PRODUCT MANUFACTURING PRACTICUM INJECTION IN AN AMPULE I. FORMULA Aneurin Hydrochloridum 25mg/ml Injectable drug in 1ml ampoule no. ....... II. SPECIFICATION A. Efficacious Ingredients: Aneurin Hydrochloridum Appearance: white or colorless powder or white crystals or white powder Solubility: soluble in 1: 1 part water Melting point: ± 2480C (FI IV) B. Dosage Usual dose : : im/iv 10-100mg for therapy Max dose : Dosage calculation: C. Medication List Hard drugs: Injection preparations (all injectable drugs including hard drugs) D. Medicinal preparations Description : Clear solution Stability : See Martindale/Fornas OTT : against oxidizing agents, reducing agents, alkalis pH : 2.8-3.4, 2.5-4.5 Added HCl as a pH stabilizer Preservative : Antioxidant : - CO free water2and O2 E. Tonicity: Completeness See Brand Index ed.8, 1277 Substance ∆tb C Thiamine HCl 0.139 2.5 Tonicity Calculation W= W= W = 0.2995% (hypotonic) → if positive it means hypotonic To make the solution isotonic, 0.2995% (w/v) NaCl was added. III. STERILIZATION C. Tools and Materials Tool Sterilization Time Beaker glass Oven 170°C 30' Funnel & filter paper Autoclave 115-116°C 30' Ampoule Oven 170°C 30' Watch glass Direct fire 20” Metal spatula Direct fire 20” Stirring rod Direct fire 20” Initials Syringe D. Preparations Sterilized by sterilization method A or C and immediately cooled IV. COMPLETE FORMULA Aneurin Hydrochloridum 25mg Natrii Chloridum 2,995mg Acidum Hydrochloridum 0.1 N ad pH stability Aqua pro injectionum ad 1ml V. WEIGHING Material Basic Unit Production Volume 1ml Aneurin HCl 25mg NaCl 2,995mg VI. PROCESSING No. Processing Initials 1. Dissolution of Aneurin HCl in partially CO-free flame2 and O2 2. Dissolve NaCl in part of the fire 3. The two mixtures are mixed 4. Add fire ±....ml then check the pH Initial pH = ............. Final pH = ........... 5. Add 0.1N HCl as many as ........ drops until the pH is stable 6. The solution was added to the fire ad ........ ml 7. The solution is filtered and the first filtrate is discarded Initials 8. The solution is then filled into ..... ampoules @ 1.1ml 9. Sterilization in autoclave 115-1160C for 30 minutes (hour.........to/d.........)