Certificate of Analysis

Certificate of Analysis
Product name
Mab <CK-MM> Mix
Material No.
04688457103
Lot No.
Date of Manufacturing
Expiry Date
15601745
2016-10-18
2019-10
Parameter
Result
Unit
Appearance
deep-frozen solution
Appearance after thaw
clear to slightly opal
pH (25 deg. C)
7,4
Protein(BCA reag.)
12,0
mg/ml
HPLC(Mono Q)
94
%
aggregates (TSK 3000)
0
%
inhibitor capacity
corresponds
CK-MM; 4500 U/L (37 deg. C)
99,6
%
CK-BB; 300 U/L (37 deg. C)
-1
%
pH 5.5-treatment (30 min.)
corresponds
This lot meets our specification
Issue date 2016-10-18
Page 1 of 2
Roche Diagnostics GmbH
Sandhofer Straße 116; D#68305 Mannheim; Telefon +49-621-759-0; Telefax +49-621-759-2890
Sitz der Gesellschaft: Mannheim - Registergericht: AG Mannheim HRB 3962 - Geschäftsführung: Dr. Ursula Redeker,
Sprecherin; Edgar Vieth - Aufsichtsratsvorsitzender: Dr. Severin Schwan
Certificate of Analysis
Product name
Mab <CK-MM> Mix
Material No.
04688457103
Lot No.
Date of Manufacturing
Expiry Date
15601745
2016-10-18
2019-10
This certificate is a computer printout and has therefore not been signed by hand.
Issue date 2016-10-18
Page 2 of 2
Roche Diagnostics GmbH
Sandhofer Straße 116; D#68305 Mannheim; Telefon +49-621-759-0; Telefax +49-621-759-2890
Sitz der Gesellschaft: Mannheim - Registergericht: AG Mannheim HRB 3962 - Geschäftsführung: Dr. Ursula Redeker,
Sprecherin; Edgar Vieth - Aufsichtsratsvorsitzender: Dr. Severin Schwan

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