GLENMARK PHARMACEUTICALS LIMITED

Analytical Research Laboratory (Formulation),Taloja

DCGI BENOC
API / Finished product Specification
Product Name/ Ciclesonide Inhalation Aerosol 80 mcg/actuation (60 Metered Actuations)
Material Name Ciclesonide Inhalation Aerosol 160 mcg/actuation (60 Metered Actuations)
80 mcg/actuation (60 Metered
Actuations)
Strength Status In-house
160 mcg/actuation (60 Metered
Actuations)
Supersedes DEV/SPC/248-00 Effective Date
Specification No DEVSPC/20/001-00 Page No. 1 of 5

Sr.
Tests Specifications
No.
A. For Container and Closure System (External): An aluminum canister
crimped with silver Color ferrule valve, fitted into plastic actuator.
Description B. Check for any physical damage to inhaler device: No visible external
01.
damage, corrosion or leakage should be observed.
For Content of Container (Internal): An aluminum canister contains
clear and colorless liquid..
Moisture
Content (in PPM)
Test to be performed on 1 Canister.
02. (By Coulometric
Limit: Not more than 5000 ppm
titration)

Prepared By Checked By Checked By Approved By

Name
Sign /Date
Designation
Dept. ARF ARF FRD ARF
Format No. FMTHARF080/003.00
 GLENMARK PHARMACEUTICALS LIMITED
Analytical Research Laboratory (Formulation),Taloja
DCGI BENOC
API / Finished product Specification
Product Name/ Ciclesonide Inhalation Aerosol 80 mcg/actuation (60 Metered Actuations)
Material Name Ciclesonide Inhalation Aerosol 160 mcg/actuation (60 Metered Actuations)
80 mcg/actuation (60 Metered
Actuations)
Strength Status In-house
160 mcg/actuation (60 Metered
Actuations)
Supersedes DEV/SPC/248-00 Effective Date
Specification No DEVSPC/20/001-00 Page No. 2 of 5

Strength Content per Content % content

Canister (mg) mg/g. mg/g
80 mcg/act 8.240-12.360 1.344-2.016 80% ─ 120%
Assay (60 Dose)
03. (Content per Inhaler)
(By HPLC) Strength Content per Content mg/g. % content
Canister (mg) mg/g
160 mcg/act 16.160 ─ 24.240 2.641 ─ 3.961 80% ─ 120%
(60 Dose)

Prepared By Checked By Checked By Approved By

Name
Sign /Date
Designation
Dept. ARF ARF FRD ARF
Format No. FMTHARF080/003.00
 GLENMARK PHARMACEUTICALS LIMITED
Analytical Research Laboratory (Formulation),Taloja
DCGI BENOC
API / Finished product Specification
Product Name/ Ciclesonide Inhalation Aerosol 80 mcg/actuation (60 Metered Actuations)
Material Name Ciclesonide Inhalation Aerosol 160 mcg/actuation (60 Metered Actuations)
80 mcg/actuation (60 Metered
Actuations)
Strength Status In-house
160 mcg/actuation (60 Metered
Actuations)
Supersedes DEV/SPC/248-00 Effective Date
Specification No DEVSPC/20/001-00 Page No. 3 of 5

Strength Content per Content mg/g. % content mg/g

Canister (mg) and % Content
per Canister
80 mcg/act 374.512- 61.095-91.642 80% ─ 120%
(60 Dose) 561.768
Ethanol Content
04.
(By GC)
Strength Content per Content mg/g. % content mg/g
Canister (mg) and % Content
per Canister
160 mcg/act 367.240 ─ 60.006 ─ 80% ─ 120%
(60 Dose) 550.860 90.010

Prepared By Checked By Checked By Approved By

Name
Sign /Date
Designation
Dept. ARF ARF FRD ARF
Format No. FMTHARF080/003.00
 GLENMARK PHARMACEUTICALS LIMITED
Analytical Research Laboratory (Formulation),Taloja
DCGI BENOC
API / Finished product Specification
Product Name/ Ciclesonide Inhalation Aerosol 80 mcg/actuation (60 Metered Actuations)
Material Name Ciclesonide Inhalation Aerosol 160 mcg/actuation (60 Metered Actuations)
80 mcg/actuation (60 Metered
Actuations)
Strength Status In-house
160 mcg/actuation (60 Metered
Actuations)
Supersedes DEV/SPC/248-00 Effective Date
Specification No DEVSPC/20/001-00 Page No. 4 of 5

Label Claim:
For 80 mcg/actuation (60 Metered Actuations)

Each 6.1 g canister of Ciclesonide Inhalation Aerosol contains a solution of ciclesonide in propellant HFA-134a
(1,1,1,2 tetrafluoroethane) and ethanol.

Each actuation delivers:

Ciclesonide 100 mcg (Ex-Valve)
Ciclesonide 80 mcg (Ex-Actuator)

160 mcg/actuation (60 Metered Actuations)

Each 6.1 g canister of Ciclesonide Inhalation Aerosol contains a solution of ciclesonide in propellant HFA-134a
(1,1,1,2 tetrafluoroethane) and ethanol.

Each actuation delivers:

Ciclesonide 200 mcg (Ex-Valve)
Ciclesonide 160 mcg (Ex-Actuator)

Note: Follow the current version of standard test procedure no. DEV/STP/239.

Prepared By Checked By Checked By Approved By

Name
Sign /Date
Designation
Dept. ARF ARF FRD ARF
Format No. FMTHARF080/003.00
 GLENMARK PHARMACEUTICALS LIMITED
Analytical Research Laboratory (Formulation),Taloja
DCGI BENOC
API / Finished product Specification
Product Name/ Ciclesonide Inhalation Aerosol 80 mcg/actuation (60 Metered Actuations)
Material Name Ciclesonide Inhalation Aerosol 160 mcg/actuation (60 Metered Actuations)
80 mcg/actuation (60 Metered
Actuations)
Strength Status In-house
160 mcg/actuation (60 Metered
Actuations)
Supersedes DEV/SPC/248-00 Effective Date
Specification No DEVSPC/20/001-00 Page No. 5 of 5

REVISION RECORD
Revision No. Specification No. Date Reason for change
00 DEV/SPC/248-00 14/10/2020 New document

01 DEV/SPC/248-01 1. Assay test has been revised

2.Ethanol Content test has been revised

Prepared By Checked By Checked By Approved By

Name
Sign /Date
Designation
Dept. ARF ARF FRD ARF
Format No. FMTHARF080/003.00