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
• Empirical Formula (Hill Notation): C₆H₉N₃O₂ · HCl · H₂O
• CAS Number: 5934-29-2
• Molecular Weight: 209.63
• Beilstein: 4168261
• MDL number: MFCD00151027
• EC Index Number: 211-438-9

Properties

• Agency: BP; ChP; JP; Ph. Eur.
• Quality Level: 500
• 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
• 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

Description

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

Safety Information

• Pictograms: GHS07
• Signal Word: Warning
• Hazard Statements: H319
• Precautionary Statements: P264 - P280 - P305 + P351 + P338 - P337 + P313
• Hazard Classifications: Eye Irrit. 2
• Storage Class Code: 11 - Combustible Solids
• WGK: WGK 1
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable