4.80592

Salzsäure 10%

EMPROVE^® EXPERT Ph Eur,JP,NF

• Synonym(e): Salzsäure -Lösung, Chlorwasserstofflösung
• Lineare Formel: HCl
• CAS-Nummer: 7647-01-0
• Molekulargewicht: 36.46
• UNSPSC Code: 12352301
• MDL number: MFCD00011324

Eigenschaften

• Quality Segment: 500
• agency: JP, NF, Ph. Eur.
• product line: EMPROVE^® EXPERT
• assay: 10.0-10.5% (w/v), 9.5-10.0%
• form: liquid
• concentration: ≥10 -< 20%
• impurities: Residual solvents (ICH Q3C) (excluded by production process), ≤0.0001% Free chlorine (Cl), ≤0.0005% Sulfate (SO₄), ≤0.001% Sulfite (SO₃), ≤0.008% Residue on ignition (as SO₄), ≤0.01% Evaporation residue, ≤2.5 IU/mL Endotoxins
• pH: <1 (20 °C in H₂O)
• bp: 102 °C
• density: 1.05 g/cm³ at 20 °C
• application(s): cleaning in place; pharma/biopharma processes
• storage temp.: 2-25°C
• SMILES string: Cl
• InChI: 1S/ClH/h1H
• InChI key: VEXZGXHMUGYJMC-UHFFFAOYSA-N

Beschreibung

General description

Every bio-manufacturing process involves buffer preparation, pH adjustment, and cleaning. All our respective GMP (IPEC/EXCiPACT) products are manufactured under Excipient GMP conditions and feature low bioburden levels, backed by our Emprove^® Program for exceptional quality and documentation support.

As a result, you can integrate our products directly into your biopharmaceutical production process. In addition to our comprehensive portfolio, we also offer custom manufacturing services to meet your exact needs.

Application

10% Hydrochloric acid is a high-purity, pharmaceutical-grade acid solution specifically designed for use in regulated environments such as biopharmaceutical manufacturing. It can be used as:

• To adjust the pH of process solutions, buffers, and media during upstream and downstream processing.
• In cleaning-in-place (CIP) procedures for equipment and piping, ensuring removal of residues and maintaining aseptic conditions.

Features and Benefits

• Comprehensive, up-to-date documentation you need to navigate regulatory challenges, manage risks, and improve processes.
• Suitable for higher-risk applications where the lowest microbiological and endotoxin levels are of utmost importance.
• Emprove^® products are designed to facilitate compliance with global regulations (e.g., ICH Q7, EU GMP, USP, EP).
• Detailed supply chain and manufacturing information helps ensure traceability and continuity, which is critical for GMP manufacturing.

Analysis Note

Gehalt (alkalimetrisch):
9,5 - 10,0 %
: 10,0 - 10,5 % (w/v)
Identität: entspricht
Farbe: ≤ 10 Hazen
Aussehen: entspricht
Bromid oder Iodid: entspricht
Freies Brom oder Chlor: entspricht
Freies Chlor (Cl): ≤ 0,0001
Sulfat (SO₄): ≤ 0,0005 %
Sulfit (SO₃): ≤ 0,001 %
Schwermetalle (als Pb): ≤ 0,0001 %
As (Arsen): ≤ 0,000015 %
Hg (Quecksilber): ≤ 0,0000010 %
Lösungsmittel-Rückstände (ICH Q3C): ...ausgeschlossen durch den Herstellprozess
Abdampfrückstand: ≤ 0,01
Glührückstand (als SO₄): ≤ 0,008 %
Endotoxine: ≤ 2,5 I.U./ml
Chargennummer (Rohstoff):
Filtriert durch 0,2 µm Filter
Hergestellt aus Salzsäure rauchend 37 % EMPROVE^® ESSENTIAL Ph Eur, BP, JP, NF und Reinwasser gemäß Ph Eur, JP.

Elementverunreinigungen gemäß der Leitlinie ICH Q3D (Guideline for Elemental Impurities) sind in der Spezifikation berücksichtigt. Elemente der Klassen 1-3 werden nicht oberhalb des Option-1-Limit gemäß ICH Q3D erwartet, wenn diese nicht spezifiziert und gekennzeichnet (*) sind.
Entspricht Ph Eur, JP, NF

Legal Information

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

Sicherheitshinweise

• pictograms: GHS05,GHS07
• signalword: Warning
• hcodes: H290,H315,H319,H335
• pcodes: P234 - P261 - P264 - P271 - P302 + P352 - P305 + P351 + P338
• Hazard Classifications: Eye Irrit. 2 - Met. Corr. 1 - Skin Irrit. 2 - STOT SE 3
• target_organs: Respiratory system
• Lagerklasse: 12 - Non Combustible Liquids