QUALITY CONTROL

Document code: Issue status: Effective date:

Page 1 of 2
QP/QC/02/WI-A001 01 07-07-2007
DOCUMENT TITLE:
STANDARD ANALYTICAL PROCEDURE
FOR
AMINOPHYLLINE

PURPOSE & SCOPE:

It is established for chemical analysis of AMINOPHYLLINE is applicable to Quality Control department.

RESPONSIBILITY:
1. Manager Quality Control.
2. Assistant Manager Quality Control.
3. Quality Control Analyst.

DESCRIPTION:
Appearance: A white or slightly yellowish powder, sometimes granular.
Solubility: Freely soluble in water (the solution becomes cloudy through absorption of carbon dioxide), practically insoluble in
ethanol.

C16H24N10O4 420.4

IDENTIFICATION:
1) Dissolve 1.0 g in 10 ml of water R and add 2 ml of dilute hydrochloric acid R drop wise with shaking. Filter. The
precipitate, washed with water R and dried at 100°C to 105°C, melts at 270°C to 274°C.

TESTS:
1) Water: Not more than 1.5 per cent, determined on 2.00 g dissolved in 20 ml of anhydrous pyridine R, by the semi-micro
determination of water.

ASSAY:
Ethylenediamine: Dissolve 0.250 g in 30 ml of water. Add 0.1 ml of bromocresol green solution R. Titrate with 0.1M hydrochloric
acid until a green colour is obtained.
Each ml of 0.1M hydrochloric acid is equivalent to 3.005 mg of Ethylenediamine.
Prepared by: Reviewed by: Approved by:
 QUALITY CONTROL
Document code: Issue status: Effective date:
Page 2 of 2
QP/QC/02/WI-A001 01 07-07-2007
DOCUMENT TITLE:
STANDARD ANALYTICAL PROCEDURE
FOR
AMINOPHYLLINE

Limit: 13.5 ~ 15 %

Theophylline: Heat 0.200 g to constant mass in an oven at 135°C. Dissolve the residue with heating in 100 ml of water, allow to cool,
add 20 ml of 0.1M silver nitrate and shake. Add 1 ml of bromothymol blue solution R1. Titrate with 0.1M sodium hydroxide.
Each ml of 0.1Msodium hydroxide is equivalent to 18.02 mg of Theophylline.
Limit: 84 ~ 87.4 %

RELATED DOCUMENTS
S.No Document Title Document Code S.No Document Title Document Code
Request for Sampling of Raw Q.C Analysis Certificate for Raw
1 QF/STR/001 4 QF/QC/003
Material. Material.
2 Raw Material Entry Register QF/QC/006 5 “Approved Raw Material” slip QF/QC/009
3 Analysis Record for Raw Materials QF/QC/017 6 “Rejected Raw Material” slip QF/QC/011

Prepared by: Reviewed by: Approved by: