en do toxin catalog

1-800-638-8174www.cambrex.com/LALRevised 7-04CAT-LAL-1, 07/04

Endotoxin DetectionProducts

History of Endotoxin Detection ..........................................................3

About Cambrex..................................................................................4

Gel Clot Assays .................................................................................5

Kinetic Assays....................................................................................9

PyroGene® Recombinant Factor C Assay........................................11

Chromogenic End-Point Assays ......................................................12

Instrumentation and Software..........................................................13

Accessory Products .........................................................................15

Testing Services...............................................................................16

Testing Services – Pre-Paid Europe Only .......................................17

PRODUCTSPyroGene® Recombinant Factor C Assay........................................11

FLx800™ Fluorescent Microplate Reader.........................................13

PyroTherm Pyrogen Monitoring System..........................................13

WinKQCL® Software V 3.00.............................................................14

Eppendorf BioPur® Pipette Tips .......................................................15

Stepped Neutral Density Plate ........................................................15

Products manufactured by Cambrex Bio Science Walkersville, Inc.

1-800-638-8174www.cambrex.com/LAL

2

Endotoxin Detection

NEW

Ever since the pharmaceutical industry beganmanufacturing injectables, pyrogen detection testshave been an absolute necessity. Pyrogens aresubstances that can cause fever, shock and evendeath if high levels are introduced into a person’s body.

For most of the 20th Century, the Rabbit Pyrogen Testwas the standard method of testing for pyrogenicity.This test, which takes approximately four hours, isaccomplished by injecting the drug being analyzedinto a rabbit’s ear. If the animal develops a fever, itconfirms the presence of pyrogens.

The Limulus Amebocyte Lysate (LAL) test wascommercially introduced during the 1970’s. In a noticepublished in the Federal Register on November 4, 1977,the FDA described conditions for the use of LAL as anend-product test for endotoxin in human biologicalproducts and medical devices. The FDA noted, it iswidely recognized that the LAL test is faster, moreeconomical and requires a smaller volume of productthan does the rabbit pyrogen test. In addition, theprocedure is less labor intensive than the rabbit test,making it possible to perform many tests in a single day.

To obtain the lysate required for the LAL test,horseshoe crabs are taken from the ocean floor anda small amount of their blood is drawn. The animals

are then returned unharmed to the sea. Next, thecrabs’ blood cells (amebocytes) are separated andlysed to obtain the cellular proteins.

As LAL became the preferred pyrogen detection test, different methods were developed, each with its own unique benefits. For example, Gel Clot LAL(PYROGENT®) provides a simple positive/negativeresult and is often mentioned in most pharmacopoeialmonographs as the official referee test. ChromogenicEnd-Point LAL (QCL-1000®) offers a quantitative result and exhibits less product interference than LAL methods utilizing the clotting protein. KineticTurbidimetric (PYROGENT®-5000) gives quantitativeresults and for water and large volume parenterals, itoffers an economical choice. Kinetic ChromogenicLAL (Kinetic-QCL®) provides automation and greatersensitivity detecting as low as 0.005 EU/mL.

Currently the FDA, the United States Pharmacopoeia(USP), the European Pharmacopoeia (EP) and theJapanese Pharmacopoeia (JP) accept all of theabove LAL methods, as do most individual countrypharmacopoeias.

The latest development in endotoxin detectiontechnology is PyroGene®. This innovative product isa recombinant form of Factor C, the first componentin the Limulus clotting cascade. PyroGene promisesto reduce the dependence on animal-basedendotoxin assays.


3

From Rabbits to Horseshoe Crabs, a Brief History of Endotoxin Detection

Cambrex Bio Science Walkersville, Inc. is theindustry leader in sales and innovations for endotoxindetection products, services and software. First tocommercialize quantitative chromogenic LAL… first to use polynomial regression… first to develop arecombinant endotoxin-activated detection method…first to use fluorescence in an endotoxin activationassay… first on-line endotoxin detection method forWFI… first in quality… first in compliance… first incustomer relations. At Cambrex, we are focused on your endotoxin testing requirements – now and inthe future.

Sales & Customer ServiceOur customer service department is filled withtenacious problem solvers who are pleased to find the answers to your questions and to assist you withyour order.

Cambrex Bio Science Walkersville, Inc.8830 Biggs Ford Road • Walkersville, MD 21793 (888) 403-8772 or (301) 898-7025 Fax: (301) 845-8708 for domestic orders and (301) 845-8291 for international orders.www.cambrex.com • [email protected]

Cambrex Bio Science Verviers, S.P.R.L.32-87-32-16-11 • Fax: 32-87-35-19-67 [email protected]

Cambrex Bio Science Wokingham, Ltd. 44-118-979-5234 • Fax: 44-118-979-5231 [email protected]

Cambrex Bio Science Milano, S.P.R.L. 39-0363-35-14-70 • Fax: 39-0363-35-14-75

Cambrex Bio Ciencia Brasil Ltda. 55-11-5180-3677 • Fax: 55-11-5180-3648

Cambrex Chemicals Pvt. Ltd. (India) 91-22-5697-2883/84/85 • Fax: [email protected]

Technical ServiceCambrex endotoxin detection expertise is just a phonecall away. Our dedicated technical specialists arealways ready to answer your endotoxin testing-relatedquestions. For assistance in your lab, our technicalsales force is available through a world-wide network.Workshops are conducted throughout this network tosupply both the novice and the experienced LAL userwith answers to the most difficult challenges. With over20 years of LAL experience, Cambrex will provide youwith the best technical support in the industry.

For questions regarding the endotoxin detectionassays, please contact our Technical ServiceSpecialists.

U.S. and other non-European locations, call (800) 654-4452 or (301) 898-7025 ext. 7822or e-mail [email protected]

Fax: (301) 852-5663 for U.S. and other non-European locations

European customers can [email protected]

Or, visit our web site at www.cambrex.com/LAL


4

About Cambrex

Kinetic-QCL, QCL-1000, PYROGENT, PyroGene and WinKQCL are registeredtrademarks of Cambrex Bio Science Walkersville, Inc. ELx808, ELx808R and FLx800 aretrademarks of Bio-Tek. BioPur is a registered trademark of Eppendorf International, Inc.© 2004, Cambrex, Inc.

PYROGENT® Gel Clot LALThe PYROGENT Gel Clot Assay is a qualitative LAL test for Gram-negative bacterial endotoxin.PYROGENT is available as a lysate kit withsensitivities of 0.03, 0.06, 0.125 and 0.25 EU/mL.Standard kit sizes include 250 and 80 tests, and a 25-test kit in a single test vial format is available.These kits do not include a matched control standardendotoxin. However, the standard can be purchasedseparately (see Gel Clot Accessory Products, page 8).A Certificate of Quality is included with each kit.

STORAGE CONDITIONS• 2°C – 8°C.

ORDERING INFORMATION

PYROGENT Cat. No. Size Sensitivity EU/mL

N104 250 tests 0.03

N183-06 80 tests* 0.06

N184-06 250 tests** 0.06

N183-125 80 tests 0.125

N184-125 250 tests 0.125

N183-25 80 tests 0.25

N184-25 250 tests 0.25

*80 tests = Contains: 5 x 16 tests/vial of lysate**250 tests = Contains: 5 x 50 tests/vial of lysate

PYROGENT (Single Test Vials)Cat. No. Size Sensitivity EU/mL

N189-03 25 tests 0.03

N189-06 25 tests 0.06

N189-125 25 tests 0.125

N189-25 25 tests 0.25

Contains: 25 single test vials of lysate

PYROGENTCat. No. Size Sensitivity EU/mL

F209 50 tests 0.06, 0.125, 0.25

Contains: 1 x 50 tests/vial of lysate

Complete 20 Test KitCat. No. Size Sensitivity EU/mL

50-500U-06 20 tests 0.06

50-500U-12 20 tests 0.125

Contains: 22 single test vials5 inhibition control vials1 positive control vial1 x 5 mL vial LAL reagent water28 pipettes1 sheet of labels

Limulus Amebocyte Lysate Control KitCat. No. Size

50-510U 5 tests

Contains: 5 positive control vials5 negative control vials

Inhibition ControlCat. No. Size

50-506U 5 single test vials


5

Gel Clot Assays

PYROGENT® Plus Gel Clot LALThe PYROGENT Plus Gel Clot Assay combinesPYROGENT LAL with a matched control standardendotoxin. The Certificate of Quality documenting the FDA and USP required RSE/CSE correlation is included in each kit. PYROGENT Plus kits are available with sensitivities of 0.03, 0.06, 0.125 and 0.25EU/mL. Standard kit sizes are 200 and 64 tests. Bulkconfigurations containing 4,000 tests are also available.



PYROGENT Plus Cat. No. Size Sensitivity EU/mL

N204 200 tests 0.03

N283-06 64 tests 0.06

N284-06 200 tests 0.06

N283-125 64 tests 0.125

N284-125 200 tests 0.125

N283-25 64 tests 0.25

N284-25 200 tests 0.25

Contains: 1 x 10 ng/vial endotoxin64 Tests = Contains: 4 x 16 tests/vial of lysate200 Tests = Contains: 4 x 50 tests/vial of lysate

PYROGENT Plus Single Test VialsCat. No. Size Sensitivity EU/mL

N289-03 24 tests 0.03

N289-06 24 tests 0.06

N289-125 24 tests 0.125

N289-25 24 tests 0.25

Contains: 1 x 1 mL vial endotoxin24 single test vials of lysate


6

Gel Clot Assays

Gel Clot BulkConfigurationsBulk configurations are available for those laboratoriesusing large volumes of reagents. These configurationsare made to order, and production lead times arerequired. Please inquire for more information:


PYROGENT® Plus Bulk KitCat. No. Size Sensitivity EU/mL

N488 4,000 tests 0.03

N288-06 4,000 tests 0.06

N288-125 4,000 tests 0.125

N288-25 4,000 tests 0.25

Contains: 20 x 10 ng/vial endotoxin80 x 50 tests/vial of lysate

Bulk LysateCat. No. Size Sensitivity EU/mL

E203L 25 x 50 test/vial 0.03

E203U 100 x 50 test/vial 0.03

E209L 25 x 50 test/vial 0.06, 0.125, 0.25

E209U 100 x 50 test/vial 0.06, 0.125, 0.25

F245U 100 x 16 test/vial 0.06, 0.125, 0.25

Bulk EndotoxinCat. No. Size

7360L 25 vials, 10 ng/vial


7

Gel Clot Assays

PYROGENT® Ultra Gel Clot LALThe PYROGENT Ultra Gel Clot Assay contains aseries of convenient pre-mixed liquid endotoxinstandards at the concentrations necessary to create astandard curve. Designed to increase your productivityin the lab, these liquid endotoxin standards decreasetime, hassle and potential human error by eliminatingthe need for dilution and vortexing. A Certificate ofQuality is included with each kit.



PYROGENT UltraCat. No. Size Sensitivity EU/mL

N403 200 tests 0.03

N406 200 tests 0.06

N412 200 tests 0.125

Contains: 5 x 5 mL gel clot liquid endotoxin standards(2 λ, λ, 0.5 λ, 0.25 λ, 20 λ)4 x 50 tests/vial of lysate

Gel Clot Accessory ProductsCambrex’s Control Standard Endotoxin is referencedagainst the USP Reference Standard Endotoxinfollowing the procedures set forth in the Guidelines onValidation of the Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test for Human and AnimalParenteral Drugs, Biological Products, and MedicalDevices. Certificates of Quality showing potency areavailable upon request.



Endotoxin (E. coli)Strain O55:B5

Cat. No. Size

N185 5 vials x 2.5 mg/vial

N186 5 vials x 10 ng/vial

Endotoxin Challenge VialsCat. No. Size

N187 25 vials

Used for oven validationsE. coli endotoxin (>1,000 EU/vial)


8

Gel Clot Assays

PYROGENT®-5000Turbidimetric LALPYROGENT-5000 is a quantitative, kinetic assay forthe detection of Gram-negative bacterial endotoxin.This assay has a sensitivity range from 100 EU/mLto 0.01 EU/mL and is ideal for testing water samples,large volume parenterals, and medical devices. ThePYROGENT-5000 assay is performed in a 96-wellplate allowing for high-throughput processing. The useof an incubating plate reader is required for this assayto measure change in turbidity (see Instrumentationand Software, page 13). The sample reaction timesare then plotted against a standard curve to calculateendotoxin concentration. A Certificate of Quality isincluded in each kit.



PYROGENT-5000 Turbidimetric LALCat. No. Size Sensitivity (EU/mL)

N383 100 tests 0.01 – 100

(2 x 50 tests/vial lysate)

N384 200 tests 0.01 – 100

(2 x 100 tests/vial lysate)

Contains: Lysate2 vials reconstitution buffer1 x 50 ng/vial endotoxin

PYROGENT®-5000 Bulk ConfigurationsBulk Configurations are available for those laboratoriesusing large volumes of reagents. These configurationsare made to order, and production lead times arerequired. Please inquire for more information.


Cat. No. Description Sensitivity (EU/mL)

N588 2,250 tests 0.01 – 100

Contains:

45 x 50 tests/vial lysate

45 vials reconstitution buffer

10 x 50 ng/vial endotoxin

N688 4,500 tests 0.01 – 100

Contains:

45 x100 tests/vial lysate

45 vials reconstitution buffer



9

Kinetic Assays

Kinetic-QCL®

Chromogenic LALKinetic-QCL is a quantitative, kinetic assay for thedetection of Gram-negative bacterial endotoxin. It is the most sensitive of the LAL assays, having asensitivity range from 50 EU/mL to 0.005 EU/mL.Kinetic-QCL is ideal for testing small volumeparenterals, vaccines, antibiotics, and biologicals. This assay is performed in a 96-well plate allowing forhigh-throughput processing. The sample reactiontimes are then plotted against a standard curve tocalculate endotoxin concentration. An incubating platereader is required for this assay (see Instrumentationand Software, page 13). A Certificate of Quality isincluded in each kit.



Kinetic-QCL Chromogenic LALCat. No. Size Sensitivity (EU/mL)

50-650U 192 tests 0.005 – 50

Contains: 8 x 24 tests/vial of Kinetic-QCL lysate2 x 10 ng/vial endotoxin3 x 30 mL vials LAL reagent water

Kinetic-QCL BulkConfigurationsBulk Configurations are available for those laboratoriesusing large volumes of reagents. These configurationsare made to order, and production lead times arerequired.


Please inquire for pricing and more information.

Cat. No. Description Sensitivity (EU/mL)

K50-643L 600 tests 0.005 – 50

Contains:


K50-643U 2,400 tests 0.005 – 50

Contains:


EndotoxinCat. No. Description

E50-643L 25 x 10 ng/vial endotoxin

Lysate and EndotoxinCat. No. Description Sensitivity (EU/mL)

50-650 NV 2,040 tests 0.005 – 50

Contains:



50-650H 2,400 tests 0.005 – 50

Contains:




10

Kinetic Assays

PyroGene Recombinant Factor C Endotoxin DetectionSystem represents another first from the endotoxindetection technology leader. Our scientists haveproduced a recombinant form of Factor C, the firstcomponent in the Limulus clotting cascade activatedby endotoxin. Once again, Cambrex leads the waywith evolutionary technology that promises to reducethe dependence on animal-based endotoxin assays.

Advantages of PyroGene:• Greater endotoxin specificity • Elimination of false positive

glucan reactions • Less lot-to-lot variability • No animal utilization

PyroGene represents a reliable, environmentallyfriendly alternative to LAL. We at Cambrex invite you to experience the PyroGene alternative.

Recombinant Factor C (rFC) is activated by endotoxinbinding, and the active moiety created then acts tocleave a synthetic substrate which results in thegeneration of a fluorogenic compound. The reaction is run in a 96-well microplate and measured at timezero and after a one-hour incubation in a fluorescentmicroplate reader using excitation/emissionwavelengths of 380/440 nm. The log net fluorescenceis proportional to the log endotoxin concentration and is linear in the 0.01 – 10 EU/mL range. Lot-to-lotstandard curves exhibit excellent reproducibility.

Similar endotoxin potency is detected in purifiedlipopolysaccharides using PyroGene®, Kinetic-QCL®

and PYROGENT®-5000 assays.



PyroGene Recombinant Factor C AssayCat. No. Size Sensitivity (EU/mL)

50-658U 192 tests 0.01 – 10

For the instrumentation and software see page 13.


11

PyroGene® Recombinant Factor C Assay

Figure 1: rFC Endotoxin Standard CurvesUsing 4 Different Lots of rFC

Figure 2: The rFC Assay and LAL Assays Measure Similar Endotoxin Potency in Purified LPS

NEW

QCL-1000® Chromogenic End-Point LALQCL-1000, the most rapid of the LAL tests, is a 16 minute, quantitative endpoint assay that has asensitivity range from 1.0 EU/mL to 0.1 EU/mL. This chromogenic assay forms a yellow color and ismeasured photometrically at 405 – 410 nm. WithQCL-1000, a multichannel pipette and a 96-well plate,you can run 96 reaction wells at one time. This assaycan also be run in tubes. A Certificate of Quality isincluded in each kit.



QCL-1000 Chromogenic End-Point LALCat. No. Size Sensitivity (EU/mL)

50-647U 120 tests 0.1 – 1.0

Contains:

5 x 1.4 mL lysate

1 x 1 mL vial endotoxin

2 x 30 mL vials LAL Reagent Water

2 x 6.5 mL chromogenic substrate

50-648U 300 tests 0.1 – 1.0

Contains:

5 x 3 mL lysate

2 x 1 mL vial endotoxin

5 x 6.5 mL chromogenic substrate

QCL-1000® AccessoryProductsEndotoxinStrain 0111:B4

Cat. No. Size

E50-640 1 x 1 mL vial endotoxinApproximately 15 – 40 EU/mL


12

Chromogenic End-Point Assays

Standard Kinetic System This system comes complete with all of the hardwareand software needed to run the kinetic quantitative LAL assays.

Cat. No. 25-335

Includes: Dell computer with Pentium IV Microprocessor

Software: Windows 2000®, WinKQCL®

softwareFlat Panel 15.0 inch viewable monitorHP laserjet® 1300 (or equivalent)Bio-Tek® ELx808™ incubating 96-well

plate readerStepped neutral density plate

Bio-Tek® ELx808™ IncubatingReader Cat. No. 25-315

UV-Vis filter spectrophotometer for reading andincubation of 96-well microplates. Works withWinKQCL Software.

FLx800™ Fluorescent MicroplateReader with Ex/Em 380/440 Cat. No. 25-344

UV-Vis filter fluorometer for reading and incubation of 96-well microplates. Works with WinKQCL®

Software V 3.00.

High Throughput SystemRobotic workstations to completely automate LALtesting are available and can be tailored to your needs.

PyroTherm Pyrogen Monitoring SystemPyroTherm is a computer integrated, high performance,programmable heat block. This equipment is designedfor a broad range of temperatures, from 5°C – 300°C,but has been optimized for the LAL gel clot test.PyroGel software is a 21 CFR Part 11 compliantsoftware package designed to work with the PyroThermunit. The software offers temperature profiling duringan assay, as well as integrated sample managementwith sample tracking and automatic calculation andreporting. In addition, depyrogenation of test tubes canbe done using the heat block.

Cat. No. 25-347


13

Instrumentation and Software

NEW

NEW

WinKQCL® Software V 2.00 WinKQCL is the industry leading software applicationdesigned to manage, analyze, and report kinetic LALassay data. It features compliance with 21 CFR Part11 for electronic records and signatures, providesefficiency with a trending database, validation support,and bar code reading.

Cat. No. 25-301

IQ/OQ/PQ Manual for V 2.00 Installation, operational, and performance qualificationmanual for documented installation of the system.

Cat. No. 25-338M

Validation Manual for V 2.00 This notebook features over 500 documented testcases used to validate the software.

Cat. No. 25-341

System Qualification Service A trained specialist from Cambrex performs theinstallation, operation, and performance qualification ofthe Kinetic System.

Cat. No. 25-339S

IQ/OQ/PQ Manual for PyroGene®

Cat. No. 25-354

WinKQCL® Software V 3.00 Our newest version of WinKQCL continues to becompliant with 21 CFR Part 11 regulations. We havebuilt in the ability to share databases over a network in a client/server interface. Test results can now beexported to a LIMS database. The software will alsosupport our new PyroGene® assay and will interfacewith the FLx800™ Reader.

Client/Server Version Cat. No. 25-348

Additional Software License (required for multiple workstations)

Cat. No. 25-353

IQ/OQ/PQ Manual for Kinetic LALSystem WinKQCL V 3.00 Cat. No. 25-349

Validation Manual for WinKQCL V 3.00 Cat. No. 25-350


14

Instrumentation and Software

NEW

Assay Plate

TemplateManager


15

Accessory Products

LAL Accessory ProductsReagentsName Cat. No. Size Storage Conditions Comments

ß-G-Blocker N190 5 x 5 mL vials 2°C – 8°C Used to block glucaninterference

Pyrosperse N188 5 x 5 mL vials 2°C – 30°C Dispersing agent

MgCl2 S50-641 30 mL vial 2°C – 30°C 10 mM Solution

Tris Buffer S50-642 30 mL vial 2°C – 30°C 50 mM Solution

LAL Reagent W50-640 30 mL 2°C – 8°C <0.005 EU/mLWater W50-100 100 mL 15°C – 30°C

W50-500 500 mL 15°C – 30°C

LabwareName Cat. No. Size Quantity Comments

Pyrogen-free N201 10 x 75 mm 50/pkg W/polypropylene screw caps Test Tubes

Pyrogen-free N205 10 x 75 mm 50/pkg Foil wrapped without caps Test Tubes

Pyrogen-free N207 13 x 100 mm 30/pkg Foil wrapped without caps Dilution Tubes

Reagent Reservoir 25-268 10/pkg For use with 8-channel pipettes

Sample Container, 80-507 10 mL Each Glass bottles with screw caps Depyrogenated 80-507L 25/box

80-507U 100/box

Eppendorf BioPur® 25-415 200 µL 5 trays/pkg; Pipette Tips 25-416 300 µL 96 tips/tray Only for multichannel pipettors

25-417 1,000 µL

Stepped Neutral 25-342 For use in ELx808™, ELx808R™, and Kinetic-QCL® plate readers. Density Plate Calibrated against NIST traceable standards.

Ground Aluminum 25-038 Each Holds a 96-well plate in a dry Block with Lid bath multiblock heater

LAL Reagent Grade Plates 25-340 50/case 96-well, <0.0005 EU/well

NEW

NEW

Endotoxin Detection Testing Service InformationOur Testing Service offers you the best in routine and customized endotoxin testing. Our facility is GMP compliantand provides expertise in gel clot, kinetic chromogenic and kinetic turbidimetric assays. All testing is performed inaccordance with FDA Guidelines. Whether you are from a university research laboratory or a QC lab in a majorpharmaceutical company, Cambrex has the capabilities you need for reliable, accurate and confidential results.

Please contact the LAL Testing Service to obtain general information and the LAL Information Sheet: Request for In-House Product Testing.


16

Testing Services

Testing Services

Type of Test U.S. Cat. No. Europe Cat. No. Description

Preliminary Screening of New Product 80-500 80-500

Product Validation Per FDA Guidelines 80-501 80-501 Single lot of product

80-502 80-502 3 lots of product with all lotssubmitted at one time

Sample Testing Endotoxin Determination 80-503 80-503 1 lot, single sample

80-509 80-509 Each additional lot, single sample

Routine Testing FDA End Product Release 80-504 80-504 1 lot, 3 samples

80-510 80-510 Each additional lot, 3 samples

SOP Writing 80-512 —

ß-D-Glucan Testing 80-514 80-511

Custom Depyrogenation — 80-515 Endotoxin Challenge Vials w/Positive Product Controls

Container Depyrogenation — 80-516 Endotoxin Testing w/PositiveProduct Controls

Endotoxin Testing — 80-517 Screening Assay w/PyroGenew/Recombinant Factor C Inhibition/Enhancement Assay

U.S. Testing Service Customers:(800) 654-4452 • (301) 898-7025 ext. 7820Fax: (301) 845-4153e-mail: [email protected]

Sample Shipment:Cambrex Bio Science Walkersville, Inc. LAL Testing Service (B-06)Central Receiving8830 Biggs Ford RoadWalkersville, MD 21793-0127

European Testing Service Customers:Phone: +32-87-32-16-11Fax: +32-87-35-19-67e-mail: [email protected]

[email protected]

Sample Shipment:Cambrex Bio Science, Verviers Parc Industriel de Petit RechainB-4800 VerviersBelgium

Pre-Paid Test Services for EuropeCambrex European LAL Testing Service offers a mail-in pre-paid testing service for users not requiring testingaccording to the pharmaceutical or USP medical device regulations. Pre-paid rapid-endo test packs can be orderedas you would any other product. You will be sent a pre-addressed padded envelope, sample bottles and instructions.Samples can be mailed whenever you have a requirement for an endotoxin test. Samples received using thisservice are tested at the pre-set dilutions indicated below.


17

Testing Services

European Testing ServicesType of Test Cat. No. Description

Rapid-Endotest single water sample 91-101 Tested neat with positive product control

Rapid-Endotest single dialysis fluid sample 91-102 Tested at 1:5 and 1:10 dilutions with positive

product controls

Rapid-Endotest single research sample 91-103 Tested at 1:10, 1:100 and 1:1000 dilutions

with positive product controls

Rapid-Endotest for up to five water samples 95-101 Tested neat with positive product controls

Rapid-Endotest for up to five dialysis fluid samples 95-102 Tested at 1:5 and 1:10 dilutions with positive

product controls

Rapid-Endotest for up to five research samples 95-103 Tested at 1:10, 1:100 and 1:1000 dilutions

with positive product controls

Sample Type Dilutions Result Range (EU) Result Range (pg)

Water None (Neat) 0.005 – 50 0.5 – 5,000

Dialysis Fluids 1:5, 1:10 0.025 – 500 2.5 – 50,000

Research Samples 1:10, 1:100, 1:1000 0.05 – 50,000 5.0 – 5,000,000

European Testing ServiceCustomers:Phone: +32-87-32-16-11Fax: +32-87-35-19-67e-mail: [email protected]

[email protected]

Sample Shipment:Cambrex Bio Science, Verviers Parc Industriel de Petit RechainB-4800 VerviersBelgium

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