Assay for potency

效价分析

Specific methods where possible should be used

如有可能应使用专属性方法

A bracketing approach may be used for multiple strengths

对于不同规格可使用括号法

At each site:

每个实验室：

2 analysts × 3 lots, in triplicate (= 18 per site)

2分析师× 3批，重复三次（每个实验室18次）

Different sets

of instruments and columns

不同的仪器和柱组合

Independent solution preparation

独立的溶液配制

Comparison of mean and variability

比较平均值和偏差

Two one sided t-tests with inter-site differences ≤2% , 95% confidence

双单侧t检验，实验室间差异≤2% @95%置信度

Content

Uniformity

含量均匀性

If method is equivalent to assay method, separate transfer is not  usually required

如果该方法与含量测定方法等同，则通常不需要分别

转移

At each site:

每个实验室：

2 analysts, × 1 lot (= 2 per site)

2分析师×1批（=每个实验室2次）

Different sets of instruments and columns

不同的仪器和柱组合

Independent solution preparation

独立的溶液配制

Mean at RU within ± 3% of mean at SU;

接收方的平均值在转移方平均值的±3%以内

comparison of relative standard deviation

比较相对标准偏差

Two one sided t-tests with inter-site differences ≤ 3% , 95% confidence

双单侧t检验，实验室间差异≤3% @95%置信度

Dissolution

溶出度

Bracketing may

be appropriate for multiple strengths

对于不同规格可使用括号法

6 units (12, if not routine at RU, and for extended release products)

6个单位(12个，如接收方不作为常规测试，和延长放行产品)

Mean at RU within ± 5% of mean at SU

接收方的平均值在转移方平均值的±5%

Compare profile (e.g. F2), or compare data at Q time points, as for  assay

比较资料(如F2)，或比较Q时间点的数据