MICLAB 120 IPA Contamination Testing Procedure Pharmaceuticals quality assurance & validation procedures GMPSOP

Department	Micro Laboratory		Document no	MICLAB 120
Title	IPA (Isopropyl Alcohol) Contamination Test
Prepared by:		Date:		Supersedes:
Checked by:		Date:		Date Issued:
Approved by:		Date:		Review Date:

Document Owner

Micro Laboratory Manager

Purpose

To describe the test sometimes used to check the purity of the IPA used in the factory as a disinfectant.

Scope

The Laboratory Technician is responsible for carrying out this test.

Definition

IPA	Iso-propanol or 2- propanol
UV	Ultraviolet
HPLC	High Pressure Liquid Chromatography

EHS Statement

IPA is a flammable liquid.
Gloves and safety glasses should be worn.
Avoid breathing fumes.

Introduction A simple laboratory UV test can be done to check the consistency of the IPA. The test involves comparing the UV spectrum of the IPA sample with that of HPLC grade IPA from the Laboratory.

Procedure

1.1. UV Test

UV Conditions:

Wavelength 190 – 400 nm Slit width 2nm Data interval 0.85

Blank the UV spectrometer with Distilled Water.
Run a scan of the (undiluted) sample IPA using Distilled Water as the reference.
Run a scan of the Laboratory HPLC grade IPA in the same manner.
Compare the two spectra. The sample spectrum should be similar to that of the HPLC grade IPA. There should not be more than 0.3 AU difference between the two spectra.

Examples of Failed (Fig. 1) and Passed (Fig. 2) samples are shown below:

Figure 1 – Failed Sample

Figure 2 – Passed sample

Summary of Changes

Version #	Revision History
MICLAB 120	New

MICLAB 120 IPA Contamination Testing Procedure