Grupo Azevedos sell "Dimenhydrinate"

Manufacturer · Contract & Outsourcing ServicesPortugal

Basic Information

235

14

3

3.5(6)

Category

Finished Dosage Forms

Subcategory & Sub-subcategory

Other/Unclassified Dosage Forms / Other Unclassified Dosage Forms

Trade Type

Sell

Product Name

Dimenhydrinate

Details

Substance

Manufacturer(s)

Grupo Azevedos - Portugal

Specifications

CAS Number: 523-87-5
EC Number: 208-350-8
Molecular Weight: 470
Chemical Formula: C₂₄H₂₈ClN₅O₃
Content Uniformity: Complies with pharmacopoeial content/weight uniformity limits (USP <905>/Ph.Eur. 2.9.40)
IUPAC Name: 2-benzhydryloxy-N,N-dimethylethanamine;8-chloro-1,3-dimethyl-7H-purine-2,6-dione
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

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