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Pharmaceuticals control
Reagent kits for quality control departments of the pharmaceutical companies
Heparin control in drugs and substances
1. Chromogenic methods according to European Pharmacopoeia 8.0:
- Renaparin test. Reagent kits for detection of anti Xa and anti IIa LMWH activity
- Renaparin-unfractionated heparin (UFH) test. A reagent kit for determination of anti Xa and anti IIa activity of unfractionated heparin.
2. Clotting methods:
- Reagents for determining the unfractionated heparin activity:
- APTT-UFH reagent;
- Calcium chloride - 6x5 ml (Calcium chloride 0.025 M solution)
- Calcium chloride - 6x10 ml (Calcium chloride 0.025 M solution)
- Working Standard Sample of the unfractionated heparin.
3. Reagent kit for identification of sodium citrate in anticoagulants.
Detection of the plasma preparations activity
Clotting methods for determining activity of clotting factors:
- Substrate-deficient plasma:
- APTT-EK test
- RenaUplastin
- Working Standard Samples of Activity:
- Factor VIII
- Factor IX
- Antithrombin III
- Fibrinogen
- Thrombin.
There are 6 products.
Fibrinogen test-U (160-320) Reagent kit for determination the fibrinogen by Clauss's method. Designed for usage on all types of semi-automatic and some automatic coagulometers, which use reagents without kaolin.
Product code: РенаУ ПГ-10/1
Reagents for determination: fibrinogen conc.
Number of detections: 160-320
RenaUplastin 8 ml No.10 Thromboplastin (from a rabbit brain) for determination of the prothrombin time. Lyophilically dried ready-to-use mixture of thromboplastin and calcium chloride ISI-certified (1,1-1,2).
Product code: РенаУ ПГ- 5/1
Reagents for determination: prothrombin test
Thrombin-Reagent-U 200-600 determinations Reagent kit for the detection of the thrombin time.
Product code: РенаУ ПГ-9А
Reagents for determination: prothrombin test
Number of detections: 200-600
Factor-U IX test Reagent kit for detection of the IX blood clotting factor activity. For hemophilia B and thrombophilia diagnosis, detection of inhibitors to factor IX.
Product code: РенаУ ФС-2
Number of detections: 10-20
APTT EK test The kit is designed for tests: activated partial thromboplastin time (APTT), partial thromboplastin time (PTT) (kephalin time), activated plasma recalcification time (APRT) (kaolin time) in blood plasma both manually and on semi-automatic and automatic coagulometers. They are able to record clot formation in the kaolin presence.
Product code: РенаУ ПГ-6
Reagents for determination: APTT
Number of detections: 100-200
Plasma substrate VIII KM-6 Factor VIII Deficient Substrate Plasma (VIII substrate plasma)
Product code: РенаУ КМ-6
Number of detections: 120
