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1.37156

Pyridoxine hydrochloride

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

Synonym(s):

Pyridoxine hydrochloride, Adermine hydrochloride, PN HCl, Pyridoxol hydrochloride, Vitamin B6 hydrochloride

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About This Item

Empirical Formula (Hill Notation):
C8H11NO3 · HCl
CAS Number:
58-56-0
Molecular Weight:
205.64
UNSPSC Code:
41116107
Beilstein/REAXYS Number:
3632435
MDL number:
MFCD00012807
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Quality Level

500

agency

BP, JP, Ph. Eur., USP

reg. compliance

FCC

product line

EMPROVE® EXPERT

mp

214-215 °C (lit.)

application(s)

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

storage temp.

15-25°C

SMILES string

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

InChI key

ZUFQODAHGAHPFQ-UHFFFAOYSA-N

General description

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.

Packaging

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

Legal Information

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

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pictograms

Corrosion
GHS05

signalword

Danger

hcodes

H318

Hazard Classifications

Eye Dam. 1

Storage Class

11 - Combustible Solids

wgk

WGK 1

flash_point_f

Not applicable

flash_point_c

Not applicable

Regulatory Information

新产品

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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

Strategies for the Development of Safe and Effective Pediatric Formulations

Medicine for children poses unique formulation challenges compared to adults. Consider developmental physiology and age specifics when designing pharmaceuticals. Quality issues can severely impact patient safety. Therefore, excipient quality, supplier selection, and supply chain security are crucial, particularly for pediatric formulations.

Viscosity Reduction in High Concentration TFF

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

Related Content

Pediatric Formulations

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.

 Viscosity-Reducing Excipients for Protein Formulation
User Guide - Experimental Procedures to Evaluate the Viscosity Reduction Platform

User Guide on Experimental Procedures to evaluate the viscosity reduction platform.

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Global Trade Item Number

SKUGTIN
137156010004065267030623
137156100004065267030630
137156901204065267030647