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Merck

1.04354

L-Histidine monohydrochloride monohydrate

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

Synonym(s):

His, L-α-Amino-β-(4-imidazolyl)propionic acid monohydrochloride

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About This Item

Empirical Formula (Hill Notation):
C6H9N3O2 · HCl · H2O
CAS Number:
Molecular Weight:
209.63
EC Index Number:
211-438-9
UNSPSC Code:
12352107
Beilstein/REAXYS Number:
4168261
MDL number:

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SMILES string

O.Cl.N[C@@H](Cc1c[nH]cn1)C(O)=O

InChI

1S/C6H9N3O2.ClH.H2O/c7-5(6(10)11)1-4-2-8-3-9-4;;/h2-3,5H,1,7H2,(H,8,9)(H,10,11);1H;1H2/t5-;;/m0../s1

InChI key

CMXXUDSWGMGYLZ-XRIGFGBMSA-N

agency

BP, ChP, JP, Ph. Eur.

vapor pressure

<1 hPa ( 20 °C)

product line

EMPROVE® EXPERT

assay

98.5-101.0% (alkalimetric), 99.0-101.0% (perchloric acid titration)

form

solid

pH

3.5-4.5 (20 °C, 100 g/L in H2O)

mp

254 °C (dec.) (lit.)

solubility

149.55 g/L

density

1.49 g/cm3 at 20 °C

application(s)

liquid formulation
parenterals
pharma/biopharma processes
pharmaceutical

storage temp.

2-30°C

Quality Level

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1 of 4

This Item
H0755000H5659H4036
application(s)

liquid formulation
parenterals
pharma/biopharma processes
pharmaceutical

application(s)

pharmaceutical (small molecule)

application(s)

-

application(s)

pharmaceutical (small molecule)

agency

BP, JP, ChP, Ph. Eur.

agency

-

agency

meets EP testing specifications

agency

-

form

solid

form

-

form

crystalline powder

form

powder

assay

98.5-101.0% (alkalimetric), 99.0-101.0% (perchloric acid titration)

assay

-

assay

98.5-101.0%

assay

≥98.5%

solubility

149.55 g/L

solubility

-

solubility

H2O: 100 mg/mL

solubility

H2O: 50 mg/mL

product line

EMPROVE® EXPERT

product line

-

product line

BioXtra

product line

-

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

Histidine monohydrochloride is used in biopharmaceutical manufacturing as a buffer in formulation. It is often used along with histidine to prepare histidine buffer with the desired pH value.
Due to its low microbial and endotoxin limits, L-Histidine monohydrochloride monohydrate Emprove® Expert is especially suitable for high-risk applications.

Legal Information

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

Storage Class

11 - Combustible Solids

wgk

WGK 1

flash_point_f

Not applicable

flash_point_c

Not applicable


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Articles

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

Related Content

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

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