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. Ondansetron HCl BP 0.0995 g
2. Glycerin BP 10.000 g

3. Sorbitol 70% Liquid BP 25.000 g

4. Citric Acid BP 0.350 g

Monohydrate
5. Sodium Citrate BP 0.400 g

6. Sucralose BP 0.150 g

7. Methylparaben Sodium BP 0.100 g

8. Propylparaben Sodium BP 0.020 g

9. Vanilla Flavor Ph. Gr 0.050 g

10. Strawberry Flavor Ph. Gr 0.200 g

11. 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 Ondansetron HCl as follows :

Theoretical Quantity  100

Quantity of Ondansetron HCl = 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

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

the Charge Vat.

2. Take ml Purified water in a Glass Beaker

and add ______________ g. Ondansetron HCl and dissolve
them by stirrer for about 5 minutes. Transfer the solution into the
Charge Vat with continuous stirring.
3. 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.

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

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

5. 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.

6. 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.

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

Yellow Color _________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 Glass Beaker and add

g. Vanilla Flavor & Strawberry 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.
 THE WHITE HORSE PHARMACEUTICALS LIMITED
SREEPUR, GAZIPUR, BANGLADESH

R&D DEPARTMENT

Lab Batch Manufacturing Instructions

In Process Control
During Bulk Manufacturing

Sl. No Parameter Specification

1. Description: Yellow color clear solution.

2. pH: 3.50 – 6.0