1.07430

L-Proline

EMPROVE^® EXPERT Ph Eur,JP,USP

• Sinónimos: L-Proline, Pro
• Número de CAS: 147-85-3
• Peso molecular: 115.13
• Número MDL: MFCD00064318
• Código UNSPSC: 12352209
• Número índice de la CE: 205-702-2

Propiedades

• Agency: JP; Ph. Eur.; USP
• Nivel de calidad: 500
• Línea del producto: EMPROVE^® EXPERT
• potencia: >5110 mg/kg LD₅₀, oral (Rat)
• pH: 5-7 (20 °C, 100 g/L in H₂O)
• mp: 220-222 °C (decomposition)
• solubilidad: 1500 g/L
• densidad: 1.35-1.38 g/cm³ at 25 °C
• densidad aparente: 500 kg/m³
• aplicaciones: parenterals
• temp. de almacenamiento: 2-30°C
• InChI: 1S/C5H9NO2/c7-5(8)4-2-1-3-6-4/h4,6H,1-3H2,(H,7,8)
• Clave InChI: ONIBWKKTOPOVIA-UHFFFAOYSA-N

Descripción

Descripción general

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.

Nota de análisis

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.

Información legal

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

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

Información de seguridad

• Código de clase de almacenamiento: 13 - Non Combustible Solids
• Clase de riesgo para el agua (WGK): WGK 1
• Punto de inflamabilidad (°F): Not applicable
• Punto de inflamabilidad (°C): Not applicable