Packaging and storage—
Preserve in tight containers.
Identification—
Place a portion of powdered Tablets, equivalent to about 100 mg of methylphenidate hydrochloride, in a 100-mL beaker. Add 20 mL of chloroform, stir for 5 minutes, and filter, collecting the filtrate. Evaporate the filtrate to about 5 mL. Add ethyl ether slowly, with stirring, until crystals form. Filter the crystals, wash with ethyl ether, and dry at 80
for 30 minutes: the IR absorption spectrum of a mineral oil dispersion of the crystals so obtained exhibits maxima only at the same wavelengths as that of a similar preparation of
USP Methylphenidate Hydrochloride RS.
Drug release 
724
—
Medium:
water; 500 mL.
Apparatus 2:
50 rpm.
Times:
1, 2, 3.5, 5, and 7 hours.
Test solution—
Use portions of the solution under test passed through a 0.45-µm polypropylene filter. [Note—Do not use glass fiber filters.]
Procedure—
Determine the amount of C14H19NO2·HCl dissolved, employing the procedure set forth in the Assay, making any necessary volumetric adjustments.
Tolerances—
The percentages of the labeled amount of C
14H
19NO
2·HCl dissolved at the times specified conform to
Acceptance Table 1.
| Time (hours) |
 Amount dissolved |
| 1 |
between 25% and 45% |
| 2 |
between 40% and 65% |
| 3.5 |
between 55% and 80% |
| 5 |
between 70% and 90% |
| 7 |
not less than 80% |
Dissolution 711—
Medium:
water; 500 mL.
Apparatus 2:
50 rpm.
Times:
1, 2, 3.5, 5, and 7 hours.
Test solution—
Use portions of the solution under test passed through a 0.45-µm polypropylene filter. [Note—Do not use glass fiber filters.]
Procedure—
Determine the amount of C
14H
19NO
2·HCl dissolved, employing the procedure set forth in the
Assay, making any necessary volumetric adjustments.
Tolerances—
The percentages of the labeled amount of C
14H
19NO
2·HCl dissolved at the times specified conform to
Acceptance Table 2.
| Time (hours) |
Amount dissolved |
| 1 |
between 25% and 45% |
| 2 |
between 40% and 65% |
| 3.5 |
between 55% and 80% |
| 5 |
between 70% and 90% |
| 7 |
not less than 80% |
(Official April 1, 2006)
Auxiliary Information—
Staff Liaison :
Ravi Ravichandran, Ph.D., Senior Scientist
Expert Committee : (MDPP05) Monograph Development-Psychiatrics and Psychoactives
USP29–NF24 Page 1406
Pharmacopeial Forum : Volume No. 31(1) Page 164
Phone Number : 1-301-816-8330
