Ampul n Vial

7/31/2019 Ampul n Vial

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Created by : Twoster inc.


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Members of this group :Ayu AshariSoendaria IntanFaisah

Khairul AmrySasmita SariNurrahmi Putri AnggraeniIndah

Name of Our Company :Twoster Inc.


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Name : AmVit C ampul

Amount : 7 bottle @ 1ml


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Original Formula

Formulation date : 1st

April 2012Production date : 4 th May 2012Reg. No. : DKL1200200443A1Batch No. : TW02004

Planing :No.

Material Name Fungsion Number for Set Number forBatch

1. Ascorbic acid Active ingr. 100 mg 1 g

2. Sodium EDTA Sequistering agent 0,5 mg 5 mg

3. Sodium bisulfit antioxidant 0,1 mg 1 mg

4. Sodium bicarbonat/HCl pH adjustment Qs(until pH 6,5) qs

5. Aqua pro injection vehicle Ad 1 ml Ad 10 ml


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pH of this solution is about 6,5

Have to be a clear solution without color

About 1ml of this solution is functional

Using glass bottle type 1.

Volume of one use 1ml

Using filter method for sterilization of this solution and terminal sterilization

for the bottle, using autoclaving 121 0 C, 30 minute for sterilization

Using aseptic condition

Sodium bicarbonat and HCl 0,1 N for pH adjustment

Single dose for vit C acute deficiency


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Vit CSodium EDTASodium bisulfit

NaOHSodium bicarbonatAqua pro injection


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No. Ingredients/tools/preparation

Sterilization method

1. Glass Bottle autoclave, 121C, 15 minutes2. Parchament paper Oven, 170C, 1 hour

3. Measure glass autoclave, 121C, 15 minutes

4. Glove sterile -

5. Glass stick Oven, 170C, 1 jam

6. Horn spoon autoclave, 121C, 15 minutes

7. Erlenmeyer Oven, 170C, 1 jam

8. Beker glass autoclave, 121C, 15 minutes

9. Vit C Filter methode

10. Sodium EDTA autoclave, 115 0C, 30 minutes

11. Sodium bisulfit autoclave, 115 0C, 30 minutes

12. NaOH autoclave, 115 0C, 30 minutes

13. Sodium bicarbonat autoclave, 121C, 15 minutes

14. Aqua pro injection (sterile) -


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Tonicity

B = 0,52 (PTB vit C x Consentration of vit C)PTB NaCl

B = 0,52 (0,105 x 10)0,576

= -0,92 (hipertonicity)


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Prepared all the equipment and materialsSterilized all equipment and materials. Especially, for the glass equipment. Make itfree-alkalizing with soaking the glass equipment in HCl 0,1 N (which is mixture inhot water). The materials are sterilized with appropriate methode.For the rubber equipment, make it free-sulfur with soaking the rubber equipmentin 2% Sodium Bicarbonat which is mixture with 0,1% Sodium lauryl sulfate.Weighing all the materials that required

Dissolve Sodium bisulfit in API for vehicle.Dissolve Ascorbic acid in a part of API that mixture with Sodium bisulfit before (+10ml). (Part 1)Add Sodium EDTA in part 1. (part 2)Check pH solution with pH indicator/pH universal.To achive pH 6,5, add drop by drop pH adjustment. Make it sure by using the pHindicator.Add drop to drop the buffer to part 2.Fill in appropriate plastic bottle container.


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Gennaro,A.R, et all. Rhemingtons Pharmaceutical Science,18 th Edition. Marck Publishing Company: Pensylvania. 1990.Jenkins, Glen, dkk. Scovilles The Art of Compounding , MCGrowhill, Book Company: New York. 1957.Kibbe, Arthur. Handbook of Pharmaceutical Excipient. American Pharmaceutical Ass: Washington DC. 1980.Martin, W, Inc. Dispending of Medication, 7 th Edition. MarckPublishing Company: USA. 1971.Reynads,I.E.F. Martindale The Extra Pharmacopeia , Department of Pharmaceutical Science. Marck Publishing

Company, Easton: Pensylvania. 1993Torce, Salvatore dan Robert S King. Sterile Dosage Form. Lea Febinger: Philadelphia. 1973.


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Members of this group : Ayu Ashari Soendaria Intan Faisah Khairul Amry Sasmita Sari Nurrahmi Putri Anggraeni Indah

Name of Our Company : Twoster Inc.


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Name : Lidosfer vialAmount : 7 bottle @ 10 ml


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Original Formula Formulation date : 1 st April 2012 Production date : 4 th May 2012 Reg. No. : DKL1200200544A1

Batch No. : TW02005Planing

No. Material Name Function Number for Set Number forBatch

1. Lidokain HCl Active ingr. 250 mg 7,7 g

2. NaCl Isotonic agent 548 mg 0,0077 g

3. Benzalconium clorida Preservative 5 mg 0,05 g

4. Sodium Bicarbonat pH adjustment q.s (till pH 6,5) q.s (till pH 6,5)

5. Aqua pro injection vehicle Ad 50 ml Ad 510 ml


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pH of this solution is about 6,5Have to be a clear solution without color

About 50 ml in multiple-dose. For local anethetic injection used 10 ml.

Using glass bottle type 1.

Volume of one use 10 ml

Using autoclave method for sterilization of this solution and terminal

sterilization

For the bottle, using autoclafing 121 0 C, 30 minute for sterilization

Using aseptic condition

Sodium bicarbonate for pH adjustment


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Lidokain HClNaCl

Benzalconium cloridaSodium BicarbonatAqua pro injection


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No. Ingredients/tools/preparation

Sterilization method

1. Glass Bottle autoclave, 121C, 15 minutes2. Parchment paper Oven, 170C, 1 hour

3. Measure glass autoclave, 121C, 15 minutes

4. Glove sterile -

5. Glass stick Oven, 170C, 1 jam6. Horn spoon autoclave, 121C, 15 minutes

7. erlenmeyer Oven, 170C, 1 jam

8. Beker glass autoclave, 121C, 15 minutes

9. Lidokain HCl autoclave, 115 0C, 30 minutes

10. NaCl autoclave, 121C, 15 minutes/filtrasi

11. Benzalconium clorida autoclave, 121C, 15 minutes

12. Sodium Bicarbonat autoclave, 121C, 15 minutes

13. Aqua pro injection -


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TonicityB = 0,52 (PTB lidocain HCl x Consentration of Lidocain HCl)

PTB NaCl

B = 0,52 (0,13 x1)0,576

= 0,677708 g/100ml (hipotonicity)For 50 ml =

50 x 0,677708 = 0,3385 g = 338,5 mg100


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Prepared all the equipment and materialsSterilized all equipment and materials. Especially, for the glass equipment.Make it free-alkalizing with soaking the glass equipment in HCl 0,1 N (which ismixture in hot water). The materials are sterilized with appropriate methode.For the rubber equipment, make it free-sulfur with soaking the rubber equipment in 2% Sodium Bicarbonat which is mixture with 0,1% Sodium laurylsulfate.Especially for seal rubber (vial sealing rubber), satiate with the activeingredient (in solution) or in preservative solution.Weighing all the materials that requiredDissolve Lidocain HCl in API for vehicle. Part 1Add NaCl in part 1, and mixture with API that left. (part 2)Check pH solution with pH indicator/pH universal.To achive pH 6,5, add drop by drop pH adjustment. Make it sure by using thepH indicator.Add drop to drop the buffer to part 2.The solution used terminal sterilization with autoclave 121 0C, 30 minute Fill in appropriate glass bottle container.


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Gennaro,A.R, et all. Rhemingtons PharmaceuticalScience, 18 th Edition. Marck Publishing Company:Pensylvania. 1990.Jenkins, Glen, dkk. Scovilles The Art of Compounding ,MC Growhill, Book Company: New York. 1957.

Kibbe, Arthur. Handbook of Pharmaceutical Excipient. American Pharmaceutical Ass: Washington DC. 1980.Martin, W, Inc. Dispending of Medication, 7 th Edition. Marck Publishing Company: USA. 1971.Reynads,I.E.F. Martindale The Extra Pharmacopeia , Department of Pharmaceutical Science. Marck Publishing Company, Easton: Pensylvania. 1993Torce, Salvatore dan Robert S King. Sterile Dosage Form. Lea Febinger: Philadelphia. 1973.

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Ampul n Vial