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Merck

1.03669

SAFC

Glycine

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

Pharma Manufacturing

Synonym(s):

Gly, Aminoacetic acid, Aminoethanoic acid, Aminoacetic acid, Aminoethanoic acid, Glycocoll

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About This Item

Linear Formula:
NH2CH2COOH
CAS Number:
Molecular Weight:
75.07
Beilstein:
635782
MDL number:
UNSPSC Code:
12352209
EC Index Number:
200-272-2

This item is not able to be purchased as a guest user. For further information, please contact us at +420 225 296 100or

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Agency

BP
ChP
JP
Ph. Eur.
USP

Quality Level

vapor pressure

0.0000171 Pa ( 25 °C)

description

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

product line

EMPROVE® EXPERT

Assay

99.0-101.0% (calculated on dried substance, perchloric acid titration)

form

granular

technique(s)

inhibition assay: suitable

pH

5.9-6.4 (20 °C, 50 g/L in H2O)

pKa (25 °C)

(1) 2.35, (2) 9.60
2.35

mp

240 °C (dec.) (lit.)

density

1.161 g/cm3 at 20 °C

application(s)

liquid formulation
parenterals
pharma/biopharma processes
pharmaceutical

storage temp.

2-30°C

SMILES string

NCC(O)=O

InChI

1S/C2H5NO2/c3-1-2(4)5/h1,3H2,(H,4,5)

InChI key

DHMQDGOQFOQNFH-UHFFFAOYSA-N

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General description

Standard bulk materials often show a tendency for caking, clumping and dust formation which results in laborious weighing processes and manual de-caking processes with a negative impact on manufacturing efficiency. Due to its granulated form, granulated glycine is free-flowing and easy to handle. Its greatly reduced caking behavior facilitates processability, speeds up manufacturing processes and increases operator safety.
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

Glycine in general is widely used in the biopharma industry as a stabilizer, tonicity modifier, buffer and precipitating agent. It is also used as an emollient, emulsifying agent and solubilizer in solid and semi-solid formulations.
Due to its low microbial and endotoxin limits, Glycine granulated Emprove® Expert is especially suitable for high-risk applications.

Biochem/physiol Actions

Inhibitory neurotransmitter in spinal cord, allosteric regulator of NMDA receptors.

Legal Information

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

Application

Product No.
Description
Pricing

related product

Storage Class Code

11 - Combustible Solids

WGK

WGK 1

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable


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. Four document types are included with an Emprove® Program subscription:

Material Qualification Dossier

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Quality Management Dossier (Open Access)

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Operational Excellence Dossier

Available by subscription or for a fee

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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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Articles

Handling bulk powders at a large scale in the pharmaceutical, biopharmaceutical, and bioprocessing setting is challenging. Compared to powders, granulated materials experience far less caking, have better flowability, and are easier to handle, even after long-term storage.

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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