Antibiotic Razgrad AD sell "Dex - Tobrin"
Basic Information
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Product Name
Dex - Tobrin
Details
Manufacturer(s)
Specifications
- Sterility: Sterile product; complies with the USP <71>/Ph.Eur. 2.6.1 sterility test
- Bacterial Endotoxins: Complies with the pharmacopoeial bacterial endotoxin limit per USP <85>/Ph.Eur. 2.6.14 (dose-based limit)
- Particulate Matter: Complies with USP <788>/Ph.Eur. 2.9.19 particulate matter limits for injectable/ophthalmic products
- Container Closure Integrity: Verified by validated container-closure integrity testing (e.g., dye ingress or vacuum decay) per USP <1207>
Other Information
Additional Description:
Dex-Tobrin (INN: dexamethasone plus tobramycin) is an eye drop formulation at 3 mg/ml plus 1 mg/ml strength, supplied in a 5 ml dropper-bottle solution with a 2-year shelf life and a 12,000-vial batch size. It holds marketing authorization and an eCTD dossier.
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