4.80592

Hydrochloric acid 10%

EMPROVE^® EXPERT Ph Eur,JP,NF

• Synonim(y): Hydrochloric acid solution, Hydrogen chloride solution
• Wzór liniowy: HCl
• Numer CAS: 7647-01-0
• Masa cząsteczkowa: 36.46
• UNSPSC Code: 12352301
• MDL number: MFCD00011324

Właściwości

• 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; downstream processes; pharma/biopharma processes
• storage temp.: 2-25°C
• SMILES string: Cl
• InChI: 1S/ClH/h1H
• InChI key: VEXZGXHMUGYJMC-UHFFFAOYSA-N

Opis

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

• Assay (alkalimetric): 9.5 - 10.0 %:
• Assay (alkalimetric): 10.0 - 10.5 % (w/v)
• Identity: passes test
• Color: ≤ 10 Hazen
• Appearance: passes test
• Bromide or iodide: passes test
• Free bromine or chlorine: passes test
• Free chlorine (Cl): ≤ 0.0001
• Sulfate (SO₄): ≤ 0.0005 %
• Sulphite (SO₃): ≤ 0.001 %
• Heavy metals (as Pb): ≤ 0.0001 %
• Residual solvents (ICH Q3C): ...excluded by production process
• Evaporation residue: ≤ 0.01
• Residue on ignition (as SO₄): ≤ 0.008 %
• Endotoxins: ≤ 2.5 I.U./ml

Lotnumber (raw material)

Filtered with 0.2 µm

Manufactured from Hydrochloric acid fuming 37% EMPROVE^® ESSENTIAL PhEur, BP, JP, NF and purified water acc. PhEur, JP.

Elemental 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, JP, NF

Legal Information

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

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Informacja o środkach bezpieczeństwa

• Piktogramy: GHS05,GHS07
• Słowo ostrzegawcze: Warning
• Kody zagrożeń: H290,H315,H319,H335
• Ostrzeżenia: P234 - P261 - P264 - P271 - P302 + P352 - P305 + P351 + P338
• Hazard Classifications: Eye Irrit. 2 - Met. Corr. 1 - Skin Irrit. 2 - STOT SE 3
• Narządy docelowe: Respiratory system
• Klasa składowania: 12 - Non Combustible Liquids