辅酶Q10片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号2306201对照品来源原料药对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数10000
标示量(mg)10供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.931110441112411110121109981108711110330.13
210.911099951099071099510.06
单位质量响应值RSD%判断
10158.5510078.000.57数据可信
供试品溶液-24042402批-含5%曲拉通X-100和1%吐温80的水溶液
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min12635-26352.3322.1115.652.332.1115.67
21958-19581.7331.73
32570-25702.2752.27
10min16947-69476.1485.975.716.165.985.76
26299-62995.5755.58
36983-69836.1806.19
15min19939-99398.7968.802.878.848.842.89
29658-96588.5488.59
310229-102299.0539.10
30min118776-1877616.61816.711.9516.7116.801.97
218576-1857616.44116.53
319288-1928817.07117.17
45min124322-2432221.52622.162.5721.7122.352.55
225263-2526322.35922.54
325547-2554722.61022.80
60min128760-2876025.45426.814.5625.7627.124.53
230699-3069927.17027.47
331433-3143327.82028.14
90min138452-3845234.03234.902.5734.4835.362.55
240476-4047635.82336.28
339384-3938434.85735.33
120min145081-4508139.89940.581.4540.5441.231.46
246237-4623740.92241.58
346226-4622640.91241.58
240min160628-6062853.65956.824.8354.5257.704.78
265859-6585958.28859.17
366117-6611758.51759.41
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
360min172981-7298164.59266.352.3065.7567.552.31
275991-7599167.25668.46
375940-7594067.21068.43
极限172966-7296664.57866.712.8266.1068.272.80
276958-7695868.11169.69
376192-7619267.43369.03
辅酶Q10片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号2306201对照品来源原料药对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数10000
标示量(mg)10供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.931104231101871103861104531103431103580.10
210.911095961097461096710.10
单位质量响应值RSD%判断
10096.8010052.340.32数据可信
供试品溶液-236B11S批
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min12393-23932.1272.006.832.132.006.77
22254-22542.0042.00
32087-20871.8551.86
10min15714-57145.0794.943.685.094.953.71
25619-56194.9955.01
35322-53224.7314.74
15min19529-95298.4708.223.548.518.263.52
29320-93208.2848.32
38888-88887.9007.94
30min117097-1709715.19715.130.6415.2815.210.65
217076-1707615.17815.26
316899-1689915.02115.10
45min121987-2198719.54419.992.0319.7220.162.00
222879-2287920.33720.51
322601-2260120.08920.25
60min126362-2636223.43324.223.3623.7124.503.33
228191-2819125.05825.34
327204-2720424.18124.46
90min134421-3442130.59630.870.7931.0131.280.78
234934-3493431.05231.47
334831-3483130.96031.37
120min139686-3968635.27635.881.5135.8636.471.50
240842-4084236.30336.90
340584-4058436.07436.66
240min151916-5191646.14747.863.1346.9248.643.10
255044-5504448.92749.72
354561-5456148.49849.28
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
360min163012-6301256.01056.250.9957.0457.300.97
262834-6283455.85256.92
363989-6398956.87857.93
极限161522-6152254.68555.841.8056.0357.201.78
263547-6354756.48557.86
363384-6338456.34157.71
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