4.80592

Ácido clorhídrico al 10%

EMPROVE^® EXPERT Ph Eur,JP,NF

• Sinónimos: Ácido clorhídrico solution, Disolución de cloruro de hidrógeno, Cloruro de hidrógeno solution
• Fórmula lineal: HCl
• Número CAS: 7647-01-0
• Peso molecular: 36.46
• UNSPSC Code: 12352301
• MDL number: MFCD00011324

Propiedades

• 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

Descripción

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

Valoración (alcalimétrica):
9,5 - 10,0 %
: 10,0 - 10,5 % (p/v)
Identidad: pasa la prueba
Color: ≤ 10 Hazen
Aspecto: pasa la prueba
Bromuros o yoduros: pasa la prueba
Bromo o cloro libres: pasa la prueba
Cloro libre (Cl): ≤ 0,0001
Sulfatos (SO₄): ≤ 0,0005 %
Sulfitos (SO₃): ≤ 0,001 %
Metales pesados (como Pb): ≤ 0,0001 %
As (Arsénico): ≤ 0,000015 %
Hg (Mercurio): ≤ 0,0000010 %
Disolventes residuales (ICH Q3C): ...excluidos por el proceso de producción
Residuos de evaporación: ≤ 0,01
Residuos tras ignición (como SO₄): ≤ 0,008 %
Endotoxinas: ≤ 2,5 UI/ml
Número de lote (materias primas):
Filtrado con 0,2 µm
Fabricado a partir de ácido clorhídrico fumante al 37 % EMPROVE^® ESSENTIAL Ph Eur, BP, JP, NF y agua purificada según la PhEur, JP.

Las especificaciones de las impurezas elementales se han establecido considerando la ICH Q3D (Directriz de impurezas elementales). No es probable que los elementos de clase 1-3 estén presentes por encima del límite de la opción 1 de las ICH Q3D, salvo que se especifique y se indique (*).
Se ajusta a la Ph Eur, la JP, la NF

Legal Information

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

Información de seguridad

• 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
• Clase de almacenamiento: 12 - Non Combustible Liquids