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B L Lifesciences Pvt. LTD

The document is an inhibition/enhancement test report from BL Lifesciences Pvt. Ltd. testing an unnamed product. It provides details of the reagents, endotoxin and LAL reagent water used. It then lists details of the product tested including name, batch number, potency, and endotoxin limit. The report describes the control curve details showing standard dilutions and observations. Next, it outlines the product curve details showing test dilutions of the product. Finally, it states whether the test material passed or failed the test for inhibition/enhancement according to specifications.

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99 views2 pages

B L Lifesciences Pvt. LTD

The document is an inhibition/enhancement test report from BL Lifesciences Pvt. Ltd. testing an unnamed product. It provides details of the reagents, endotoxin and LAL reagent water used. It then lists details of the product tested including name, batch number, potency, and endotoxin limit. The report describes the control curve details showing standard dilutions and observations. Next, it outlines the product curve details showing test dilutions of the product. Finally, it states whether the test material passed or failed the test for inhibition/enhancement according to specifications.

Uploaded by

nishtha
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as DOCX, PDF, TXT or read online on Scribd
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B L LIFESCIENCES PVT. LTD.

Corporate Office: A-245, Okhla Industrial Area, Phase-I, New Delhi, India

INHIBITION/ENHANCEMENT TEST REPORT


Document Ref. No. BL-HR-001-03B Effective Date 08-09-2021
Revision 01 Page No. 1 of 2

1. Details of Reagents, Endotoxin and LAL Reagent Water:

LAL Lot No.: _____________ Sensitivity: _________________


Expiry Date: _____________ Endotoxin Lot No.: ___________
Potency: ________________ Expiry Date: ________________
Endotoxin Reconstituted on: ____________ LRW Lot No.: _______________
Expiry Date:________________ Opened on:_____________

2. Details of Product Tested:

Name: ______________________ Batch No.: _________________


Potency: ____________________ Endotoxin Limit:_____________
Max. Valid Diln.: ______________ Test Dilution: _______________
Test Date: _______________ IncubationTemp.____________
Incubation Period: ________

3. Dilution Details:

Standard Endotoxin Dilution Product Dilution

4. Control Curve Details:


OBSERVATION
S.No. Dilution LRW CSE Product Lysate 1 2 3 4
(µl) (µl) (µl) (µl)
1. NA 100 NA NA 100
2. 2λ 50 50 (of 4 λ) NA 100
3. λ 75 25 (of 4 λ) NA 100
4. λ/2 50 50 (of λ) NA 100
5. λ/4 75 25 (of λ) NA 100

5. Product Curve Details:

S.No. Dilution LRW CSE Product Lysate 1 2 3 4


(µl) (µl) MVD/2(µl) (µl)
1. NPC 50 NA 50 100
2. PPC 2λ NA 50 (of 4λ) 50 100
3. PPC λ 25 25 (of 4λ) 50 100
4. PPC λ/2 50 50 (of λ) 50 100
5. λ/4 75 25 (of λ) 50 100
Negative:- No clot. Positive:- With clot.

5. Remark:

The above test material complies/does not complies the Test for Inhibition/Enhancement as per
specification.

Manufacturing Site: Unit-II- D-31, Site IV, UPSIDC Industrial Area Greater Noida, Gautam Buddha Nagar, Uttar Pradesh-(India)-201306
B L LIFESCIENCES PVT. LTD.
Corporate Office: A-245, Okhla Industrial Area, Phase-I, New Delhi, India

INHIBITION/ENHANCEMENT TEST REPORT


Document Ref. No. BL-HR-001-03B Effective Date 08-09-2021
Revision 01 Page No. 2 of 2

Tested by: _______________________ Date: _________________

Reviewed by: _____________________ Date: _________________

ABBREVIATIONS:
LAL – Limulus Amebocyte Lysate. LRW – LAL Reagent Water.
MVD – Maximum Valid Dilution. CSE – Control Standard Endotoxin.
NPC – Negative product Control. PPC – Positive Product Control.
NWC – Negative Water Control. PWC – Positive Water Control.

Manufacturing Site: Unit-II- D-31, Site IV, UPSIDC Industrial Area Greater Noida, Gautam Buddha Nagar, Uttar Pradesh-(India)-201306

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