2.ClH/c6-3-1-2-4(7)5(8)9;/h4H,1-3,6-7H2,(H,8,9);1H
• InChI key: GGTYBZJRPHEQDG-UHFFFAOYSA-N

Description

General description

For protein-based therapeutics, such as monoclonal antibodies (mAbs) or plasma derived proteins, often highly concentrated protein formulations are required to meet intended dosing regimens. However, this usually comes with elevated viscosities and presents a challenge in the manufacturing process and final formulation. Our Viscosity Reduction Excipient Platform reduces the viscosity and helps overcome challenges associated with highly concentrated protein solutions.
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

The Viscosity Reduction Platform is based on the combination of two new excipients, one amino acid component with one anionic component, that together can better reduce protein viscosity beyond levels achieved with single excipients. Also, combining the two components enables a balance of viscosity reduction and protein stabilization. L-Ornithine monohydrochloride Emprove^® Expert DAB is part of this new proprietary technology platform.

Packaging

1371180100 // 100 G Plastic bottle
1371181000 // 1 KG Plastic bottle
1371189010 // 10 KG PE sac, plastic bucket

Legal Information

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

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

Safety Information

• Storage Class Code: 11 - Combustible Solids
• WGK: WGK 1
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable