8/14/2019 Exercise No. 07 - Guiaphenesin Elixir 2%

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Name _______________________ Date ____________________Section ____________________ Group No. _______________

Exercise NO. 7----------------------------------------------------------------

M.O. # __________

MARY IMMACULATE PHARMACYFr. Selga St.Davao City

MANUFACTURING ORDER

Product: GUAIPHENESIN ELIXIR 2% Manufacturing:

Batch Size _________________ Date Started ______________

Batch Number _______________ Date Finished _____________

Expiry Date ________________----------------------------------------------------------------Control Item Ingredients Amount per X Number Code # 1000 liters

_______ ______ Guaiphenesin USP 20 kg ________________ ______ Alcohol 95% USP 42.105 lit. ________________ ______ Methyl Paraben NF 1 kg ________________ ______ Propyl Paraben NF 100 g _________

_______ ______ Orange Flavor 40 lit. ________________ ______ Glycerin USP(sp. gr. 1.249) 450 lit. _________

_______ ______ Sucrose 127.5 kg ________________ ______ FD&C Yellow # 6 500 g ________________ ______ Purified Water,

q.s. 1000 liters ________________ ______ 1N Hydrochloric Acid_______ ______ 2N Sodium Hydroxide

( to adjust pH to 3.0 to 4.0)_______ ______ ALSOP filter Pads----------------------------------------------------------------Manufacturing Specifications:

1. pH Range = 3.5 to 4.02. Use 60 ml Amber Glass Bottle with 25 mm PP caps.

Prepared by _______________ Approved by ___________________Date ______________________ Date __________________________

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MARY IMMACULATE PHARMACYFr. Selga St.Davao City

MANUFACTURING BATCH RECORD

Product: GUIAPHENESIN ELIXIR 2% Manufacturing:

Batch Size ________________ Date Started ___________

Batch Number______________ Date Finished __________

Expiry Date_______________

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I. SOP PRIOR TO BATCH PROCESSING

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

2. All ingredients must be labeled properly. Weights andvolume 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

1. Pour 300 liters (_______) of Purified Water into astainless steel container and heat to 60C (140F).By __________________ Checked by ________________

2. Dissolve Methyl Paraben NF and Propyl Paraben NF inPurified Water and heat to 80C (176F) under stirring for15 minutes. Check visually for complete solution of the

parabens.By __________________ Checked by ________________

3. Cool the mixture to 65C (149F) under stirring. Then addGuiaphenesin USP, Sucrose NF, and Glycerin USP one by oneunder constant stirring until homogenous and cool to 30C.

By __________________ Checked by ________________

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Product: GUAIPHENESIN ELIXIR 2% Batch Size______ Batch No.______________________________________________________________________

V. BATCH RECONCILIATION (Show Computation)

Sample _______________ (___________ %)

Net Yield ____________ (___________ %)

Gross Yield __________ (___________ %)

Loss/ Overage ________ (___________ %)

Computation:

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Role of ingredients in the formulation:

Ingredients Role of Ingredients

Guaiphenesin USP __________________________________

Alcohol 95% USP __________________________________

Methyl Paraben NF __________________________________

Propyl Paraben NF __________________________________

Orange Flavor __________________________________

Glycerin USP __________________________________

Sucrose __________________________________

FD&C Yellow # 6 __________________________________

Purified Water,q.s. __________________________________

1N Hydrochloric Acid __________________________________

2N Sodium Hydroxide __________________________________

ALSOP filter Pads __________________________________

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