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Key Documents

Safety Information

MATFSL1

Millipore

FSL-1 Non-Endotoxin Pyrogen (NEP) Control

for use with PyroMAT®

Synonym(s):

Lipoprotein

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Select a Size

50 μG
CN¥1,033.50
250 μG
CN¥3,704.33

CN¥1,033.50


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50 μG
CN¥1,033.50
250 μG
CN¥3,704.33

About This Item

UNSPSC Code:
41116129
NACRES:
NA.74

CN¥1,033.50


Please contact Customer Service for Availability

Request more information

Agency

EP
JP 4.06
USP

Quality Level

form

lyophilized

manufacturer/tradename

PyroMAT®

application(s)

pharmaceutical
pyrogen testing

compatibility

for use with PyroMAT®

shipped in

ambient

storage temp.

2-8°C

suitability

pyrogenic bacteria

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assay range

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(FABP4), inter-assay cv: <20%
intra-assay cv: <10%, accuracy: 103%
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(FABP3), standard curve range: 68.6-50,000 pg/mL
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(LIGHT), standard curve range: 34.3-25,000 pg/mL
(NT proBNP, CXCL16, Endocan-1 (ESM-1), LIGHT), accuracy: 96%
(Placental Growth Factor (PlGF))

assay range

accuracy: 103%
(Thrombomodulin), accuracy: 104%
(Pentraxin-3 (PTX3)), accuracy: 104%
(Tissue Factor (TF)), accuracy: 106%
(Pecam-1), accuracy: 109%
(sE-Selectin), standard curve range: 0.01-5 ng/mL
(Troponin T (TnT)), standard curve range: 0.04-30 ng/mL
(Follistatin (FST)), standard curve range: 0.14-100 ng/mL
(Pentraxin-3 (PTX3) & Tissue Factor (TF)), standard curve range: 0.27-200 ng/mL
(Pecam-1), standard curve range: 0.34-250 ng/mL
(Thrombomodulin), standard curve range: 2.7-2,000 ng/mL
(sE-Selectin), inter-assay cv: <20%
intra-assay cv: <10%

assay range

accuracy: 102%
(Haptoglobin), accuracy: 109%
(AGP), accuracy: 113%
(Platelet Factor-4), accuracy: 117%
(Adipsin), standard curve range: 0.004-15 ng/mL
(L-Selectin & SAP), standard curve range: 0.012-50 ng/mL
(CRP), standard curve range: 0.037-150 ng/mL
(PF4), standard curve range: 0.061-250 ng/mL
(HPTGN), standard curve range: 0.098-400 ng/mL
(AGP & Adipsin), standard curve range: 0.244-1,000 ng/mL
(Fetuin A & vWF), standard curve range: 0.488-2,000 ng/mL
(A2M)

assay range

accuracy: 88%
(Myoglobin), accuracy: 90%
(P-selectin), accuracy: 98%
(GDF-15), standard curve range: 0.0005-2.5 ng/mL
(GDF-15), standard curve range: 0.012-50 ng/mL
(Lipocalcin-2/NGAL), standard curve range: 0.024-100 ng/mL
(Myoglobin & MPO), standard curve range: 0.085-350 ng/mL
(sICAM-1), standard curve range: 0.122-500 ng/mL
(sVCAM-1), standard curve range: 0.244-1,000 ng/mL
(D-dimer, SAA & P-selectin), standard curve range: 1.221-5,000 ng/mL
(ADAMTS 13), inter-assay cv: <20%
intra-assay cv: <15%

manufacturer/tradename

Milliplex®

manufacturer/tradename

Milliplex®

manufacturer/tradename

Milliplex®

manufacturer/tradename

Milliplex®

Quality Level

200

Quality Level

200

Quality Level

200

Quality Level

200

technique(s)

multiplexing: suitable

technique(s)

multiplexing: suitable

technique(s)

multiplexing: suitable

technique(s)

multiplexing: suitable

shipped in

wet ice

shipped in

wet ice

shipped in

wet ice

shipped in

wet ice

General description

FSL-1 is a non-endotoxin pyrogen which will serve as a positive control during pyrogen testing with PyroMAT® system.Non- Endotoxin Pyrogen (NEP) Control FSL-1 is a synthetic lipoprotein derived from Mycoplasma salivarium, supplied in a lyophilized form. FSL-1 Non- Endotoxin Pyrogen (NEP) Control activates TLR2/TLR6 receptor of monocytes and is used as a positive control for PyroMAT® system. The response to pyrogenic substances is determined by measuring the Interleukin-6 (IL-6) produced by the monocytes using ELISA microplate.

Application

FSL-1 control can be used as a positive control with the PyroMAT® System. It is to be used for Product Specific Validation (PSV) and routine testing to show that the system can detect non-endotoxin pyrogen contaminants in pharmaceutical products.

Legal Information

PYROMAT is a registered trademark of Merck KGaA, Darmstadt, Germany

Storage Class Code

11 - Combustible Solids

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Regulatory Information

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