Shimadzu Analytical Technologies for

This booklet is a compilation of Shimadzu analytical technologies and applications that will help our customers respond to the COVID-19 pandemic- such as research and quality control testing of drugs, disinfectants and personal protective equipment.

Disinfectants and Personal Protective Equipment (PPE)

Hand Sanitizer | Composition Analysis and Quality Assessment

World Health Organization (WHO) recommends washing hands with soap and water or using analcohol-based hand sanitizer as one of the basic protective measures against COVID-19. U.S. CDChave recommended sanitizers with 60–95% alcohol as the most effective composition of sanitizers.Additionally, with concerns over product fraud or fake substances used in the manufacturing ofsanitizers, the analysis of key active ingredients, such as alcohol, in sanitizers is crucial.

Shimadzu FTIR IRSpirit™ and GC Nexis-2030 provide ready to use simple methodology for themeasurement of ethanol and isopropyl alcohol (IPA) in hand sanitizers.

IRSpirit with QATR™ –SProvides a simple methodology Drop and Click workflow for thequantitation of ethanol or IPA in sanitizers. The Drop and Click workflowenables:• Fast results, under 1 min analysis time• No or minimal sample preparation required• Excellent data quality and reproducibility• Low running cost and minimal instrument maintenance

Gas Chromatograph GC-2030• Ideal for the analysis of volatile compounds

• Determination of purity of ethanol in sanitizers based on the Chinese

National standards “Hygienic standard for alcohol disinfectants”

(GB/T 26373-2010) to fulfil the Chinese Pharmacopoeia (CIP 2010 version 2)

Method Development

Testing of pharmacopoeial ethanol (disinfectant ethanol)

Ethanol has antimicrobial properties and issold as a disinfectant product at optimizedconcentrations. Quality control of alcohol as amedical product is carried out throughverification testing methods stipulated byvarious pharmacopoeias. As part of anagreement, the procedures for verificationtesting of ethanol or anhydrous ethanol indisinfectants are roughly the same in theJapanese (JP), United States (USP) andEuropean (EP) pharmacopoeias.

Verification test – component identification via the infra-red absorption spectrum.

In the verification testing of ethanol andanhydrous ethanol, identification ofcomponents is carried out using Fouriertransform infra-red spectroscopy (FT-IR).Reference spectra are compared with thespectra of the target compounds. TheJapanese Pharmacopeia (JP) specifies aliquid membrane technique test, and below isa measurement example of ethanol andanhydrous ethanol using a liquid cell (KRS-5window disk).

> Verification testing of ethanol and anhydrousethanol in accordance with pharmacopoeias

Purity test – analysis of volatile impurities

Volatile impurities in ethanol are detected witha gas chromatograph (GC). Methanol,acetaldehyde, acetal, benzene, etc. arechecked as impurities. An appropriateinstrument configuration is required to detectthe specified 2 vol ppm limit of trace benzeneand obtain good separation for acetaldehydeand methanol (separation of 1.5 or higher).The testing of disinfectant ethanol is coveredunder the general protocol for purity testing ofethanol.

Example analysis of volatile impurities in ethanol

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UV absorbance test – impurity analysis

The absorbance spectrum of an ethanol sample is used to test for the presence of impurities. A UV-Visspectrometer is used at a wavelength range of 235-340 nm with water as a reference sample. Theabsorbance at three points (240 nm, 250-260 nm, 270-340nm) is checked as being below certaintolerance values (0.40, 0.30, and 0.10 respectively).

240nm 250-260nm 270-340nm

File name Overall evaluation

Absorbance

Evaluation

Absorbance

Evaluation

Absorbance

Evaluation

disinfectant_ethanol.vspd

Pass 0.124 Pass 0.052 Pass 0.016 Pass

Disinfectants and Personal Protective Equipment (PPE)

Mask | Techniques for Safety and Quality Assurance

Masks can prevent spread of viruses (e.g. respiratory infections) and minimise exposure to airborneparticles. However, there are various types of face masks and the quality of masks generally dependson the materials used. Additionally, masks have to be sterile and the disinfection process may involvethe use of toxic chemicals. To curb the spread of COVID-19 virus successfully, there is a crucial needto ensure the safety and quality of masks used by medical professionals and the general public.

Measurement of Ethylene Oxide (a sterilant) Using Headspace GasChromatography (HS-GC)

Identification and Verification of Fake and Inferior Masks Using FTIR (IRSpirit™)

Quality and relevance of a mask is heavily determined by the multiple layers of material or fabric which function as differential successive filters

Medical equipment and surgical masks are commonlysterilized with ethylene oxide at room temperature.However being a toxic carcinogen, there are strictrequirements on residue Indicators for single usemedical device products.

Shimadzu HS-GC are ideal for the measurement of residual ethylene oxide in masks and can detectthe specified range of maximum allowable residual amount in standards such as:• National standards Biological Evaluation of Medical Devices Part VII: Ethylene Oxide SterilizationResidues (GB / T16886.7-2015)• International standard ISO 10993.7-2008 (Biological Evaluation of Medical Devices)

IRSpirit™ (FTIR) is a quick and easy technique toexamine and confirm the identity of the layers in amask based on their characteristic infra-red (IR)spectrum. Even for masks with blended fabrics, theIRSpirit with LabSolutions IR delivers highly precisesearch results equipped with:• 4 high-performance search methods (spectralsearch, peak search, text search and combinationsearch)• Libraries containing approximately 12,000 spectra

Non-woven layer

Meltblown filter

Non-woven layer

Outer LayerHydrophobicnon-woven layer

Middle LayerMeltblown filter

Inner LayerHydrophobicnon-woven layer

Headspace Gas Chromatography (HS-GC)

How Safe is Your Mask?

S-GC-F25a

Ethylene Oxide

Headspace Gas-Chromatography (HS-GC)

Surgical masks are typically sterilized with ethylene oxide at room temperature. However, ethylene oxide is a carcinogen. There are strict requirements on the ethylene oxide residue in single-use sterile medical device products. Both ISO 10993.7-2008 (Biological evaluation of medical devices) and China's National standard "Biological Evaluation of Medical Devices Part VII: Ethylene Oxide Sterilization Residues" (GB / T16886.7-2015) specify the maximum allowable residual amount of ethylene oxide. Shimadzu HS-GC is most suited for measurement of ethylene oxide in safety masks

Methodology involves simple sample preparation of transferring 1 g of sample into headspace bottle followed by sealing for testing. Excellent linearity was achieved for calibration curve ranging from 0.2-10 ug standard, along with reproducibility of 2.64% for 6 injections of 0.4 ug ethylene oxide.

2.5 5.0 7.5 10.0 12.5 min

25000

50000

75000

uVDET1

0

ethylene oxide

Chromatogram showing ethylene oxide measurement in standard sample,with calibration curve of 0.2 – 10 ug in the insert.

Easy to use | Minimal sample preparation | High performance | Rugged

0.0 5.0 Conc.

25000

50000

75000

100000

Area

0

GC Condition

Injector Split @ 220 °C ; Ratio 10:1

Oven temp.program

Detector TCD @ 250 °C

40°C (3 min) @ 5 °C/minto 85°C @ 30 °C/min to 200°C (2 min)

ColumnSH-Rxi™-624Sil MS60 m, 0.32 mm ID, df=1.8 µm (P/N: 221-75963-60)

HS ConditionR2 = 0.9991

Equilb. time

Load time

Equilb. temp.

30 min

0.5 min

100 °C

70 °C

110 °C

Sample line temp.

Transfer line temp.

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Shimadzu (Asia Pacific) Pte Ltd.

For Research Use Only. Not for use in diagnostic procedures. This publication may contain references to products that are not available in your country. Please contact us to check the availability of these products in your country.Company names, product/service names and logos used in this publication are trademarks and trade names of Shimadzu Corporation or its affiliates, whether or not they are used with trademark symbol “TM” or “®”. Third-party trademarks and trade names may be used in this publication to refer to either the entities or their products/services. Shimadzu disclaims any proprietary interest in trademarks and trade names other than its own.

The contents of this publication are provided to you “as is” without warranty of any kind, and are subject to change without notice. Shimadzu does not assume any responsibility or liability for any damage, whether direct or indirect, relating to the use of this publication.

Versatility with varied samples Great for High-throughput routine labs

20 vials Headspace Vials 90 vials

※For liquid injection, please remove HS-10 transfer line and set the AOC-20i

Switch between headspace and liquid injections with HS-Switcher for high accuracy and precision

in various applications.

f o r v e r s a t i l e c o n � g u r a t i o nHS-10 with GC-2014

f o r h i g h e s t t h r o u g h p u tHS-20 with Nexis GC-2030

With the shortest inert transfer line in the industry (30 cm), we ensure minimal carryover between different analyses.

The headspace autosampler also recognizes 10 mL and 20 mL automatically. It hence allows you to prepare

various samples without the need for adapters.

Shimadzu (Asia Pacific) Pte Ltd., February 2020Revised: April 2020

6 vials Simultaneous Heating 12 vials

225 °C Oven Temperature 300 °C

225 °C Loop Temperature 300 °C

225 °C Transfer Line Temperature 350 °C

Yes Vial Shaker Yes

No Leak Check Yes

No Barcode Reader Yes

227-36078-01

-20 to 300/320 °C

ID df 20m

0.18 mm

0.25 mm

0.32 mm

0.53 mm

1.00 µm

1.40 µm

1.80 µm

3.00 µm

Temp. Range

-20 to 300/320 °C

-20 to 300/320 °C

-20 to 280/300 °C

227-36075-01

30m

221-75962-30

227-36077-01

227-36078-02

60m

227-36078-03

75m

227-36078-04

105m

227-36076-01

221-75963-60

–

–

–

– – – –

– –

– –

Shimadzu GC column (SH-Rxi™-624Sil MS)

Disinfectants and Personal Protective Equipment (PPE)

Mask | Material Testing Based on Tensile Strength

Apart from measurements using GC and FTIR, the quality and durability of mask can be evaluatedbased on the tensile strength measurement. There are several guidelines available for thesemeasurements. Shimadzu has a range of precise universal tensile testers for all your material testingapplications.

EZ Test

AGX-V

High Precision Universal / Tensile Tester• Strength testing of protective clothing

(ISO9073-4, ASTM D5733, ISO13934-1, JIS T8115)

Compact Table-Top Universal / Tensile Tester• Mask string strength evaluation (JIS T8151)• Fabric strength, tension, tearing, puncture, and suture(ISO9073-4, ASTM D5733, ISO13934-1, JIS T8115)• Glove strength evaluation

Drug Analysis& Research

Drug Candidate Analysis

Medical researchers are racing against time to develop new drugs and treatments for COVID-19. Theyare also investigating the possibility of using existing available medicines. Some of the drug candidatesinclude hydroxychloroquine and ivermectin.

Apart from studying the efficacy of these drugs towards COVID-19, the quality of drugs is as crucial.Quality with reliable operations and high productivity can be achieved during this period throughShimadzu analytical instruments and informatics solutions..

i-Series Plus

Most robust platform to meet high pressing quality needs ofassay and related impurity methods as per pharmacopoeia

innovative Advanced interactive design

intuitive Easy operation

Intelligent Smart features for high productivity

• Low helium gas consumption ensures long unattended

operations for maximum throughput• Minimal carryover with super short headspace transfer

line

Nexis GC-2030Together with headspace HS-20, this simple setup is the optimal platform for residual solvent analysis based on USP-467.

Shimadzu Middle East & Africa

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