Page 1 of 3

Certificate of Analysis

COA_US Print Date: 09-Dec-2019

WALKERSVILLE MD 21793
USA

____________________________________________________________________________

Product Name:
LAL PYROGENT(TM) 125
Material Number: - 16 tests/vial Single Pack
Batch No: F245-125SA
Manufacturing Date: 0000752400
Expiration Date: 30-Aug-2018
30-Aug-2021

____________________________________________________________________________

SPECIFICATION
Test RESULT MIN MAX UNIT
____________________________________________________________________________
F245 matched to 7360
Lysate Product Number: F245-125SA
Lysate Batch 0000752400
Lysate Expiration Date 30 Aug 2021
LYSATE STERILITY:
Bulk Negative NEGATIVE ***
Final Container Negative NEGATIVE ***
CSE Product Number: 7360SA
CSE Batch 0000717825
CSE Expiration Date 11 Dec 2021
Bacterial Strain: E. coli O55: B5
RSE/CSE Ratio (EU/ng) 8 Test & Report ***
CSE Reconstitution Potency (EU/ml) 15 10 40
Calculation of ng/vial 10
FINAL RELEASE TEST
Sensitivity Pass PASS ***
CSE Lot Number (2nd match) 0000757711
CSE Expiration Date (2nd match) 29 Jun 2022
RSE/CSE Ratio (EU/ng) (2nd match) 8 Test & Report ***

This lot has been reviewed by Quality Assurance in compliance with requirements of Lonza's Quality
System. This document was generated from a validated Part 11-compliant electronic system and thus Lonza Walkersville Inc.
handwritten signatures are not required. 8830 Biggs Ford Road
Walkersville, MD 21793 8415
For Technical Assistance, call 1-800-521-0390 Tel (301) 898 7025
Fax (301) 845 4024
 Page 2 of 3

Certificate of Analysis

COA_US Print Date: 09-Dec-2019

WALKERSVILLE MD 21793
USA

____________________________________________________________________________

Product Name:
LAL PYROGENT(TM) 125
Material Number: - 16 tests/vial Single Pack
Batch No: F245-125SA
Manufacturing Date: 0000752400
Expiration Date: 30-Aug-2018
30-Aug-2021

____________________________________________________________________________

SPECIFICATION
Test RESULT MIN MAX UNIT
____________________________________________________________________________
CSE Reconst. Potency (EU/ml) (2nd match) 20 10 40
Calculation of ng/vial (2nd match) 13
Sensitivity (2nd match) Pass PASS ***
Additional Information:
The FDA has stated that the use of a certificate of analysis exempts a firm from having to perform the RSE/CSE
comparison in their own laboratories. However, firms should understand exactly how the LAL manufacturer
performs the test. The procedure detailed below represents the test method currently used at Lonza. Quadruplicate
samples from independent two-fold dilution series are prepared from four (4) separate vials of test CSE. The
samples are used in parallel with one (1) dilution series from a single vial of each RSE and are tested with the
specified lot of LAL reagent. The labeled EU/ml potency on the Certificate of Analysis is calculated from the ratio
of the geometric average endpoint dilution of the RSE and CSE.
Lyophilized (unreconstituted) Limulus Amebocyte Lysate should be stored under refrigeration at 2-8 degrees C.
Reconstituted lysate may be stored at 2-8 degrees C for 24 hours. For longer storage, reconstituted lysate can be
stored at -10 degrees C or colder. Freeze and thaw only once. The lysate should be protected from exposure to light
during storage. Use within four weeks after reconstitution.

The endotoxin vial should be stored at 2-8 degrees C prior to reconstitution. Reconstitute with 5.0 ml LAL Reagent
Water. Store reconstituted vial at 2-8 degrees C for up to 4 weeks.
This lot has been reviewed by Quality Assurance in compliance with requirements of Lonza's
Quality System. This document was generated from a validated Part 11-compliant electronic system Lonza Walkersville Inc.
and thus handwritten signatures are not required. 8830 Biggs Ford Road
Walkersville, MD 21793 8415
For Technical Assistance, call 1-800-521-0390 Tel (301) 898 7025
Fax (301) 845 4024
 Page 3 of 3

Certificate of Analysis

COA_US Print Date: 09-Dec-2019

WALKERSVILLE MD 21793
USA

____________________________________________________________________________

Product Name:
LAL PYROGENT(TM) 125
Material Number: - 16 tests/vial Single Pack
Batch No: F245-125SA
Manufacturing Date: 0000752400
Expiration Date: 30-Aug-2018
30-Aug-2021

____________________________________________________________________________

SPECIFICATION
Test RESULT MIN MAX UNIT
____________________________________________________________________________

If product F245-125SA has been matched to multiple lots of 7360SA endotoxin, the results for each match are
indicated separately by lot number.

Leah Baltos
Electronically signed by Leah Baltos
Date: 29-NOV-2018 16:27:53 EST
RELEASE ( Inspection Lot: Usage Decision )

This lot has been reviewed by Quality Assurance in compliance with requirements of Lonza's
Quality System. This document was generated from a validated Part 11-compliant electronic system Lonza Walkersville Inc.
and thus handwritten signatures are not required. 8830 Biggs Ford Road
Walkersville, MD 21793 8415
For Technical Assistance, call 1-800-521-0390 Tel (301) 898 7025
Fax (301) 845 4024