ESEHI PHARMACEUTICAL INDUSTRIES LIMITED

STANDARD OPERATIONAL PROCEDURE

TITLE Department Production
S.O.P No. EPR-058
Revision No. 00
PRODUCTION PROCESS FOR ESIMOL Effective Date 13/01/2014
SYRUP Supersedes New Introduction
Reviewed Date 13/01/2016
Page Number 1 of 2

1.0 OBJECTIVE
To clearly lay down the procedure for production of Esimol syrup
2.0 SCOPE
This procedure is applicable to all persons working in production department.
3.0 RESPONSIBILITY
3.1 Doing : Production Assistant./Executive
3.2 Checking : Production Pharmacist/Manager
4.0 ACCOUNTABILITY
Head of Department
5.0 PROCEDURE
5.1 Keep the working place neat and clean.
5.2 Follow general instruction laid down by department head.
5.3 Wear appropriate clothing as per S.O.P.
5.4 Follow safety guideline as per instruction given by manufacturers on container
Label.
5.5 Weigh all materials required for the production into clean covered containers as
per Master Formula and label appropriately.
5.6 Heat 100Kg of (PEG 6000) at 50oC in a stainless steel tank and add 25Kg of
Paracetamol in it. Stir the solution for 30 minutes.

PREPARED BY APPROVED BY AUTHORISED BY

NAME MRS EHIGIAMUSOE O. MR. ISIBOR HUMBERT PHARM. OTUTU K.

SIGN.
DATE
 ESEHI PHARMACEUTICAL INDUSTRIES LIMITED
STANDARD OPERATIONAL PROCEDURE
TITLE Department Production
S.O.P No. EPR-058
Revision No. 00
PRODUCTION PROCESS FOR ESIMOL Effective Date 13/01/2014
SYRUP Supersedes New Introduction
Reviewed Date 13/01/2016
Page Number 2 of 2

5.7 Heat 25L of Glycerin at 50oC and then add into step 5.6 solution ((PEG 6000)
+Paracetamol) under continues stirring. Stir the solution for 20 minutes until a
transparent solution is be obtained.
5.8 Heat 300L of D.M water at 50oC and add step 5.7 solution ((PEG 6000)
+Paracetamol+Glycerin) slowly to the D.M. Water under continuous stirring.
Transparent solution will be obtained.
5.9 Weigh accurately 50Kg of sucrose. Add sucrose to 200L of hot (65oC) D.M Water under
continuous stirring till it dissolved.
5.10 Filter above solution through filter press. Keep filtrate under stirring.

5.11 Add 0.7Kg citric acid monohydrate, 2.2Kg Sweetener, 100L sorbitol and 1.5Kg
Sodium benzoate to step 5.10 with continuous stirring for 10 minutes.

5.12 Slowly add step 5.8 solution to step 5.11 under continuous stirring. Stir it till clear
solution is obtained
5.13 Check pH of above solution. If pH is not between 3.80-6.10 then add accordingly
Citric acid solution to adjust pH

5.14 Add 12.52g of carmosine solution into the above solution under stirring. Now, add
2.5L strawberry flavour under continuous stirring and 1.2Kg of Xanthan gum

5.15 Make up volume to 1,000L with de-ionized water and mix for 30 minutes.

5.16 Request Q.A to take sample for analysis and volume verification.

5.17 Await bulk release memo (in-process results) from lab.

5.18 Upon release by Q.A lab, Filter the syrup through the filter press into a holding tank.

5.19 Fill the products into 60ml PET bottles adhering strictly to the volume specifications
(not greater than ± 2%). Stir product regularly in the storage tank as it is being filled.

PREPARED BY APPROVED BY AUTHORISED BY

NAME MRS EHIGIAMUSOE O. MR. ISIBOR HUMBERT PHARM. OTUTU K.

SIGN.
DATE