PRODUCT MANUFACTURING PRACTICUM INJECTION IN VIAL I. FORMULA Acidum Folicum 0.5% Injectable medication in 10 ml vial no. II. SPECIFICATION A. Efficacious Ingredients: Acidum Folicum Description: yellowish brown powder (FI III, 51) Solubility: Insoluble in water (FI III), soluble in weak bases, alkali hydroxides, alkali carbonate, NaOH, HCl (Martindale 28, 1647) Melting/melting point: B. Dosage Usual dose : : im 15mg/day (FI III, 959) Max dose : Dosage calculation: C. Medication List Hard drugs: Injection preparations (all injectable drugs including hard drugs) D. Medicinal preparations Description : Solution Stability : OTT : against oxidizing agents, reducing agents, heavy metals (Martindale, 1647 pH : 8-11 Preservative : Antioxidant : Edetas disodium 0.05% Additional Substances: NaOH 0.1N Stabilizer: Dinatrii edetas (Chelating Agent) E. Tonicity: Completeness: Substance : Sodium Folate ∆tb = 0.069 C = 0.526 Substance : Dinatrii Edetas ∆tb = 0.132 C = 0.05 C Sodium Folate is obtained from the calculation: C= C= Tonicity Calculation W= W= W = 0.8283% (hypotonic) → if positive it means hypotonic To make the solution isotonic, 0.8283% (w/v) NaCl was added. III. STERILIZATION A. Tools and Materials Tool Sterilization Time Beaker glass Oven 170°C 30' Funnel & filter paper Autoclave 115-116°C 30' Vial Oven 170°C 30' Watch glass Direct fire 20” Metal spatula Direct fire 20” Stirring rod Direct fire 20” Syringe B. Preparations Sterilized by sterilization method A or C (Fornas 2, 12) IV. COMPLETE FORMULA Acidum Folicum 0.5% Natrii Chloridum 0.8283% Dinatrii Edetas 0.05% Natrii Hydroxidum 0.1N ad soluble Aqua pro injectionum ad 10ml V. WEIGHING Material Basic Unit 10 ml Acidum Folicum 50mg NaCl 82.83mg Dinatrii Edetas 5mg Production Volume Initials VI. PROCESSING No. Processing Initials 1. Boil 100ml aqua pro injectionum (fire) in a beaker glass for 10 minutes (hour......to......) 2. Suspend folic acid in a portion of fire (M1) 3. Add 0.1N NaOH solution to the suspension (M1) until dissolved. Required ........ drops (M2) 4. Dissolve NaCl in some fire (M3) 5. The two mixtures are mixed (M2 and M3) 6. Add Dinatrii Edetas solution (check pH 9) 7. The solution was added to the fire ad ........ ml 8. The solution is filtered and the first filtrate is discarded 9. The solution is then filled into ..... vial @ 10.5ml 10. Sterilization in autoclave 115-1160C for 30 minutes (hour.........to/d.........)