枸橼酸西地那非片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号420012-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.8对照品水分(%)0对照品稀释倍数200
标示量(mg)50供试品稀释倍数1系数0.7118
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.454763484757084770504772604772544767240.15
214.454753204756434754820.05
单位质量响应值RSD%判断
32991.2832905.330.19数据可信
供试品溶液-2024041221批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min1390365-39036574.98966.3712.2674.9966.3712.26
2360436-36043669.23969.24
3367570-36757070.61070.61
4275053-27505352.83752.84
5364303-36430369.98269.98
6315158-31515860.54260.54
5min1515960-51596099.11594.265.7899.1294.265.78
2501807-50180796.39796.40
3506585-50658597.31497.31
4442784-44278485.05885.06
5507108-50710897.41597.41
6469939-46993990.27590.27
10min1520733-520733100.03299.501.43100.0399.501.43
2525005-525005100.853100.85
3520022-52002299.89699.90
4506993-50699397.39397.39
5524269-524269100.712100.71
6510905-51090598.14498.14
15min1524883-524883100.829100.640.45100.83100.640.45
2525713-525713100.989100.99
3524879-524879100.829100.83
4522478-522478100.368100.37
5525630-525630100.973100.97
6519825-51982599.85899.86
20min1526971-526971101.231100.890.51101.23100.890.51
2529043-529043101.629101.63
3523865-523865100.634100.63
4522943-522943100.457100.46
5526142-526142101.071101.07
6522140-522140100.303100.30
30min1527152-527152101.265100.810.58101.27100.810.58
2528472-528472101.519101.52
3523836-523836100.628100.63
4525956-525956101.036101.04
5523029-523029100.473100.47
6520142-52014299.91999.92
45min1527926-527926101.414101.070.55101.41101.070.55
2528123-528123101.452101.45
3525190-525190100.888100.89
4529582-529582101.732101.73
5523834-523834100.628100.63
6522129-522129100.300100.30
极限1525407-525407100.930101.090.43100.93101.090.43
2529850-529850101.784101.78
3525001-525001100.852100.85
4526745-526745101.187101.19
5527196-527196101.274101.27
6523365-523365100.538100.54
枸橼酸西地那非片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号420012-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.8对照品水分(%)0对照品稀释倍数200
标示量(mg)50供试品稀释倍数1系数0.7118
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.454759134775934773544758134772724767890.18
214.454748914750444749680.03
单位质量响应值RSD%判断
32995.7832869.760.28数据可信
供试品溶液-2024041221批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min1219724-21972442.22946.8614.9742.2346.8614.97
2266122-26612251.14651.15
3229190-22919044.04844.05
4245414-24541447.16647.17
5302518-30251858.14158.14
6200051-20005138.44838.45
5min1478775-47877592.01688.725.7192.0288.725.71
2486289-48628993.46093.46
3472560-47256090.82190.82
4444023-44402385.33785.34
5416448-41644880.03780.04
6471549-47154990.62790.63
10min1512888-51288898.57297.871.3998.5797.871.39
2517074-51707499.37699.38
3507081-50708197.45697.46
4511122-51112298.23398.23
5496478-49647895.41895.42
6510648-51064898.14198.14
15min1517753-51775399.50799.520.3899.5199.520.38
2521171-521171100.164100.16
3517485-51748599.45599.46
4516866-51686699.33699.34
5518346-51834699.62199.62
6515243-51524399.02599.02
20min1518260-51826099.60499.930.7099.6099.920.70
2523459-523459100.604100.60
3517925-51792599.54099.54
4517786-51778699.51399.51
5525473-525473100.991100.99
6516693-51669399.30399.30
30min1521159-521159100.162100.000.61100.16100.000.61
2521594-521594100.245100.25
3519094-51909499.76599.76
4520747-520747100.082100.08
5524331-524331100.771100.77
6514894-51489498.95798.96
45min1519312-51931299.807100.250.6699.81100.250.66
2523755-523755100.660100.66
3519692-51969299.88099.88
4521423-521423100.212100.21
5527332-527332101.348101.35
6518140-51814099.58199.58
极限1520983-520983100.128100.230.89100.13100.220.89
2522525-522525100.424100.42
3513386-51338698.66898.67
4523562-523562100.623100.62
5527420-527420101.365101.36
6521075-521075100.145100.15
枸橼酸西地那非片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号420012-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.8对照品水分(%)0对照品稀释倍数200
标示量(mg)50供试品稀释倍数1系数0.7118
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.454761434748594767054750764749104755390.18
214.454795654773264784460.34
单位质量响应值RSD%判断
32909.2733110.450.44数据可信
供试品溶液-2024041221批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min165650-6565012.58830.1632.2012.5930.1632.20
2149552-14955228.67528.68
3211743-21174340.60040.60
4191981-19198136.81136.81
5171000-17100032.78832.79
6153953-15395329.51929.52
5min1260286-26028649.90851.475.4349.9151.475.42
2258820-25882049.62749.63
3293171-29317156.21356.21
4277318-27731853.17453.17
5267089-26708951.21251.21
6254027-25402748.70848.71
10min1275104-27510452.74954.444.3252.7554.444.32
2268873-26887351.55451.55
3302961-30296158.09058.09
4291534-29153455.89955.90
5285754-28575454.79154.79
6279301-27930153.55453.55
15min1281859-28185954.04454.352.8754.0454.352.88
2273768-27376852.49352.49
3298575-29857557.24957.25
4281569-28156953.98953.99
5282772-28277254.21954.22
6282169-28216954.10454.10
20min1285995-28599554.83753.913.4154.8453.913.41
2272131-27213152.17952.18
3297482-29748257.04057.04
4280891-28089153.85953.86
5278158-27815853.33553.33
6272295-27229552.21052.21
30min1276912-27691253.09653.342.4453.1053.342.44
2268863-26886351.55251.55
3289482-28948255.50655.51
4279616-27961653.61453.61
5279398-27939853.57253.57
6274996-27499652.72852.73
45min1272639-27263952.27652.762.3852.2852.762.39
2266468-26646851.09351.09
3283229-28322954.30754.31
4282551-28255154.17754.18
5274239-27423952.58352.58
6271735-27173552.10352.10
极限1270714-27071451.90752.222.4951.9152.222.49
2264788-26478850.77150.77
3284843-28484354.61654.62
4270087-27008751.78751.79
5273670-27367052.47452.47
6269964-26996451.76351.76
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