Exercise No. 08 - Chloramphenicol Palmitate

Download as docx
Download as docx
You are on page 1of 5

Name __________________________ Date ___________________

Section ______________ Group No. ______________


Exercise No. 8
----------------------------------------------------------------
M.O. #____________
MARY IMMACULATE PHARMACY
Fr. Selga St.
Davao City

MANUFACTURING ORDER

Product: CHLORAMPHENICOL PALMITATE Manufacturing:

Batch Size______________ Date Started____________

Batch Number____________ Date Finished___________

Expiry Date_____________

----------------------------------------------------------------
Control Item Ingredients Amount per X –
numbers Code # 120 liters
_______ ______ Chloramphenicol
Palmitate 5 kg ________
_______ ______ Carboxymethyl 1 kg ________
Cellulose Na
_______ ______ Methyl Paraben Na 240 g ________
_______ ______ Propyl Paraben Na 60 g ________
_______ ______ Tween 20 120 ml ________
_______ ______ Sugar 60 kg ________
_______ ______ Sodium Citrate 120 g ________
_______ ______ Citric Acid 220 g ________
_______ ______ Raspberry Flavour 220 g ________
_______ ______ Glycerin 2.5 lit. ________
_______ ______ Purified Water q.s. 120 lit. ________
----------------------------------------------------------------

Manufacturing Specifications:

1. Use 60 ml Amber Glass Bottles.


2. PH should be between 4.5 and 7.0.
3. 174 mg of Chloramphenicol Palmitate is equivalent to 100 mg
of Chloramphenicol.

Prepared by __________________ Approved by _________________


Date ________________________ Date ________________________

1
MARY IMMACULATE PHARMACY
Fr. Selga St.
Davao City

MANUFACTURING BATCH RECORD

Product: CHLORAMPHENICOL PALMITATE


ORAL SUSPENSION Manufacturing:

Batch Size __________________ Date Started ______________

Batch Number ________________ Date Finished _____________

Expiry Date _________________

I. SOP PRIOR BATCH PROCESSING

1. All ingredients must be checked and approved by Q.C. Prior


to use.
2. All ingredients must be labeled properly. Weights and
volume must agree with the approved M.O.
3. All equipment and accessories must be cleaned.
4. Processing room must be cleaned.
5. Wear necessary protective garments.

II.CLEAN ROOM AND EQUIPMENT CHECK:


Cleaned by Checked by

Liquid Manufacturing Room ---------- ---------


Required Equipment ---------- ---------

III.MANUFACTURING PROCEDURE:

A. 1. Heat 30 lit. (________) of Purified Water to 60°C in a SS


vessel and dissolve Methyl Paraben Sodium and Propyl
Paraben Sodium (half quantity).
By _____________________ Checked by
________________

2. Add 60 kg (________) sugar under constant stirring and


raise the temperature to boiling point.

By ____________________ Checked by _________________

3. Add Citric Acid and Sodium Citrate to the hot syrup and
filter.

2
By ____________________ Checked by _________________
Product: CHLORAMPHENICOL PALMITATE Batch Size ___________
ORAL SUSPENSION Batch NO._____________
---------------------------------------------------------------
4. Allow to cool to room temperature by keeping it overnight.

By ____________________ Checked by _________________

B. 1. Mix Glycerin with CMC solution in an SS vessel to form a


smooth paste.

By ____________________ Checked by _________________

2. Add Tween 80 and again stir well to form a thin paste.

By ____________________ Checked by _________________

3. To a SS tank, transfer 50 lit. (_______) of filtered water


and heat to 60°C.

By ____________________ Checked by _________________

4. Dissolve Methyl Paraben Sodium and Propyl Paraben Sodium


(half quantity).

By ____________________ Checked by _________________

5. Add 100 g (________) Citric acid and 60 g (_________)


Sodium Citrate and stir till completely dissolved.

By ____________________ Checked by _________________

6. To this hot water solution add the Glycerin-CMC Sodium-


Tween 80 paste slowly under constant stirring. Continue
till completely dissolved. Allow to cool to room
temperature.
By ____________________ Checked by _________________

C. 1. Start stirring the mixture of Step B. In case the jelly is


thick and does not move add more quantity of filtered syrup
from Step A and water till the whole mass is moving with the
stirrer.
By ____________________ Checked by _________________
2. To this mass add Chloramphenicol Palmitate in small
quantities and suspend uniformly.
By ____________________ Checked by _________________

3
Product: CHLORAMPHENICOL PALMITATE Batch Size ___________
ORAL SUSPENSION Batch NO._____________
---------------------------------------------------------------

3. Add the syrup from step A along with Chloramphenicol


Palmitate and Purified Water.

By _____________________ Checked by _________________

4. Continue stirring and make up the volume.

By _____________________ Checked by _________________

5. Allow to stand overnight.

By _____________________ Checked by _________________

6. Check the volume and adjust.

By __________________ Checked by _________________

7. Add Raspberry Essence and stir thoroughly.

By __________________ Checked by _________________

IV. BARCH SAMPLING: (Show Computation)

Sample Size _________________

Sample by ___________________

Date ____________________
Time ____________________

Results _____________________
______________________
______________________

Verified by ________________

Disposition ________________

4
V. BATCH RECONCILIATION (show Computation)

Sample _____________ (__________ %)

Net Yield __________ (__________ %)

Gross Yield ________ (__________ %)

Loss/ Overage ______ (__________ %)

COMPUTATION:

Give the role of each ingredients in the formulation:

Ingredients Role of Ingredients


Chloramphenicol Palmitate _____________________________

Carboxylmethyl Cellulose Na _____________________________

Methyl Paraben Na _____________________________

Propyl Paraben Na _____________________________

Tween 20 _____________________________

Sugar _____________________________

Sodium Citrate _____________________________

Citric Acid _____________________________

Raspberry Flavour _____________________________

Glycerin _____________________________

Purified Water q.s. _____________________________


5

You might also like