25 Caffeine
25 Caffeine
25 Caffeine
0 Purpose:-
To provide a system for monitoring and measurement of Raw Materials and to ensure that the Raw
Material conforms to the requirements of the defined Raw Material Specifications.
2.0 Scope:-
This procedure is applicable to the testing of Caffeine anhydrous only.
3.0 Responsibility:-
3.1. Quality Control Manager is responsible for implementation of this procedure.
3.2. Assistant Quality Control Manager and Quality Control Analyst are responsible for practicing
this procedure.
4.0 HSE Requirements :-
4.1. Wear safety masks, goggles and rubber gloves where necessary.
4.2. Hand over wastes separately to sanitation section for safe disposal.
4.3. To follow the safety rules and regulation according to procedure # QCD/QSP/002
4.4. Store and handle the hazardous material according to procedure # QCD/QSP/005
4.5. Handle the spillage material according to procedure # QCD/QSP/003
5.0 Procedure:-
5.1. Instrument:
5.1.1. UV Spectrophotometer.
5.1.2. Analytical Weighing Balance.
5.1.3. Melting Point Apparatus
5.1.4. FTIR
5.1.5. Oven
C8H10N4O2 194.2
5.4. Identification:
Infrared Absorption: The Infrared absorption spectrum of the sample corresponds to the
reference spectrum of working standard of Caffeine Anhydrous.
Melting Point: 2340 C to 2390 C.
Ultraviolet Absorption: The UV-Visible absorption spectrum (scanned between 200nm and
320nm) of sample solution corresponds to the reference spectrum of Caffeine working
standard as prepared for assay.
5.5. Loss on Drying: Not more than 0.5 per cent, determined on 1.000 g by drying in an oven at
800 C for 4 hrs.
5.6. Assay:
5.6.1. Sample preparation: Dissolve 50.0mg of Caffeine sample in water and dilute to
100ml with the same solvent. Dilute 2ml of the resultant solution to 100ml with water.
5.6.2. Standard preparation: Dissolve 50.0mg of Caffeine standard in water and dilute to
100ml with the same solvent. Dilute 2ml of the resultant solution to 100ml with water.
Measure the absorbance of both sample and standard solution at 273nm using water
as a blank.
where;
As = Absorbance of sample solution.
Ar = Absorbance of standard solution.
Wr = Weight of standard in mg.
Ws = Weight of sample in mg.
LOD = Loss on drying (%).
P = Percentage Purity of standard on as is basis