MilliporeSigma
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1.04354

SAFC

L-Histidine monohydrochloride monohydrate

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

Synonym(s):
L-α-Amino-β-(4-imidazolyl)propionic acid monohydrochloride, His
Empirical Formula (Hill Notation):
C6H9N3O2 · HCl · H2O
CAS Number:
Molecular Weight:
209.63
Beilstein:
4168261
MDL number:
EC Index Number:
211-438-9

Quality Level

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)

biopharma process and formulation
liquid formulation
parenterals
pharmaceutical

storage temp.

2-30°C

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

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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

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

Pictograms

Exclamation mark

Signal Word

Warning

Hazard Statements

Hazard Classifications

Eye Irrit. 2

Storage Class Code

11 - Combustible Solids

WGK

WGK 1

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Certificate of Analysis

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Certificate of Quality

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What is the Emprove® Program?

The Emprove® Program is a system providing comprehensive and thorough documentation of our filters and single-use components, pharma raw materials, and starting materials.

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Why are these documents unavailable?
Emprove® Dossiers contain information intended to support the registration process and risk assessment activities of pharmaceutical producers and contain confidential information. Please contact us if you would like access.

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