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4.80592

Hydrochloric acid 10%

EMPROVE® EXPERT Ph Eur,JP,NF

Synonym(s):

Hydrochloric acid solution, Hydrogen chloride solution

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About This Item

Linear Formula:
HCl
CAS Number:
7647-01-0
Molecular Weight:
36.46
UNSPSC Code:
12352301
MDL number:
MFCD00011324
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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

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

pictograms

CorrosionExclamation mark
GHS05,GHS07

signalword

Warning

Hazard Classifications

Eye Irrit. 2 - Met. Corr. 1 - Skin Irrit. 2 - STOT SE 3

target_organs

Respiratory system

Storage Class

12 - Non Combustible Liquids

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