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Safety Information

1.04352

SAFC

L-Histidine

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

Pharma Manufacturing

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Synonym(s):
His, (S)-2-Amino-3-(4-imidazolyl)propionic acid, NSC 137773
Empirical Formula (Hill Notation):
C6H9N3O2
CAS Number:
Molecular Weight:
155.15
Beilstein:
84088
MDL number:
UNSPSC Code:
12352209
EC Index Number:
200-745-3

Agency

ChP
JP
Ph. Eur.
USP

Quality Level

product line

EMPROVE® EXPERT

form

solid

technique(s)

API processing | cocrystal formation: suitable

pH

7.7 (20 °C, 10 g/L in H2O)

mp

282 °C (dec.) (lit.)

application(s)

liquid formulation
parenterals
pharma/biopharma processes
pharmaceutical

storage temp.

2-30°C

SMILES string

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

InChI

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

InChI key

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

Biochem/physiol Actions

Precursor of histamine by action of histidine decarboxylase.

Legal Information

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

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable


Regulatory Listings

Regulatory Listings are mainly provided for chemical products. Only limited information can be provided here for non-chemical products. No entry means none of the components are listed. It is the user’s obligation to ensure the safe and legal use of the product.

JAN Code

1043524107:
1043521000:
1043523010:
1043520001:
1043520500:
1043529010:
1043520100:
1043520000:
1043521000BWT:
1043520403:


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

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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