辅酶Q10片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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%
110.882884842890952882782884132881472884830.13
210.792897422896632897020.02
单位质量响应值RSD%判断
26514.9826849.120.89数据可信
供试品溶液-24110101批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min178369-7836926.30326.934.1926.3026.934.19
277686-7768626.07426.07
382407-8240727.65827.66
476818-7681825.78325.78
580430-8043026.99526.99
685698-8569828.76328.76
10min199426-9942633.37133.622.7633.4133.672.76
297092-9709232.58732.63
3102167-10216734.29134.34
498904-9890433.19533.24
598795-9879533.15933.20
6104707-10470735.14335.19
15min1112611-11261137.79637.852.3637.9037.952.36
2110164-11016436.97537.07
3113623-11362338.13638.24
4111393-11139337.38737.49
5111210-11121037.32637.43
6117597-11759739.46939.58
20min1122352-12235241.06541.011.8541.2341.181.84
2118723-11872339.84740.01
3122973-12297341.27441.44
4123104-12310441.31841.48
5120711-12071140.51440.68
6125292-12529242.05242.22
30min1135159-13515945.36445.511.5545.5945.741.56
2132943-13294344.62044.85
3136637-13663745.86046.10
4136116-13611645.68545.91
5133856-13385644.92645.16
6138827-13882746.59546.84
45min1145915-14591548.97449.641.6049.2849.951.60
2144532-14453248.51048.81
3149105-14910550.04450.36
4149391-14939150.14050.45
5147576-14757649.53149.84
6150848-15084850.62950.95
60min1161261-16126154.12453.781.7354.5154.171.73
2155370-15537052.14752.53
3161855-16185554.32454.72
4160538-16053853.88254.27
5159096-15909653.39853.79
6163294-16329454.80755.21
极限1180984-18098460.74467.705.5361.2268.185.50
2202807-20280768.06968.54
3204107-20410768.50568.99
4200147-20014767.17667.65
5212583-21258371.35071.83
6209694-20969470.38070.88
辅酶Q10片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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%
110.882914042912592910722913872915052913250.06
210.792878032886192882110.21
单位质量响应值RSD%判断
26776.1926710.940.18数据可信
供试品溶液-24110401批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1121572-12157240.70840.111.6140.7140.111.60
2118675-11867539.73839.74
3118106-11810639.54739.55
4118660-11866039.73339.73
5122814-12281441.12441.12
6118952-11895239.83139.83
10min1142557-14255747.73546.483.8147.8046.543.80
2140043-14004346.89346.96
3133784-13378444.79744.86
4141187-14118747.27647.34
5144353-14435348.33648.40
6130928-13092843.84143.91
15min1145545-14554548.73549.884.7348.8850.024.72
2157344-15734452.68652.83
3146683-14668349.11649.26
4154405-15440551.70251.85
5151861-15186150.85051.00
6137884-13788446.17046.31
20min1156943-15694352.55252.145.1952.7852.365.17
2160495-16049553.74153.97
3155673-15567352.12752.35
4160758-16075853.82954.06
5160540-16054053.75653.99
6139826-13982646.82047.04
30min1157804-15780452.84051.327.1953.1651.647.17
2154094-15409451.59851.92
3147463-14746349.37849.69
4167988-16798856.25056.57
5156912-15691252.54252.87
6135339-13533945.31845.61
45min1163651-16365154.79855.009.1155.2055.409.05
2154370-15437051.69052.10
3189498-18949863.45363.84
4171706-17170657.49557.91
5159586-15958653.43753.85
6146750-14675049.13949.51
60min1161193-16119353.97555.285.0454.4755.775.02
2176619-17661959.14059.63
3163822-16382254.85555.35
4172801-17280157.86258.37
5162427-16242754.38854.89
6153702-15370251.46751.92
极限1215306-21530672.09567.904.7672.6868.484.72
2213826-21382671.59972.19
3196030-19603065.64066.23
4202480-20248067.80068.41
5193371-19337164.75065.34
6195641-19564165.51066.05
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