APPLICATION Instructionsno.1 /08

APPLICATION INSTRUCTIONSNo.1 /08

for ETOKSAMIN Disinfectant

Manufacturer: Ufa-Agrokhim LLC, Russia

AGREEDAPPROVED

Director of ROSPOTREBNADZORDirector of Ufa-Agrokhim LLC

FGUN NIID

Academician of RAMS

(signature) I.G.Shandala(signature) V.V. Suvorova

7.06.200825.06.2008

SEAL: [unreadable]SEAL: Republic of Bashkortostan, Ufa*

Limited Liability Company*UFA-AGROKHIM*

INN 0275039186

Moscow

2008

APPLICATIONINSTRUCTIONSNo.1 /08

for ETOKSAMIN Disinfectant

Manufacturer: Ufa-Agrokhim LLC, Russia

Developed in ROSPOTREBNADZOR Research Institute of Disinfectology, Federal Budgetary Institution of Science (GRUN NIID)

Authors: FedorovaL.S., LevchukN.N., PanteleevaL.G., RysinaT.Z. (FGUNNIID); GolovkinG.V. (PESTITSIDTEST CENTRE, Chapter 1Л., 8)

GENERAL INFORMATION

1.1Thereagentisalightyellow/brownliquid, with some tan-tint sediment allowable.

Etoksaminisa technical-gradeproductresulting from the reaction between monoethanolamine and formaldehyde in the presence of catalyst. Theactive substance,1,3,5-triazine-1,3,5-(2Н,4Н,6Н)-triethanol, constitutes 48-52%. Besides, the reagentalso contains the following compounding ingredients: 2-dimethylaminoethanol, dimethoxymethane, 2-butanone, methylpropyl ether, 1,3-dimethoxy-2-propanole, N,N-diethyl-1,2-ethandiamine and water, up to 100%.

Thereagentdensityat20°С is 1.050 – 1.100g/cm3. The kinematicviscosityat20°С,is 3.05 – 7.25 mm2/s.

The reagent has the shelf life of 3 years in the unopened manufacturer’s package, while the shelf life of the working solutions is 14 days.

Thereagentisavailable inthe25 to 200 dm3metal containers.

1.2Thereagentexhibits anantimicrobialactiontowardsgram-negative and gram-positive bacteria (including M. tuberculosis), viruses, Candida species of fungi, and Trichophyton. Thereagentretains its properties onfreezingandsubsequent thawing.

1.3 According toGOST 12.1.007-76, thereagentis allocatedby its acutetoxicityparameters to the category of moderatelyhazardous substances,ifswallowed(Class 3),andslightly hazardous substances,ifincontactwithskin (Class 4). According to K.K. Sidorov’s classification,it is slightly toxic,if swallowed(Toxicity Class 4); according to the classification of vapour inhalation toxicity by the degree of volatility, it is moderately harmful (HazardClass 3), exerts no local irritant action on single skin exposure, andcauses moderate eye irritation; no sensitizing action is revealed.

The reagent working solutions have a weak local irritant action on skin and eyes. Whenactuallyappliedassprays, theyare allocatedtoHazard Class 2 by the degree of the disinfectant inhalation hazard; by the subacute toxicity zone,vapours of the 1% solution are classified as slightly hazardous substances and possess no sensitizing effect.

Etoksaminairborneconcentration in the workarea is controlled by the vapours of2-dimethylethanolaminewith MPC of5 mg/m3; the substance is labelled as follows:‘Special skin and eye protection is required’.

1.4 The reagentisintendedfor the treatment ofindoor surfaces, hardfurniture, sanitaryappliances, externalsurfacesofdevicesandapparatuses, laboratoryvessels, medicalarticles(includingsurgicalanddentalinstrumentsofmetal, rubber, plasticsandglass), patientcareitems, cleaningimplements, rubbermats, medicalwasteofGroupsBandC (cottonpellets, dressing, reusablemedicalgoods, etc.) andotherwasteproducts(gowns, caps, wipers, instruments and other disposable items), footwear (of rubber, plastics and other polymer materials) in the event of infections of bacterial (including tuberculosis), viral and fungal(candidiasis, dermatophytosis) etiology when performingpreventive, current and terminal disinfection in medico-prophylactic institutions orclinical, microbiological and other laboratories, in medical transport or in foci of infection; when performing preventive disinfection of the garbage disposal systems (garbage equipment andfacilities, garbage collectors and trucks, etc.), food grade vehicles, public service establishments (public lavatories, utility rooms of hotels and hostels, barber’s/ hairdresser’s, massage and beauty salons, solariums, saunas, baths, laundries, public catering and retail establishments, industrial markets), social maintenance and penal institutions; and also when performinggeneral cleaning.

WORKING SOLUTION PREPARATION

2.1 Thereagentworkingsolutionsarepreparedintheenamel (without cracking or chipping), glassorplasticcontainersby theadditionof theproper amount of the reagent to the room-temperature drinking water (Table 1).

Table 1 – Preparation of the Reagent Working Solutions

Workingsolutionconcentration (%) by:
по: / Reagent andwateramount (mL) requiredtoprepare:
reagent / active substance (AS) / 1 L of the solution / 10L of the solution
Reagent / Water / Reagent / Water
4.0 / 2.0 / 40.0 / 960.0 / 400.0 / 9600.0
6.0 / 3.0 / 60.0 / 940.0 / 600.00 / 9400.0
8.0 / 4.0 / 80.0 / 920.0 / 800.00 / 9200.0
10.0 / 5.0 / 100.0 / 900.0 / 1000.0 / 9000.0
12.0 / 6.0 / 120.0 / 880.0 / 1200.0 / 8800.0
16.0 / 8.0 / 160.0 / 840.0 / 1600.0 / 84000
20.0 / 10.0 / 200.0 / 800.0 / 2000.0 / 8000.0
24.0 / 12.0 / 240.0 / 760.0 / 2400.0 / 7600.0
30.0 / 15.0 / 300.0 / 700.0 / 3000.0 / 7000.0

REAGENT USE FOR OBJECT DISINFECTION

3.1 Thereagentsolutionsareusedto disinfect indoor surfaces (floor, walls, doors, etc.), hardfurniture, externalsurfacesofdevicesandapparatuses, patient careitems (hotwaterbags, rectaltubes, drawsheets, etc.), medical articles (of metal, rubber, plastics, and glass), laboratory vessels(including those of single use, such as vials, pipettes, slides, cover glasses, cylinders, flasks, bottles, Petri dishes, immunoassay plates, etc.), rubber mats, cleaning implements (rags, etc.), medical (used wipers, dressing, cotton pellets) and other waste (gowns, caps, wipers, instruments and other disposable items), footwear of rubber, plastics and other polymer materials, as well as sanitary appliances (baths, sinks, toilet bowls, etc.).

3.2 Objects aredisinfectedbywiping, irrigation, immersion and soaking. Containers with working solutions for disinfection of patientcare items, medical articles and cleaning material should be tightly capped.

3.3 The indoor surfaces, hard furniture, and the surfaces of devices and apparatuses are wiped with rags impregnated with the reagent solution at the application rate of 150 mL/m2 of the treated surface or irrigated at 300mL/m2 whenusing hydraulic sprayer orautomax, or at 150mL/m2 when using the Quazar atomizer.

3.4 Thesanitaryappliancesarecleanedwithabrush or a bottle brush, or wiped with rags impregnated with the disinfectant solution atthe application rate of 150mL/m2 of the treated surface or irrigated at 300mL/m2 whenusing the hydraulic sprayer or at 150mL/m2 when using the Quazaratomizer. Aftercompletion of the disinfection, the sanitary appliances are washed with water.

Rubber mats are wiped with rags impregnated with the reagent working solution or fully immersed into the disinfectant solution. After completion of the disinfection, they are washed with running water.

3.5 Patientcareitemsarefullyimmersedinto the container with the reagent working solution or wiped with rags, impregnated with a disinfectant solution. After completion of the disinfection, they are washed with running water.

3.6 Medicalarticlesaredisinfectedinenamel(without cracking or chipping) or tightly capped plastic containers.

Medicalarticlesarefullyimmersedinto the reagent working solution. Detachable articlesare immersed into the solution disassembled.

Articleswithlockingpartsareimmersedunlockedand some preliminarylabour movements are made in the solution for its better penetration into the hard-to-get-to parts. Throughout thedisinfectantcontacttime, channels and cavities should be filled (without any air blocks) with the reagent solution. Thesolutionlayerdepthshould be atleast 1 cm.

Aftercompletion of the treatment, instrumentsareremovedfromthecontainerwiththesolutionandwashedofftheresidualreagentintherunningwaterfor 5 minutes, with specialattentionpaidtorinsingthechannels (with using a syringe or any other device) to preventwater ingress into the container with the instruments under washing.

3.7 Laboratoryvessels, includingthoseof single use, arefullyimmersedinto the reagent working solution; after thedisinfectant contact time elapses, theyarewashedwithrunningdrinking water, while the single-use vessels are disposed.

3.8 Footwearofrubber, plasticsandotherpolymer materials is immersedinto the reagent working solution. After thedisinfectant contact time elapses, the footweariswashedwithwaterand dried.

3.9 Cleaningimplementsaresoaked in the container with the reagent working solution. After the disinfectant contact time elapses, they are rinsed and dried.

3.10 MedicalwasteofGroupsBandC (useddressing, wipers, cottonpellets, etc.)aretreated withthe 8.0%, 10.0%, 12.0% and 15.0% reagent solutions, the contact time being360, 240, 180 and 120 minutes, respectively, while medical single-use articlesare disinfected with the 6.0%, 8.0%, and 10.0% reagent solutions, the contact time being 240, 120 and 90 minutes.

Thetreatmenttechnologyforsingle-usemedicalarticlesis similar to that for reusable articles and is specified in p.3.6. After completion of the disinfection, waste and articles are disposed.

3.11 The medicaltransportisdisinfectedfollowingtransportation of contagious patients according to the appropriate infection mode.

Preventive disinfection of the medical transport and food grade vehicles is performed by the modes outlined in Table 3.

The disinfection modes for medical articles and various objects in medico-prophylactic institutions are given in Tables 2-9.

The modes for general cleaninginmedico-prophylacticinstitutionsaregiveninTable 10.

3.12 When performing general cleaningandpreventivedisinfectioninthepublicserviceestablishments (publiclavatories, utility rooms in hotels and hostels, public catering and retail establishments, and industrial markets), in food grade vehicles, as well as in social maintenance and penal institutions,the reagent is used by the modes listed in Table 9.

The treatment modes used for preventivedisinfectionofthegarbagedisposalsystems (garbage equipment and facilities, garbage collectors and trucks, etc.) are given in Table 9.

Duringpreventivedisinfectionintheutilityroomsofbarber’s/ hairdresser’s, massage and beauty salons, solariums, saunas, baths, laundries, etc. the reagent is used by the modes given in Table 10.

Table 2 – Modes of Medical Goods DisinfectionwithETOKSAMINSolutions

Type of articles under treatment / Type of infection / Treatment modes / Treatment method
Concentration, % (by AS) / Disinfectant contact time, min.
Medicalarticles(includingsurgicalanddentalinstruments) made of metal, rubber, plastics and glass / Viral and bacterial (except tuberculosis) / 4.0 / 60 / Immersing
Viral, bacterial (including tuberculosis) and fungal (candidiasis, dermatophytosis) / 6.0 / 240
8.0 / 120
10.0 / 90

Table 3 – Modes of Object DisinfectionwithETOKSAMINSolutions in Bacterial (Except Tuberculosis) Infections

Table 5 – Modes of Object DisinfectionwithETOKSAMINSolutions in Candidiasis

Table6 – Modes of Object DisinfectionwithETOKSAMINSolutions in Dermatophytosis

Disinfection objects / Working solution concentration, % (by AS) / Disinfectant contact time,
min. / Method of disinfection
Indoorsurfaces, hardfurniture, external surfaces of devices and apparatuses, medical transport / 6.0 / 240 / Wiping or irrigation
8.0 / 120
10.0 / 90
Laboratoryvessels (including those disposable) / 2.0 / 180 / Immersing
3.0 / 90
4.0 / 30
Cleaning facilities / 5.0 / 240 / Soaking
6.0 / 180
8.0 / 120
10.0 / 90
Patientcareitemsmadeofmetal, rubber, plasticsandglass / 2.0 / 240 / Wiping or immersing
3.0 / 120
4.0 / 60
Disinfection objects / Working solution concentration, % (by AS) / Disinfectant
contact time,
min. / Method of disinfection
Indoorsurfaces, hardfurniture, external surfaces of devices and apparatuses, medical transport / 5.0
6.0
8.0
10.0 / 360
180
120
90 / Wiping or irrigation
Sanitary appliances / 5.0
6.0
8.0
10.0 / 360
180
120
90 / Doublewipingordoubleirrigationat a 15 minute interval
Laboratoryvessels (including those disposable) / 6.0
8.0
10.0 / 120
90
60 / Immersing
Cleaning facilities / 6.0
8.0
10.0
12.0 / 360
240
120
90 / Soaking
Patient careitems / 5.0 / 180 / Doublewipingat a 15 minute interval
6.0 / 120
8.0 / 90
10.0 / 60 / Immersing or wiping

Table4 – Modes of Object DisinfectionwithETOKSAMINSolutions in Tuberculosis

Disinfection objects / Working solution concentration, % (by AS) / Disinfectant contact time,
min. / Method of disinfection
Sanitary appliances / 6.0
8.0
10.0
4.0 / 240
120
90
30 / Double wiping or double irrigation at a 15 minute interval
Cleaning implements / 8.0
10.0
12.0
15.0 / 300
180
120
60 / Soaking
Laboratoryvessels (including those disposable) / 6.0
8.0
10.0 / 180
90
60 / Immersing
Bathsandals, slippers, etc. madeofrubber, plasticsandothersyntheticmaterials / 6.0
8.0
10.0 / 120
90
60 / Immersing
Rubber mats / 6.0
8.0
10.0
12.0
6.0
8.0
10.0 / 240
120
90
60
90
60
30 / Immersing or wiping
Double wiping at a 15 min. interval
Patient care items / 8.0
10.0
12.0
6.0 / 120
90
60
120 / Immersing or wiping
Double wiping at a 15 min. interval

Table6 – Modes of Object DisinfectionwithETOKSAMINSolutions in ViralInfections (Poliomyelitis, CoxsackieandECHO; Enteral and Parenteral Hepatitis, HIV-Infections; Influenza, H5NI Bird Flu, and Other ARVI; Herpetic, Cytomegalovirus, Adenovirus, etc.)

Table 8 – Modes of Object DisinfectionwithETOKSAMINSolutions during General Cleaning

inMedico-Prophylactic Institutions

Premises and profile of the institution (department) / Working solution concentration, % (by AS) / Disinfectant contact time, min. / Method of disinfection
Surgeryunits; dressing, treatmentandmanipulationrooms; clinicallaboratories; autoclaveroomsinsurgery, gynecology, urologyanddentalunitsandin-patient departments; delivery rooms of maternity obstetric hospitals / 4.0 / 60 / Wiping or irrigation
5.0 / 30
Treatmentsections, functionaldiagnosticsandphysiotherapeuticrooms, etc. inmedico-prophylacticinstitutionsof any profile (except infectious) / 2.0 / 360 / Wipingorirrigation
3.0 / 180
4.0 / 90
Infectiousdiseasesmedico-prophylacticinstitutions / According to the appropriate infection mode
TB medico-prophylacticinstitutions / 5.0 / 360 / Wiping or irrigation
6.0 / 180
8.0 / 120
10.0 / 90
Dermatovenerologicmedico-prophylacticinstitutions / 6.0 / 240 / Wiping or irrigation
8.0 / 120
10.0 / 90

Table9 – Modes of DisinfectionwithETOKSAMINSolutions for Various Objects (PublicLavatories, UtilityRoomsinHotels and Hostels, IndustrialMarkets, Social Maintenance and Penal Institutions, Food Grade Vehicles, etc.)

Disinfection objects / Working solution concentration, % (by AS) / Disinfectant contact time, min. / Method of disinfection
Indoorsurfaces, hardfurniture, external surfaces of devices and apparatuses / 2.0 / 360 / Wiping
3.0 / 180
4.0 / 90
Sanitary appliances / 2.0 / 360 / Doublewipingat a 15 minute interval
3.0 / 180
4.0 / 90
Cleaning
implements / 5.0 / 240 / Soaking
6.0 / 180
8.0 / 120
10.0 / 90
Patientcareitems / 2.0 / 360 / Wiping or immersing
3.0 / 120
4.0 / 60

Table10 – Modes of DisinfectionwithETOKSAMINSolutions for Various Objects (Barber’s/ Hairdresser’s, Baths, SwimmingPools, MassageandBeautySalons, Sanitary Inspection Rooms, etc.)

Disinfection objects / Working solution concentration, % (by AS) / Disinfectant contact time, min. / Method of disinfection
Indoorsurfaces, hardfurniture, external surfaces of devices and apparatuses / 6.0 / 240 / Wiping
8.0 / 120
10.0 / 90
Sanitary appliances / 6.0 / 240 / Doublewipingat a 15 minute interval
8.0 / 120
10.0 / 90
Cleaning implements / 8.0 / 300 / Soaking
10.0 / 180
12.0 / 120
15.0 / 60
Instrumentsmadeofmetal, rubber, plastics and glass / 6.0 / 180 / Immersing
8.0 / 90
10.0 / 60
Bathsandals, slippers, etc. madeofrubber, plasticsandothersyntheticmaterials / 6.0 / 120 / Immersing
8.0 / 90
10.0 / 60
Rubber mats / 6.0 / 240 / Immersing or wiping
8.0 / 120
10.0 / 90
12.0 / 60
6.0 / 90 / Doublewipingat a 15 minute interval
8.0 / 60
10.0 / 30
Patientcareitems / 6.0 / 120 / Doublewiping at a 15 minute interval
8.0 / 90 / Immersing or wiping
10.0 / 60
12.0 / 60
Waste (single-use articles – instruments, gowns, caps, linen, cotton pellets, wipers, etc.) / 8.0
10.0
12.0
15.0 / 300
180
120
60 / Immersing

SAFETY PRECAUTIONS

5.1 Whenpreparingworkingsolutions,wear rubber gloves to protect hands and goggles to protect eyes;when treating objects, wearrubber gloves to protect hands.

5.2 Avoidcontactofthereagentandworkingsolutionswith skin and eyes.

5.3 Donotallowpersonswith hypersensitivitytochemicalsubstancesandchronicallergic diseases to handle the reagent.

5.4Surfacewiping witha1.0% workingsolutioncan be performed with patients present. Otherworkingsolutionsare used without patients, and the room is aired until the odourdisappears.

5.5Whenirrigatingsurfaces,personalprotectiveequipmentshould be used, namely: the universal RU-60M or RPG-67 respirators of a cartridge type В- for respiratory system, goggles - for eyes, and rubber gloves – for hands. Aftercompletion of the irrigation disinfection,wet cleaning and aeration are recommended.

5.6 Whenperformingdisinfection,itisnecessarytofollow the standard personal hygiene precautions. Once the work has been completed, open body parts (face, hands) should be washed with water and soap.

FIRST AID MEASURES

6.1Disregard forsafety precautions whenhandlingthereagentmaycauseirritationofupperairways, eyes and skin.

6.2If signs of respiratory irritation appear, stop handling reagent,movethevictimtofreshairorothercleanarea, andairtheroom. Rinse the mouth and nasopharynx with water. Seek medical advice if required.

6.3In case of ingestion, let the victim drink (if the person is conscious) severalglassesofwaterandinducevomiting; thenlet him/her drink 1-2 glassesofwaterwith10-20 powderedtabletsofactivecarbon; seek medical advice if required.

6.4Incaseofeyecontact, immediately rinse eyes with plenty of water for 10-15 minutes, instill 30% solution of sodium sulfacyl and seek medical advice if required.

6.5Incaseofskincontact,immediatelywashtheskinwithplentyof water and apply some emollient cream.

TRANSPORTATION, STORAGE

7.1Thereagentistransportedbyallavailablemeansoftransport (atatemperatureof nolessthan - 20°Сand no more than + 35°С), operating on the territory of Russia and ensuringsafety of the product and package.

7.2Store thereagentinwell-ventilated areasatatemperatureof nolessthan0°Сand no more than + 35°С, separately from medicines and food, and out of reach of children.

7.3Absorb thespillwithnon-combustible substances (sand, cuttings, rags, silica gel) and send for disposal. Solutions may be discharged into the sewers only when diluted.

Whilehandlingthespills, wear protectiveclothing, rubberapron, rubber boots, as well as personal protective equipment, namely: rubber gloves, goggles and universal RU-60M or RPG-67 respirators of a cartridge type В.

7.4Environmentalprotection: avoidthe undiluted product runoff to the sewage/surface or ground waters and sewers. The reagent may be discharged into sewers only when diluted.

ANALYTICAL METHODS FOR REAGENT QUALITY PARAMETERS

Thereagentshouldcomplywiththefollowingqualityparametersand specifications in Table 11.

Table 11–Reagent Parameters and Specifications

Parameter / Specifications

Appearance

/ Liquidoflightbrowntobrowncolour. Sometan-tintsedimentisallowable.

Density at 20 С0, g/cm3

/ 1.050 – 1.100

Kinematicviscosityat20 С0, mm2/s (cSt)

/ 3.05 – 7.25

Etoksamincontent, %

/ 48 - 52

8.1DeterminationofAppearance

Thesubstanceappearanceisdeterminedbyviewing about25 - 30 mLofasampleinacolourless-glassbeakeragainst the background of a white sheet of paper in transmitted or reflected light.

8.2Determination of Density

The substance density at 20 °Сis determined with using eitherareometer or pyknometer.

8.3 Viscosity Determination

Thekinematicviscosityat 20 °Сis determined with usingviscometer.

8.4 Etoksamin Content Determination

The Etoksamin content in the reagent is determined by the method of the reversed-phase high-performance liquid chromatography (RP HPLC) with using a UV detector, isocratic chromatography mode and absolute calibration.

8.4.1 Equipment, Reagents, Solutions

Knauer analytical liquid chromatograph with a UV detector, or equivalent

Injector with a 20μL metering loop

UltrasphereODSreversed-phase sorbent column(250 mmx 4.6mm) with 5μm particle size or any other of similar separating capacity

ShimatzuC-R3A integrator or similar integrating device

Hamilton 100 μL micro-syringe for a liquid chromatograph.

General-purposeanalyticalbalanceofClass 2 accuracywith the capacity of 200g

USbathormechanical stirrer

Cylinders of 50- and 1000-mL volume

50 mL volumetricflasks

0Э5-mLpipet

Etoksaminisananalyticalstandardoratechnical-gradeproductwith a fixed content of the basic substance (no less than 96 %).

Very-high-purity acetonitrile for HPLC

Chemicallypureo-phosphoric acid; water solution with mass fraction of 0.2 %.

Deionizedandbidistilledwater

Paper or 0.4 – 0.5 μmporous membrane filter

8.4.2Preparing for Analysis

8.4.2.1 Preparation of the mobile phase (eluent): mix acetonitrile and o-phosphoric acid solution at 60:40volume ratio. Prior to use, the eluent is degassed with using a US bath or any other means available.

8.4.2.2 Columnconditioning: theeluentispumped through the column at a rate of 1 mL/min. for 20-30 minutes until the stable baseline is obtained.

After completion of the work, the column is washedby pumping the degassed mixture of acetonitrile and water (5:1 by volume).

8.4.2.3 Chromatographic Conditions

The chromatograph is put into operation according to the device operating instruction. Thecalibrationmixtureandanalyteare chromatographed under the following conditions:

Columntemperature:ambient(20 ~ 25 °С)

Eluent:acetonitrile – 0.2 % solution of o-phosphoric acid (60 : 40 by volume)

Eluentflowrate:1.0 mL/min

Wavelength:254 nm

Sensitivity:0.1 AUFS

Injection volume:20 μL

Approximate Etoksamin retention time: 4.5 – 5.5 min

To attain effective separation of the sample components, chromatographicconditionsmaybechangedaccording to the chromatograph design and column separating capacities.

8.4.2.4 Preparation of the Calibration Mixture

Weigh, to the nearest fourth decimal place, about 0.01g of Etoksamin as the analytical standard to a 50mL volumetric flask, add 35-40 mL of acetonitrile and dissolve with using a US bath or stirrer, thenmake up to the mark with acetonitrile and mix thoroughly. Prepare two such sets of calibration solutions. Each calibration mixture is injected into the chromatograph. Etoksamin retention time and peak area in the calibration mixture is determined fromatleasttwochromatogramsobtained.

Etoksamin peak areas in parallel injections for each calibration solution should not differ by more than 1 %. In case the difference is greater, additional injection of the calibration solution is performed.

Calibrationsolutionscanbekept over a dayintightly-stoppered flasks inthefridge.

The K calibration factor for Etoksaminis calculated by the formula:

K = S.100/m.a

whereS–Etoksamin peak area in the calibration solution;

m–mass of Etoksamin analytical standard in the calibration solution;

а–basic substance content of theEtoksamin analytical standard, %.

The results are rounded to the second decimal place.

An arithmetical mean of all determination results is taken as Etoksamin calibration factor, the differences should not exceed 0.02.

8.4.3 Analysis Performance

Weigh, tothenearestfourthdecimalplace, about 0.02gofthereagenttothe 50mLvolumetricflask, add 35 40 mL of acetonitrile and dissolve with using a US bath or stirrer, then make up to the mark with acetonitrile and mix thoroughly. Filterifrequiredandinjectintothechromatograph. The chromatograms obtained are used for determining Etoksamin peak area in the analyte.

8.4.4. Results Processing

Etoksamin content (X, %) in the reagent is calculated by the formula:

Х- S=100/K.m

whereS - Etoksaminpeakareaintheanalyte;

К - calibration factor;

m–reagent mass taken for analysis, g.

Anarithmeticalmeanoftwoparallelmeasurementsistakento be theresultofmeasurements,the absolute difference between them does not not exceed the allowable difference equal to 2 %.