Response to Day - 75 Comments:PT/H/0403/ /E/ P DRUG PRODUCT ESCITALOPRAM TABLETS

Transcription

1 3.2.P DRUG PRODUCT ESCITALOPRAM TABLETS

2 ANNEXURE P.5.1 AMENDED SECTION FOR DRUG PRODUCT SPECIFICATION

3 3.2.P.5 CONTROL OF DRUG PRODUCT (Escitalopram 5mg, 10mg, 15mg & 20mg Tablets). 3.2.P.5.1 SPECIFICATIONS (Escitalopram 5mg, 10mg, 15mg & 20mg Tablets) The following specifications of Escitalopram Tablets are presented in this section: 1) Release and Shelf life specifications of Escitalopram 5mg Tablets 2) Release and Shelf life specifications of Escitalopram 10mg Tablets 3) Release and Shelf life specifications of Escitalopram 15mg Tablets 4) Release and Shelf life specifications of Escitalopram 20mg Tablets Page 1

4 PROPOSED & SHELF LIFE SPECIFICATIONS OF ESCITALOPRAM 5mg TABLETS 1. Description White to off white colored, round shaped, film-coated, biconvex tablets debossed with F on one side and 53 on the other side. exhibit maxima at the same wavelength as that of Escitalopram oxalate working standard solution. 3. Average Weight (Mass) (mg) ± 5.0% ( ) 5. Uniformity of Dosage units (By Content Uniformity) 6. Water (% m/m, By KF) Not more than Related Substances (% m/m, By HPLC) # 8. Assay (By HPLC): Each film-coated tablet contains Escitalopram oxalate equivalent to Escitalopram In mg Thickness (mm) 2.80 ± 0.30 ( ) Isopropyl Alcohol (µg/g, By GC) Not more than Content of Butylated Hydroxy Anisole - Added amount (mg/tablet) Not less than Not less than Content of Butylated Hydroxy Toluene - Added amount (mg/tablet) Not less than Not less than Microbial Contamination * 14. Identification of Titanium dioxide * Yellow / Red colour should be produced with hydrogen * During release, the tests for Identification of Microbial contamination and Titanium dioxide shall be performed on non-routine basis and will be carried out in the first three commercial batches manufactured by Aurobindo Pharma Limited and there after on every 10 th commercial batch or one batch per year, whichever is earlier. Page 2

5 PROPOSED & SHELF LIFE SPECIFICATIONS OF ESCITALOPRAM 10mg TABLETS 1. Description White to off white colored, oval shaped, film-coated, biconvex tablets debossed with F on one side and 54 on the other side with a deep scoreline between 5 and 4. exhibit maxima at the same wavelength as that of Escitalopram oxalate working standard solution. 3. Average Weight (Mass) (mg) ± 4.0% ( ) 5. Subdivision of Tablets * (Uniformity of Mass for split halves) Should meet the current Ph.Eur. requirements. 6. Uniformity of Dosage units (By Content Uniformity) 7. Water (%m/m, By KF) Not more than Related Substances (% m/m, By HPLC) # 9. Assay (By HPLC): Each film-coated tablet contains Escitalopram oxalate equivalent to Escitalopram In mg Thickness (mm) 3.60 ± 0.30 ( ) Isopropyl Alcohol (µg/g, By GC) Not more than Content of Butylated Hydroxy Anisole - Added amount (mg/tablet) Not less than Not less than Content of Butylated Hydroxy Toluene - Added amount (mg/tablet) Not less than Not less than Microbial Contamination * 15. Identification of Titanium dioxide * Yellow / Red colour should be produced with hydrogen * During release, the tests for Subdivision of Tablets, Microbial contamination and Identification of Titanium dioxide shall be performed on non-routine basis and will be carried out in the first three commercial batches manufactured by Aurobindo Pharma Limited and there after on every 10 th commercial batch or one batch per year, whichever is earlier. Page 3

6 PROPOSED & SHELF LIFE SPECIFICATIONS OF ESCITALOPRAM 15mg TABLETS 1. Description White to off white colored, oval shaped, film-coated, biconvex tablets debossed with F on one side and 55 on the other side with a deep scoreline between 5 and 5. exhibit maxima at the same wavelength as that of Escitalopram oxalate working standard solution. 3. Average Weight (Mass) (mg) ± 4.0% ( ) 5. Subdivision of Tablets * (Uniformity of Mass for split halves) Should meet the current Ph.Eur. requirements. 6. Uniformity of Dosage units (By Content Uniformity) 7. Water (%m/m, By KF) Not more than Related Substances (% m/m, By HPLC) # 9. Assay (By HPLC): Each film-coated tablet contains Escitalopram oxalate equivalent to Escitalopram In mg Thickness (mm) 4.00 ± 0.30 ( ) Isopropyl Alcohol (µg/g, By GC) Not more than Content of Butylated Hydroxy Anisole - Added amount (mg/tablet) Not less than Not less than Content of Butylated Hydroxy Toluene - Added amount (mg/tablet) Not less than Not less than Microbial Contamination * 15. Identification of Titanium dioxide * Yellow / Red colour should be produced with hydrogen * During release, the tests for Subdivision of Tablets, Microbial contamination and Identification of Titanium dioxide shall be performed on non-routine basis and will be carried out in the first three commercial batches manufactured by Aurobindo Pharma Limited and there after on every 10 th commercial batch or one batch per year, whichever is earlier. Page 4

7 PROPOSED & SHELF LIFE SPECIFICATIONS OF ESCITALOPRAM 20mg TABLETS 1. Description White to off white colored, oval shaped, film-coated, biconvex tablets debossed with F on one side and 56 on the other side with a deep scoreline between 5 and 6. exhibit maxima at the same wavelength as that of Escitalopram oxalate working standard solution. 3. Average Weight (Mass) (mg) ± 3.0% ( ) 5. Subdivision of Tablets * (Uniformity of Mass for split halves) Should meet the current Ph.Eur. requirements. 6. Uniformity of Dosage units (By Content Uniformity) 7. Water (%m/m, By KF) Not more than Related Substances (% m/m, By HPLC) # 9. Assay (By HPLC): Each film-coated tablet contains Escitalopram oxalate equivalent to Escitalopram In mg Thickness (mm) 4.30 ± 0.30 ( ) Isopropyl Alcohol (µg/g, By GC) Not more than Content of Butylated Hydroxy Anisole - Added amount (mg/tablet) Not less than Not less than Content of Butylated Hydroxy Toluene - Added amount (mg/tablet) Not less than Not less than Microbial Contamination * 15. Identification of Titanium dioxide * Yellow / Red colour should be produced with hydrogen * During release, the tests for Subdivision of Tablets, Microbial contamination and Identification of Titanium dioxide shall be performed on non-routine basis and will be carried out in the first three commercial batches manufactured by Aurobindo Pharma Limited and there after on every 10 th commercial batch or one batch per year, whichever is earlier. Page 5