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Merck
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Key Documents

1.37156

SAFC

Pyridoxine hydrochloride

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

Fabrication pharma

Synonyme(s) :

PN HCl, Pyridoxol hydrochloride

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About This Item

Formule empirique (notation de Hill):
C8H11NO3 · HCl
Numéro CAS:
Poids moléculaire :
205.64
Numéro Beilstein :
3632435
Numéro MDL:
Code UNSPSC :
41116107

Agence

BP
JP
Ph. Eur.
USP

Niveau de qualité

Conformité réglementaire

FCC

Gamme de produits

EMPROVE® EXPERT

Pf

214-215 °C (lit.)

Application(s)

clinical nutrition
liquid formulation
parenterals
pharmaceutical
vitamins, nutraceuticals, and natural products

Température de stockage

15-25°C

Chaîne SMILES 

Cl[H].Cc1ncc(CO)c(CO)c1O

InChI

1S/C8H11NO3.ClH/c1-5-8(12)7(4-11)6(3-10)2-9-5;/h2,10-12H,3-4H2,1H3;1H

Clé InChI

ZUFQODAHGAHPFQ-UHFFFAOYSA-N

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Description générale

For protein-based therapeutics, such as monoclonal antibodies (mAbs) or plasma derived proteins, often highly concentrated protein formulations are required to meet intended dosing regimens. However, this usually comes with elevated viscosities and presents a challenge in the manufacturing process and final formulation. Our Viscosity Reduction Excipient Platform reduces the viscosity and helps overcome challenges associated with highly concentrated protein solutions.
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

The Viscosity Reduction Platform is based on the combination of two new excipients, one amino acid component with one anionic component, that together can better reduce protein viscosity beyond levels achieved with single excipients. Also, combining the two components enables a balance of viscosity reduction and protein stabilization. Pyridoxine hydrochloride Emprove® Expert is part of this new proprietary technology platform. Also, Pyridoxine hydrochloride (Vitamin B6) is used in clinical nutrition for treatment of vitamin B6 deficiency, anemia, mental retardation, Parkinson′s syndrome, gestational diabetes, tetanus and atherosclerosis.

Conditionnement

1.37156.0100 / 100g / PE bottle
1.37156.1000 / 1kg / PE bottle
1.37156.9012 / 12kg / PE bucket

Informations légales

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

Pictogrammes

Corrosion

Mention d'avertissement

Danger

Mentions de danger

Conseils de prudence

Classification des risques

Eye Dam. 1

Code de la classe de stockage

11 - Combustible Solids

Classe de danger pour l'eau (WGK)

WGK 1

Point d'éclair (°F)

Not applicable

Point d'éclair (°C)

Not applicable


Certificats d'analyse (COA)

Recherchez un Certificats d'analyse (COA) en saisissant le numéro de lot du produit. Les numéros de lot figurent sur l'étiquette du produit après les mots "Lot" ou "Batch".

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Articles

This overview describes how use of viscosity-reducing excipients can address viscosity challenges in high concentration tangential flow filtration (TFF) and improve process economics.

This overview describes how use of viscosity-reducing excipients can address viscosity challenges in high concentration tangential flow filtration (TFF) and improve process economics.

This overview describes how use of viscosity-reducing excipients can address viscosity challenges in high concentration tangential flow filtration (TFF) and improve process economics.

This overview describes how use of viscosity-reducing excipients can address viscosity challenges in high concentration tangential flow filtration (TFF) and improve process economics.

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Contenu apparenté

Developing formulations specifically for infants and children is increasingly important. To help you master these challenges effectively, we offer an extensive portfolio of well-established high-quality excipients and APIs for pediatric pharmaceutical formulations that are proven in practice.

Developing formulations specifically for infants and children is increasingly important. To help you master these challenges effectively, we offer an extensive portfolio of well-established high-quality excipients and APIs for pediatric pharmaceutical formulations that are proven in practice.

Notre équipe de scientifiques dispose d'une expérience dans tous les secteurs de la recherche, notamment en sciences de la vie, science des matériaux, synthèse chimique, chromatographie, analyse et dans de nombreux autres domaines..

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