Quality control reagents and reference materials from 5-Diagnostics for pharmacopoeial compliance testing under United States Pharmacopeia Chapter 208 (Chromogenic Substrate Assays) and European Pharmacopoeia Chapter 2.7.12 — the mandatory methods for heparin potency determination in pharmaceutical API testing and finished product lot release.
5-Diagnostics supplies a comprehensive range of QC materials specifically formulated to meet the regulatory requirements of pharmaceutical QC laboratories running pharmacopoeial heparin potency assays under GMP.
Reference standards include heparin reference preparations calibrated against the current WHO International Standard for UFH and LMWH, antithrombin (AT) reference concentrates at defined specific activity (IU/mg) traceable to WHO International AT standard, and enzyme reference preparations (bovine Factor Xa, bovine thrombin) at certified specific activity.
System suitability controls — lyophilized plasma preparations at defined heparin activity levels — provide the positive and negative controls required by USP and Ph. Eur. pharmacopoeial method specifications for each analytical batch. Buffer salt QC reagents are formulated to the exact compositions specified in USP Chapter 208 and Ph. Eur. 2.7.12, with verified pH, osmolality, and ionic strength.
All reagents include GMP-compatible certificates of analysis with specification limits, lot traceability, and expiry dating suitable for pharmaceutical quality system documentation.
| Reference | Product Name | Price | ||
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A5D-51426
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5-CLOT NAPTT Reagent | $505.00 | |
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A5D-40401B
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5-PLASMA Normal plasma 5 | $342.00 | |
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A5D-40401A
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5-PLASMA Normal plasma 2 | $206.00 | |
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A5D-44206A
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NAPTT Control-1 (5-CONTROL Factor IXa positive control for NAPTT, 10 mIU/mL) | $289.00 | |
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A5D-44206B
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NAPTT Control-2 (5-CONTROL Factor IXa positive control for NAPTT, 20 mIU/mL) | $289.00 |