Stability of Betaine Capsules

Table 3

Content assay and dissolution of the betaine capsules.

	Initial; (mg)	1 month; (%)	2 months; (%)	3 months; (%)	6 months; (%)	9 months; (%)	12 months; (%)
22°C—ambient RH—vials
160 mg	167±4	NT	NT	102.5±1.6	F	F	F
625 mg	650±6	NT	NT	100.5±1.5	F	F	F
30°C—65% RH—vials
160 mg	167±4	NT	NT	F	F	F	F
625 mg	650±6	NT	NT	F	F	F	F
40°C—75% RH—vials
160 mg	167±4	F	F	F	F	F	F
625 mg	650±6	F	F	F	F	F	F
22°C—ambient RH—bags
160 mg	167±4	NT	NT	102.2±5.8	96.7±3.3	94.3±0.1^∗	93.4±0.4^∗
625 mg	650±6	NT	NT	98.3±1.9	103.2±0.7	98.2±0.8	96.9±0.5
30°C—65% RH—bags
160 mg	167±4	NT	NT	102.1±4.0	F	F	F
625 mg	650±6	NT	NT	100.6±1.1	100.0±0.5	F	F
40°C—75% RH—Bags
160 mg	167±4	F	F	F	F	F	F
625 mg	650±6	98.2±2.2	100.1±1.6	F	F	F	F

Initial results are reported in mg/capsule; stability results are reported as percentage of initial value; unless otherwise noted, all capsules completely dissolved within 15 min; *for 1 capsule out of 3×6 replicates, a few undissolved particulate fragments remained after 15 min and these fragments completely dissolved within 30 min. The 15 min release was not less than 85%; F: failed visual examination; NT: not tested.