BIEM ILAC SANAYI VE TICARET A.S sell "Gadonans (Gadobutrol)"
Basic Information
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Category
Subcategory & Sub-subcategory
Trade Type
Sell
Product Name
Gadonans (Gadobutrol)
Details
Manufacturer(s)
Specifications
- Sterility: Sterile; no growth detected per USP <71>/Ph.Eur. 2.6.1 membrane filtration or direct inoculation test
- Bacterial Endotoxins: <0.5 EU/mL (or per-dose limit as applicable), tested by LAL assay per USP <85>/Ph.Eur. 2.6.14
- Particulate Matter: Complies with USP <788>/Ph.Eur. 2.9.19 sub-visible particulate limits for parenteral/ophthalmic/nasal products
- Container Closure Integrity: Validated per USP <1207> to ensure the container-closure system prevents microbial ingress and maintains product sterility/stability through shelf life
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