For Area : NMT 5.0%
For RT : NMT 5.0%
hplc or gc analytical method are highly reliable then wet
analytical method. We can analysis even trace amount of
sample with excellent precision,when we use hplc or gc.
stability studies are req. for the product stable at there
desire time a s per specification , which give the expiry
date and quality as per the manner.
milk is slightly acidic in nature .enteric coating provides
protection to the tablet againt acidic environment,so it
does not disintegrate in the stomach and it will pass into
intestine & disintegrate.
edta is contain K3 coated
To get the idea on the process capability that whether the
intended process gives the consistent results or not
under specificity forced degradation study is performed.
specificity is the ability to asses unequally the analyte in
the presence of components which may be expected to be present.
It is performed by following tests.
Heat:At about 105"c for about6 hours.
Humidity:About 90% RH at 25'c for not less than 7 days.
Uv light:Not less than 7 days in uv cabinet or 200 watt
hours or in photostablity chmber.
Sunlight:Not less than 55 hours in sunlight or 1.2million
lux hours in photostability chmber.
Acid:0.1 N HCL reflulxed for 30 minutes at 60"c.
Base:0.1N NAOH refluxed for 30 minutes at 60"c
Peroxide:1% H2O2 refluxed for 30 minutes at 60"c.
Water:refluxed for 6hours at 60"c
information on drug substance- API (DMF)+ EXCIPIENTS
INFORMATION ON FINISHED PRODUCT, MANUFACTURING AND PACKAGING
INFORMATION ON DEVELOPMENT (R&D)
INFORMATION ON STABILITY OF FINISHED PODUCT
Homogenization is intensive blending of mutually related
substances or groups of mutually related substances to form
a constant of different insoluble phases (sometimes with
addition of surfactants) to obtain a suspension or emulsion.
Sonication is the act of applying sound (usually
ultrasound) energy to agitate particles in a sample, for