THE WHITE HORSE PHARMACEUTICALS LIMITED

SREEPUR, GAZIPUR, BANGLADESH

R&D DEPARTMENT
Lab Batch Manufacturing Instructions

Name of the product:

Batch No.: Mfg. Date:

Batch Size (Nos): Batch Size (Volume):
Volume Per Phial: Primary Packaging:
Temperature: Humidity:
Potency: Active Source:

Sl Ingredients Specific Quantity Unit Actual Done by Checked by

No. ation per 100 ml Amount per
Batch
1. Fexofenadine HCl BP 0.600 g
2. Glycerin BP 15.000 g

3. Sorbitol 70% liquid BP 30.000 g

4. CMC Sodium BP 0.100 g

5. Avicel RC 591 BP 0.100 g

6. Polysorbate 80 BP 0.150 g

7. Citric Acid BP 0.020 g

Monohydrate
8. Sodium Citrate BP 0.020 g
Dihydrate
9. Sucralose BP 0.800 g

10. Methylparaben Sodium BP 0.150 g

11. Propylparaben Sodium BP 0.020 g

12. Banana Flavor Liquid Ph. Gr 0.100 g

13. Vanilla Flavor Liquid Ph. Gr 0.100 g

14. Purified water BP Q. S to 100 ml

 THE WHITE HORSE PHARMACEUTICALS LIMITED
SREEPUR, GAZIPUR, BANGLADESH

R&D DEPARTMENT

Lab Batch Manufacturing Instructions

Calculation of Raw Materials

NOTES

1. Calculate the quantity of Fexofenadine Hydrochloride as follows :

Theoretical Quantity  100

Quantity of Fexofenadine Hydrochloride = g
Potency

 100
= -------------------- g = ------------------------ g

Calculated by____________________ Checked by ______________________

THE WHITE HORSE PHARMACEUTICALS LIMITED
SREEPUR, GAZIPUR, BANGLADESH

R&D DEPARTMENT

Lab Batch Manufacturing Instructions

METHOD Done by Checked by
 THE WHITE HORSE PHARMACEUTICALS LIMITED
SREEPUR, GAZIPUR, BANGLADESH

R&D DEPARTMENT

1. Transfer g. Sorbitol Solution and g. Glycerin into

the Charge Vat.

2. Take ml Purified water in a Glass Beaker and add

g. CMC Sodium and Avicel RC 591, dissolve them by stirrer for about
3 minutes. Transfer the solution into the Charge Vat with continuous
stirring.
3. Take ml Purified water in a Glass Beaker
and add ______________ g. Polysorbate 80 & _________ g
Fexofenadine HCl dissolves them by stirrer for about 5 minutes.
Transfer the solution into the Charge Vat with continuous stirring.

4. Take ml Purified water in a Glass Beaker and add g.

Citric Acid Monohydrate, dissolve them by stirrer for about 2 minutes.
Transfer the solution into the Charge Vat with continuous stirring.

5. Take ml Purified water in a Glass Beaker and add

g. Sodium Citrate Dihydrate, dissolve them by stirrer for about 3
minutes.
Transfer the solution into the Charge Vat with continuous stirring.

6. Take ml Purified water in a Glass Beaker and add g.

Sucralose, dissolve them by stirrer for about 2 minutes.
Transfer the solution into the Charge Vat with continuous stirring.

7. Take ml Purified water in a Glass Beaker and add

Methylparaben Sodium & Propylparaben Sodium, _________g &
_________g and dissolve them by stirrer for about 2 minutes.
Transfer the solution into the Charge Vat with continuous stirring.

8. Take g. Glycerin in a plastic drum and add

g. Banana & Vanilla flavor and dissolve them by
stirrer for about 5 minutes. Transfer the solution into the Charge Vat
with continuous stirring.

9. Make the volume up to the mark of ml Charge Vat

____________ with Purified water and stir for about 5 minutes.

Lab Batch Manufacturing Instructions

 THE WHITE HORSE PHARMACEUTICALS LIMITED
SREEPUR, GAZIPUR, BANGLADESH

R&D DEPARTMENT
In Process Control
During Bulk Manufacturing

Sl. No Parameter Specification

1. Description: A Homogeneous viscous suspension.

2. pH: 3.00 - 6.50