Quality Segment
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
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.
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
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
signalword
Warning
hcodes
Hazard Classifications
Eye Irrit. 2 - Met. Corr. 1 - Skin Irrit. 2 - STOT SE 3
target_organs
Respiratory system
存储类别
12 - Non Combustible Liquids
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