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Dexa Medica sell "Bendamustine 25, 100"

Basic Information

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Trade Type

Sell

Product Name

Bendamustine 25, 100

Manufacturer(s)

Specifications

  • Loss on Drying: Residual moisture of the lyophilized cake tightly controlled to preserve stability of the 25 mg/100 mg powder-for-injection presentations
  • Clarity of Solution: Reconstituted solution clear and free from visible particulate matter, suitable for IV infusion
  • Assay: Bendamustine hydrochloride content per vial verified within compendial assay limits for 25 mg and 100 mg strengths
  • Impurity Profile: Related-substance impurity profile (including hydrolysis/dimer degradants) controlled within compendial limits

Documents

CEP Certificate
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GMP
ISO
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