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1.01544

SAFC

L-Arginine monohydrochloride

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

Pharma Manufacturing

Synonym(s):

α-Amino-δ-guanidino valerianic acid hydrochloride, alpha-Amino-delta-guanidino valerianic acid hydrochloride, Arg, (S)-(+)-2-Amino-5-[(aminoiminomethyl)amino]pentanoic acid monohydrochloride, (S)-(+)-Arginine hydrochloride

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About This Item

Empirical Formula (Hill Notation):
C6H14N4O2 · HCl
CAS Number:
1119-34-2
Molecular Weight:
210.66
Beilstein:
3631658
MDL number:
MFCD00064550
UNSPSC Code:
12352209
EC Index Number:
214-275-1

Agency

BP
ChP
JP
Ph. Eur.
USP

Quality Level

500

vapor pressure

<1 Pa ( 20 °C)

product line

EMPROVE® EXPERT

Assay

98.5-101.0% dry basis (perchloric acid titration)

form

solid

pH

5.7 (20 °C, 100 g/L in H2O)

mp

>235 °C

solubility

water: 730 g/L at 20 °C

density

1.42 g/cm3 at 20 °C

anion traces

chloride (Cl-): 16.5-17.1%
sulfate (SO42-): ≤200 ppm

cation traces

As: ≤2 ppm
Fe: ≤10 ppm
NH4+: ≤200 ppm
heavy metals (as Pb): ≤10 ppm

application(s)

liquid formulation
parenterals
pharma/biopharma processes
pharmaceutical

storage temp.

2-30°C

SMILES string

Cl[H].N[C@@H](CCCNC(N)=N)C(O)=O

InChI

1S/C6H14N4O2.ClH/c7-4(5(11)12)2-1-3-10-6(8)9;/h4H,1-3,7H2,(H,11,12)(H4,8,9,10);1H/t4-;/m0./s1

InChI key

KWTQSFXGGICVPE-WCCKRBBISA-N

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General description

Chemicals play an important role in the stabilization of a biologic drug during its manufacturing and formulation process – for instance, by preventing aggregation. We offer a wide range of high-quality stabilizers, buffers and salts to successfully purify and formulate your biomolecules. Specifically developed for high-risk applications, they are low in bioburden and endotoxins.
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

Arginine hydrochloride has several applications in biopharma manufacturing such as an additive for protein refolding, aggregate suppression and buffer for chromatography.
Due to its low microbial and endotoxin limits, L-Arginine monohydrochloride Emprove® Expert is suitable for high-risk applications.

Biochem/physiol Actions

Substrate of nitric oxide synthase, which is converted to citrulline and nitric oxide (NO). Induces insulin release by a nitric oxide-dependent mechanism.

Legal Information

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

WGK

WGK 1

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Certificates of Analysis (COA)

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Articles

Use of Stabilizers and Surfactants to Prevent Protein Aggregation

This article outlines critical factors in long-term stability of proteins, and how different stabilizers protect again mechanical and thermal stress.

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Formulation

Learn more on mAb subcutaneous or intravenous formulation, and the relevant associated products, including excipients.

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