Hydrochloric Acid Compounded Injection

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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1 DEFINITION

Hydrochloric Acid Compounded Injection contains NLT 90% and NMT 110% of the labeled amount of hydrochloric acid (HCl), equivalent to NLT 328 mg and NMT 401 mg of hydrochloric acid (HCl) in 100 mL.

Prepare Hydrochloric Acid Compounded Injection, 0.1 N, as follows (see Pharmaceutical Compounding—Sterile Preparations 〈797〉).

Prepare 1.0 N Hydrochloric Acid by adding Hydrochloric Acid to Purified Water in an appropriate volumetric flask with continuous stirring. Allow the solution to cool to room temperature, add sufficient Purified Water to bring to nal volume, and continue mixing for 1 min. Pass through a compatible filter of 0.45-µm pore size to reduce particulate matter load. Accurately measure the nonsterile 1.0 N Hydrochloric Acid with an appropriate glass or plastic device, and accurately dilute to nal volume with 0.45% or 0.9% Sodium Chloride Injection. Sterilize the solution by passing through a sterile acid-compatible membrane filter of 0.2-µm pore size into a sterile intravenous polypropylene container in an ISO Class 5 environment. [Note—This is a high-risk level compounded sterile preparation (CSP) that shall be prepared according to Pharmaceutical Compounding—Sterile Preparations 〈797〉.] (CN 1-May-2020)

2 ASSAY

Procedure

Sample: 25 mL

Blank: 25 mL of water

2.1 Titrimetric system

(See Titrimetry 〈541〉.)

Mode: Direct titration

Titrant: 0.5 N sodium hydroxide VS

Endpoint detection: Visual

2.2 Analysis

Place the Sample in a conical ask, add methyl red TS, and titrate with Titrant.

Calculate the weight of hydrochloric acid in 100 mL:

Result = [(V_S − V_B ) × N × F] × D

V_S = Titrant volume consumed by the Sample (mL)

V_B = Titrant volume consumed by the Blank (mL)

N = actual normality of the Titrant (mEq/mL)

F = equivalency factor, 36.46 mg/mEq

D = dilution factor, 4

Acceptance criteria: 328–401 mg in 100 mL

3 SPECIFIC TESTS

pH 〈791〉: 1.0–1.2

Sterility Tests 〈71〉: It meets the requirements when tested as directed under Test for Sterility of the Product to Be Examined, Membrane Filtration.

Bacterial Endotoxins Test 〈85〉: NMT 1.5 USP Endotoxin Units/mL

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4 ADDITIONAL REQUIREMENTS

Packaging and Storage: Package in a single-dose polypropylene container. Store at controlled room temperature or in a refrigerator.

Beyond-Use Date: If a sterility test and bacterial endotoxin test is passed, NMT 120 days when stored at controlled room temperature or in a refrigerator. In the absence of passing a sterility test and endotoxin test, the storage periods at controlled room temperature or cold temperature for high-risk level CSPs applies (see CSP Microbial Contamination Risk Levels in Pharmaceutical Compounding—Sterile Preparations 〈797〉). _{(CN 1-May-2020)}

Labeling: Label it Hydrochloric Acid Compounded Injection, 0.1 N. Label it to state that this is a single-dose container. Label it to state the Beyond-Use Date.