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1.37118

SAFC

L-Ornithine monohydrochloride

EMPROVE® EXPERT, DAB

Pharma Manufacturing

Synonym(s):

L-Ornithine monohydrochloride, (S)-2,5-Diaminopentanoic acid monohydrochlorid

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About This Item

CAS Number:
3184-13-2
Molecular Weight:
168.62
MDL number:
MFCD00064562
UNSPSC Code:
12352204

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

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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

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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Articles

Viscosity Reduction in High Concentration TFF

This overview describes how use of viscosity-reducing excipients can address viscosity challenges in high concentration tangential flow filtration (TFF) and improve process economics.

Addressing Viscosity Challenges for Subcutaneous Injections

This overview provides strategies for reducing the viscosity of high concentration drug formulations to enable subcutaneous injections for greater patient convenience and adherence.

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