Antibiotic Razgrad AD sell "Dexamethasone/ Prednisolone F"
Basic Information
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Category
Subcategory & Sub-subcategory
Trade Type
Sell
Product Name
Dexamethasone/ Prednisolone F
Manufacturer(s)
Specifications
- Content Uniformity: Complies with pharmacopoeial content/weight uniformity limits (USP <905>/Ph.Eur. 2.9.40)
- Disintegration Time: Complies with pharmacopoeial disintegration time limits (USP <701>/Ph.Eur. 2.9.1), typically ≤30 minutes for immediate-release forms
- Hardness: Within the validated in-process hardness specification (typically 4-10 kp), ensuring adequate mechanical strength
- Friability: ≤1.0% w/w weight loss, per USP <1216>/Ph.Eur. 2.9.7 friability test
- Tablet Thickness: Controlled within ±5% of target thickness per validated in-process specification
Other Information
Additional Description:
Dexamethasone/Prednisolone F (INN: dexamethasone) is a tablet formulation at 2 mg/0.5 mg strength, supplied in packs of 30 or 50 tablets (blister strips of 10) with a 2-year shelf life and batch sizes of 500,000 or 1,000,000 tablets. It holds marketing authorization and an eCTD dossier.
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