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Key Documents

1.07430

SAFC

L-Proline

EMPROVE® EXPERT Ph Eur,JP,USP

Produzione farmaceutica

Sinonimo/i:

L-Proline, Pro

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About This Item

Numero CAS:
Peso molecolare:
115.13
Numero MDL:
Codice UNSPSC:
12352209
Numero indice EU:
205-702-2

agenzia

JP
Ph. Eur.
USP

Livello qualitativo

Nome Commerciale

EMPROVE® EXPERT

Potenza

>5110 mg/kg LD50, oral (Rat)

pH

5-7 (20 °C, 100 g/L in H2O)

Punto di fusione

220-222 °C (decomposition)

Solubilità

1500 g/L

Densità

1.35-1.38 g/cm3 at 25 °C

Densità bulk

500 kg/m3

applicazioni

parenterals

Temperatura di conservazione

2-30°C

InChI

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

Descrizione generale

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.

Risultati analitici

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.

Note legali

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

Codice della classe di stoccaggio

13 - Non Combustible Solids

Classe di pericolosità dell'acqua (WGK)

WGK 1

Punto d’infiammabilità (°F)

Not applicable

Punto d’infiammabilità (°C)

Not applicable


Certificati d'analisi (COA)

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