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The following specifications in Table 1 and Table 2 will apply at the time of lot release and at shelf life to CONCERTA( 18 mg, 27 mg, 36 mg and 54 mg Prolonged Release Tablets.



|Table 1:CONCERTA(lot release and shelf-life specifications |
|Test Parameter|Acceptance Criteria |Method |
|1. Appearance ||Visual |
|18 mg |Yellow capsule-shaped tablet printed with ‘alza 18’. | |
|27 mg|Gray capsule-shaped tablet printed with ‘alza 27’. | |
|36 mg |White capsule-shapedtablet printed with ‘alza 36’. | |
|54 mg |Brownish-red capsule-shaped tablet printed with ‘alza 54’. ||
|2. Identification | | | |
|HPLC|HPLC retention time matches reference standard with +/- 5 % |USP |
|FTIR |Concordant with reference spectrum|USP |
|3. Water Content |≤ 3 % |In-House|
|4. Uniformity of Dosage Units |USP, L1 acceptance value ≤15.0 and L2≤ 25.0 |USP |
|5. Release Rate |...