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Hameln rds has received CEP from EDQM for API SUFENTANIL CITRATE, we will be happy to prepare you a quote.
- Piritramide
- Alfentanil Hydrochloride(CEP)
- Sufentanil Base(CEP)
- Remifentanil Hydrochloride (CEP)
- Propentofylline
- Moxastini Theoclas
- Dexmedetomidine
- Noradrenaline Tartrate
- Sufentanil Citrate
- Established GMP certificate since December 2012
- Production focused on manufacture of API class OEB 3 to OEB 5
- Production capacity 100 kg of high potent APIs per year in the 1st facility
- Production capacity 500 kg of high potent APIs and Intermediates per year in the 2nd facility
- Production of API and intermediates fully compliant with GMP rule
- Batch size of produced batches in range 100 g – 5 000 g
- Rooms for safety production of HP API with thorough filtration of air input and exhaust
- Full protection of staff and products
- Monitoring of water waste with unit for decomposition of dangerous pollutant
- Reaction in temperature range 20°C to +140°C
- Reaction (hydrogenation) under higher pressure (12 bar)
- Extraction
- Filtration
- Evaporation
- Crystallisation and Isolation
- Drying with raking in process filter or on trays in drying oven
Sieving
- 2 glass reactors double jacketed 30 – 50 L, connected with thermostat temperature range: 20°C to +140°C
- 1 glass 50 L reactor for crystallisation connected to process filter temperature range: 20°C to +140°C
- process filter with capacity maximally 5.000 g
- sieving and milling device
- 50 L hydrogenator for work pressure up to 12 bar (in construction)
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