1.07430

SAFC

L-Proline

EMPROVE® EXPERT Ph Eur,USP

Synonym(s):
L-Proline, Pro
CAS Number:
Molecular Weight:
115.13
MDL number:
EC Index Number:
205-702-2

storage conditions

Store at +5°C to +30°C.

Quality Level

Agency/Method

JP
Ph. Eur.
USP

product line

EMPROVE® EXPERT

potency

>5110 mg/kg LD50, oral (Rat)

pH

5-7 (20 °C, 100 g/L in H2O)

mp

220-222 °C (decomposition)

solubility

1500 g/L

density

1.35-1.38 g/cm3 at 25 °C

bulk density

500 kg/m3

storage temp.

2-30°C

InChI

1S/C5H9NO2/c7-5(8)4-2-1-3-6-4/h4,6H,1-3H2,(H,7,8)

InChI key

ONIBWKKTOPOVIA-UHFFFAOYSA-N

General description

EMPROVE® EXPERT Ph Eur,USP

Analysis Note

Assay (perchloric acid titration, calculated on dried substance)99.0 - 101.0 %Identity (IR-spectrum)passes testIdentity (specific rotation)passes testAppearancewhite or almost white, crystalline powder or colorless crystalsAppearance of solution (50 g/l; water)clear and colorlessSpec. rotation (α 20/D, 40 g/l, water, calc. on dried substance)-84.0 to -86.0Spec. rotation (α 25/D, 40 g/l, water, calc. on dried substance)-84.3 to -86.3Chloride (Cl)≤ 200 ppmSulfate (SO₄)≤ 300 ppmFe (Iron)≤ 10 ppmMn (Manganese)≤ 25 ppmZn (Zinc)≤ 130 ppmRelated Compounds, total (TLC)≤ 0.5 %Ninhydrin-positive substances (LC)(any ninhydrin-positive impurity)≤ 0.2 %Ninhydrin-positive substances (LC) (ammonium (570 nm))≤ 0.02 %Ninhydrin-positive substances (LC)(total impurities)≤ 0.5 %Residual solvents (ICH Q3C)excluded by manufacturing processSulfated ash (600 °C)≤ 0.1 %Loss on Drying (105 °C)≤ 0.4 %Bacterial endotoxins≤ 5 I.U./gTotal aerobic microbial count (TAMC)≤ 100 CFU/gTotal combined yeasts/moulds count (TYMC)≤ 100 CFU/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 Ph. Eur., USP.

Legal Information

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

storage_class_code

13 - Non Combustible Solids

WGK Germany

WGK 1

Flash Point F

Not applicable

Flash Point C

Not applicable

Certificate of Analysis

Certificate of Origin

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

Free of charge - Sign in to download

Quality Management Dossier

Available by subscription or for a fee

Operational Excellence Dossier

Available by subscription or for a fee

Learn more about the benefits an Emprove® Program subscription can provide
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.

Our team of scientists has experience in all areas of research including Life Science, Material Science, Chemical Synthesis, Chromatography, Analytical and many others.

Contact Technical Service