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Dissolution a <6.10> Perform the test with an accurately weighed quantity of Diazepam Powder,

equivalent to about 10 mg of diazepam (C 16 H13 ClN2 O) according to the labeled amount, at 100
revolutions per minute according to the Paddle method, using 900 mL of water as the dissolution
medium.

Withdraw not less than 20 mL of the medium at the specified minute after starting the test,
and filter through a membrane filter with a pore size not exceeding 0.45 μm.

Discard the first 10 mL of
the filtrate, and use the subsequent filtrate as the sample solution.

Separately, weigh accurately about 22
mg of Diazepam RS, previously dried at 105ºC for 2 hours, and dissolve in ethanol (95) to make
exactly 100 mL.

Pipet 5 mL of this solution, add water to make exactly 100 mL, and use this solution
as the standard solution.

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Determine the absorbances, AT and AS, of the sample solution and standard

solution at 230 nm as directed under Ultraviolet-visible Spectrophotometry <2.24>, using water as the
blank.

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The requirements are met if Diazepam Powder conforms to the dissolution requirements.

Dissolution rate (%) with respect to the labeled amount of diazepam (C16 H13 ClN2 O)
= MS/MT ×AT/AS ×1/C × 45

MS: Amount (mg) of Diazepam RS
MT: Amount (g) of sample

C: Labeled amount (mg) of diazepam (C 16 H13 ClN2 O) in 1 g
Dissolution Requirements a

Labeled amount Specified minute Dissolution rate

10 mg/g 120 minutes Not less than 70%
Dissolution b <6.10>

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Perform the test with an accurately weighed quantity of Diazepam Powder,

equivalent to about 10 mg of diazepam (C16 H13 ClN2 O) according to the labeled amount, at 75

revolutions per minute according to the Paddle method, using 900 mL of water as the dissolution

medium.

Withdraw not less than 20 mL of the medium at the specified minute after starting the testand filter through a

membrane filter with a pore size not exceeding 0.45 μm. Discard the first 10 mL of

the filtrate, pipet 2 mL of the subsequent filtrate, add water to make exactly 10 mL, and use this

solution as the sample solution. Separately, weigh accurately about 22 mg of Diazepam RS, previously

dried at 105ºC for 2 hours, and dissolve in ethanol (95) to make exactly 100 mL. Pipet 2 mL of this
solution, add water to make exactly 200 mL, and use this solution as the standard solution. Determine

the absorbances, AT and AS, of the sample solution and standard solution at 230 nm as directed under