Final Test of HPMC Capsule Shells

Dimension of capsules are controlled to ensure conformance to specifications.

Description Cylindrical, Opaque, Telescopic Capsules I.P.
Identification The smoke of burned capsule smells like burning woodchip or paper I.P.
Odour No Foreign Odour I.P.
Disintegration Time in 0.1N HCl at 37 + 1 °C Less Than 15 Minutes I.P.
Loss on Drying 3.0-8.0 % I.P. / USP
pH ( 1% aq solution) 5.0-7.0 IHT
Heavy Metals < 0.001% I.P.
Arsenic <3 ppm I.P.
Self Locking Feature Shell and body lock together and are not readily separated. IHT
Brittleness Shell deforms under pressure but does not crack IHT
Microbiological Test
Total Bacterial Count Less Than 1000 cfu / gm I.P. / USP
Escherichia Coli Absent in 10 gms I.P. / USP
Salmonella Absent in 10 gms I.P. / USP
Staphylococcus Aureus Absent in 10 gms I.P. / USP
Pseudomonas Absent in 10 gms I.P. / USP
Clostridium Spec. Absent in 10 gms I.P. / USP
Yeast and Moulds Below 100 cfu/ gm I.P. / USP