MilliporeSigma

1.00286

SAFC

L-Glutamine

EMPROVE® EXPERT, DAB, JP, USP

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Synonym(s):
L-Glutamic acid-5-amide, Gln, (S)-2,5-Diamino-5-oxopentanoic acid, L-Glutamic acid 5-amide, Levoglutamide
Linear Formula:
H2NCOCH2CH2CH(NH2)CO2H
CAS Number:
Molecular Weight:
146.14
Beilstein:
1723797
MDL number:
EC Index Number:
200-292-1

Agency

DAB
JP
USP

Quality Level

description

EMPROVE® EXPERT DAB,USP

product line

EMPROVE® EXPERT

form

solid

potency

7500 mg/kg LD50, oral (Rat)

technique(s)

API processing | cocrystal formation: suitable
API processing | salt formation: suitable

pH

4.0-6.0 (20 °C, 25 g/L in H2O)

mp

185 °C (dec.) (lit.)

solubility

100 g/L

density

1.47 g/cm3 at 20 °C

bulk density

640 kg/m3

storage temp.

2-30°C

SMILES string

N[C@@H](CCC(N)=O)C(O)=O

InChI

1S/C5H10N2O3/c6-3(5(9)10)1-2-4(7)8/h3H,1-2,6H2,(H2,7,8)(H,9,10)/t3-/m0/s1

InChI key

ZDXPYRJPNDTMRX-VKHMYHEASA-N

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This Item
76523PHR11251.00289
L-Glutamine EMPROVE® EXPERT, DAB, JP, USP

SAFC

1.00286

L-Glutamine

L-Glutamine certified reference material, TraceCERT®, Manufactured by: Sigma-Aldrich Production GmbH, Switzerland

Supelco

76523

L-Glutamine

L-Glutamine Pharmaceutical Secondary Standard; Certified Reference Material

Supelco

PHR1125

L-Glutamine

L-Glutamine for biochemistry

Millipore

1.00289

L-Glutamine

form

solid

form

-

form

-

form

solid

technique(s)

API processing | cocrystal formation: suitable, API processing | salt formation: suitable

technique(s)

HPLC: suitable, gas chromatography (GC): suitable

technique(s)

HPLC: suitable, gas chromatography (GC): suitable

technique(s)

-

mp

185 °C (dec.) (lit.)

mp

185 °C (dec.) (lit.)

mp

185 °C (dec.) (lit.)

mp

185 °C (dec.) (lit.)

solubility

100 g/L

solubility

-

solubility

-

solubility

100 g/L

storage temp.

2-30°C

storage temp.

-

storage temp.

2-30°C

storage temp.

2-30°C

General description

Our SAFC® portfolio of high-quality products for biopharmaceutical processing withstands strict quality control procedures and is produced according to MQ-500 requirements as defined by the M-Clarity program.

M-Clarity Program

As part of our EMPROVE® Program, our raw materials are offered with EMPROVE® Dossiers which provide comprehensive, up-to-date documentation to help you navigate regulatory challenges, manage risks, and improve your manufacturing processes.

Our comprehensive portfolio of upstream process chemicals not only provides biopharmaceutical manufacturers with high-quality raw materials for production of classical and novel therapies, but also helps them get to market faster and simplify regulatory challenges. Trust us to deliver supply chain transparency and reliable sourcing around the globe, streamlining your product qualification with best-in-class regulatory support and service.

Biochem/physiol Actions

L-Glutamine is an essential amino acid that is a crucial component of culture media that serves as a major energy source for cells in culture. L-Glutamine is very stable as a dry powder and as a frozen solution. In liquid media or stock solutions, however, L-glutamine degrades relatively rapidly. Optimal cell performance usually requires supplementation of the media with L-glutamine prior to use.

Analysis Note

Assay (perchloric acid titration, calculated on dried substance)99.0 - 101.0 %Identity (IR-spectrum)passes testAppearancewhite to almost white, fine powderAppearance of solution (25 g/l; CO₂-free water)clear and colorlessSpec. rotation (α 20/D, 100 g/l, hydrochloric acid 2 mol/l, calc. on dried substance)+31.5 to +33.0Spec. rotation (α 20/D, 40 g/l, water, calc. on dried substance)+6.3 to +7.3pH (25 g/l; CO₂-free water)4.0 - 6.0Chloride (Cl)≤ 200 ppmSulfate (SO₄)≤ 200 ppmHeavy metals (as Pb)≤ 10 ppmCu (Copper)≤ 25 ppmFe (Iron)≤ 10 ppmFe (Iron) (ICP)≤ 10 ppmMn (Manganese)≤ 25 ppmNi (Nickel)≤ 2 ppmZn (Zinc)≤ 130 ppmNH₄ (Ammonium)≤ 0.1 %Ninhydrin - positive substances (TLC)≤ 0.5 %Residual solvents (ICH Q3C)excluded by manufacturing processSulfated ash (600 °C)≤ 0.1 %Loss on drying (105 °C; 3 h)≤ 0.3 %Bacterial endotoxins≤ 2.0 I.U./gElemental impurity specifications have been set considering ICH Q3D (Guideline for Elemental Impurities). Class 1-3 elements are not likely to be present above the ICH Q3D option 1 limit, unless specified and indicated (*).Corresponds to DAB, USP

Legal Information

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

Storage Class Code

13 - Non Combustible Solids

WGK

WGK 1

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable


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