MilliporeSigma
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1.00590

SAFC

Glycine

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

Synonym(s):
Glycine, Gly, Aminoacetic acid, Aminoethanoic acid, Aminoacetic acid, Aminoethanoic acid, Glycocoll
Linear Formula:
NH2CH2COOH
CAS Number:
Molecular Weight:
75.07
Beilstein:
635782
MDL number:
EC Index Number:
200-272-2

Quality Level

Agency

BP
ChP
JP
Ph. Eur.
USP

vapor pressure

0.0000171 Pa ( 25 °C)

description

EMPROVE® EXPERT Ph Eur,BP,JP,USP

product line

EMPROVE® EXPERT

assay

98.5-101.0% (calculated on dried substance, perchloric acid titration)

form

crystalline
solid

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.)

solubility

soluble 250 g/L

density

1.161 g/cm3 at 20 °C

application(s)

biopharma process and formulation
liquid formulation
parenterals
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

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

Glycine is an amino acid which is used widely in the biopharma industry as 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 cryst. 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

Disclaimer

The substance 1.00590 has no REACH registration because the only supported use is the use in medicinal products for human or veterinary use or in food or feedingstuffs according to article 2 of the REACH Regulation (EC) No 1907/2006.

Storage Class Code

11 - Combustible Solids

WGK

WGK 1

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Certificate of Analysis

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Certificate of Quality

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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.

Material Qualification Dossier

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Quality Management Dossier

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Operational Excellence Dossier

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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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