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master formula record ethamsylate 250 mg injection 2 ml

 

 

 

master formula record ethamsylate 250 mg injection 2 ml

master formula record ethamsylate 250 mg injection 2 ml batch size: 525 liters

PRODUCT CODE
GENERIC NAME Ethamsylate injection 250 mg/2 ml
LABEL CLAIM

 

Each ml. contains
Ethamsylate  . 125 mg
Water for Injection q. s.
STANDARD BATCH SIZE: 525 Liters
PRIMARY PACK DECRIPTION 2 ml Amber Glass Ampoule with Blue Ring
PRODUCT DECRIPTION Clear ,colorless solution
STORAGE CONDITION Store Protected from Light and Moisture

2.0. TABLE OF CONTENT :

Sr. No. Contents
1.0. PRODUCT INFORMATION
2.0 TABLE OF CONTENT
3.0 BILL OF RAW MATERIAL
4.0 CALCULATIONS
5.0 BATCH MANUFACTURING  PROCESS
6.0 PRECAUTION
7.0 YIELD AND ACCOUNTABILITY

3.0. BILL OF RAW MATERIAL :

Sr.

No.

INGRADIENTS Label

clam

Standard

Qty(Kg)

Overages(%)     Batch Qty(Kg)
1. Ethamsylate 125 mg 67.594 kg 3% 67.594 kg
2. Sodium Meta BI Sulphate 2.625kg

 

          – 2.625 kg

 

3. DI Sodium EDTA  LR Grade 0.262 kg           – 0.262 kg
4. Methylparaben 0.420  kg           – 0.420  kg
5. Proplyparaben 0.105kg

 

0.105 kg

 

6. Propylene Glycol (PG) 109.20  kg 109.2    kg
7. Hydrochloric Acid ( Hcl) 0.125  Ltr. 0.125    Ltr.
8. Sodium Hydroxide Pellets( NAOH) 0.125 kg 0.125   kg
9. Water for    Injection (WFI) q.s. q.s.

4.0 CALCULATIONS :

LABEL CLAIM:

Each ml Contains:

Ethamsylate B.P.                        125 mg

Water for Injection B.P.               q.s.

 

 

Calculation for Ethamsylate B.P.

 

  1. A,R.No.  :_________________

Assay on Anhy. Basis: __________ %                         Water………………. %

 

Ethamsylate B.P.  =   125 x Batch Size x100 x100_  =…. ………Kg of Ethamsylate B.P. (X)

—                                       —                      —  Assay x (100-Water) x1000

 

5.0. BATCH MANUFACTURING PROCESS :



• Ensure That compounding Vessel is cleaned before starting the procedure.
• Collect Water for Injection according to Batch size in a Mixing vessel send BET sample and

cool up to 80- 85°C with continuous nitrogen Purging.
• From the step 1st take Water for Injection a side in other SS vessel according to Batch size for final volume make up.
• Add and dissolve Methylparaben BP with continuous stirring and check the clarity of solution.
• Add and dissolve Proplyparaben BP with continuous stirring and check the clarity of solution.
• Start the cooling water to the jacket of mixing vessel. Start the stirrer and maintain the stirring

speed between 2200 to 2880 RPM and cool the WFI to 45 – 50 °C.
• Add and dissolve DI Sodium EDTA BP with continuous stirring and check the clarity of solution.
• Add and dissolve Sodium Meta BI Sulphate BP with continuous stirring and check the clarity of solution.
• Add and dissolve Ethamsylate BP with continuous stirring and check the clarity of solution.
• Add and dissolve Propylene Glycol (PG) BP with continuous stirring and check the clarity of solution.
• Check the initial ph (PH RANGE 6.2 TO 6.8) and Adjust pH of bulk solution

with 10% sodium hydroxide/ Hydrochloric Acid (Hcl)solution. and finally make up the volume

with W.F.I and then check the final ph.
• Intimate the IPQA to collect Bulk solution and send to QC for analysis.
5.1 FILTRATION :
• Ensure that Bulk solution Release from QC Department.
• Filter the Bulk solution from Mixing Vessel to Collection Vessel through 0.2 micron sterilized filter.
• Check the Pre and Post Filter Integrity.
5.2 FILL VOLUME DETAILS
• Fill volume for 2 ml Ampoule:
• Standard fill volume -2.1 ml
• Lower fill volume -2.05 ml
• Upper fill volume -2.15 ml

6.0. PRECAUTION :
• Ensure the nitrogen purging throughout the process.
• Always use nose mask, hand gloves while processing.
• All the contact parts of the Equipment, Filtration Assembly , Filling M/C parts & Accessories should be sterilize, at the time of use .

 

7.0. YIELD AND ACCOUNTABILITY :
• Bulk yield (After filtration) between 98 -100 %.
• After Filling, Sealing and visual Inspection completion the % yield is NLT 95%.

 

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