枸橼酸西地那非口崩片项目信息
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%
113.824702054704034698994706194699084702070.07
213.884709274713124711200.06
单位质量响应值RSD%判断
34023.6633942.360.17数据可信
供试品溶液-2024041121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%
2min1228799-22879942.61439.8615.7942.6139.8615.79
2261379-26137948.68248.68
3163138-16313830.38430.38
4197656-19765636.81336.81
5230219-23021942.87842.88
6202857-20285737.78237.78
5min1323912-32391260.32961.555.9160.3361.555.91
2360118-36011867.07267.07
3306737-30673757.13057.13
4319294-31929459.46859.47
5325754-32575460.67260.67
6347045-34704564.63764.64
10min1324918-32491860.51660.672.6360.5260.672.63
2341419-34141963.58963.59
3327036-32703660.91060.91
4323333-32333360.22160.22
5321515-32151559.88259.88
6316117-31611758.87758.88
15min1332494-33249461.92761.222.6361.9361.222.63
2331779-33177961.79461.79
3334353-33435362.27362.27
4324965-32496560.52560.52
5312883-31288358.27458.27
6335860-33586062.55462.55
20min1318579-31857959.33559.392.1659.3459.392.16
2319448-31944859.49759.50
3330383-33038361.53461.53
4312437-31243758.19158.19
5311327-31132757.98557.98
6321051-32105159.79659.80
30min1304155-30415556.64956.963.2756.6556.963.26
2320285-32028559.65359.65
3314907-31490758.65158.65
4300461-30046155.96155.96
5302115-30211556.26956.27
6293138-29313854.59754.60
45min1283724-28372452.84454.242.4052.8454.242.40
2294202-29420254.79554.80
3300400-30040055.94955.95
4292920-29292054.55654.56
5282106-28210652.54252.54
6294063-29406354.76954.77
极限1280118-28011852.17253.072.0052.1753.072.00
2292646-29264654.50554.51
3288078-28807853.65553.65
4283574-28357452.81652.82
5277338-27733851.65451.65
6287949-28794953.63053.63
枸橼酸西地那非口崩片项目信息
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%
113.824714504704184704054708534711164708480.10
213.884703784705784704780.04
单位质量响应值RSD%判断
34070.0433896.110.37数据可信
供试品溶液-2024041121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%
2min1234218-23421843.62338.8311.9843.6238.8211.99
2215242-21524240.08940.09
3192326-19232635.82135.82
4214519-21451939.95439.95
5166736-16673631.05531.05
6227696-22769642.40942.41
5min1314284-31428458.53655.015.6158.5455.015.61
2304893-30489356.78656.79
3291744-29174454.33754.34
4308619-30861957.48057.48
5278198-27819851.81551.81
6274450-27445051.11651.12
10min1302204-30220456.28654.645.9656.2954.645.96
2303443-30344356.51656.52
3279263-27926352.01352.01
4319284-31928459.46759.47
5279847-27984752.12252.12
6276238-27623851.44951.45
15min1271729-27172950.61053.063.8550.6153.063.85
2282620-28262052.63852.64
3300666-30066655.99956.00
4279031-27903151.97051.97
5279849-27984952.12252.12
6295557-29555755.04855.05
20min1268957-26895750.09354.016.4750.0954.016.47
2298612-29861255.61755.62
3308930-30893057.53857.54
4300880-30088056.03956.04
5298664-29866455.62655.63
6263784-26378449.13049.13
30min1246403-24640345.89351.196.1945.8951.196.20
2280149-28014952.17852.18
3295283-29528354.99755.00
4278554-27855451.88151.88
5283750-28375052.84952.85
6264913-26491349.34049.34
45min1258905-25890548.22151.693.6848.2251.693.69
2283774-28377452.85352.85
3288517-28851753.73653.74
4280863-28086352.31152.31
5277601-27760151.70351.70
6275618-27561851.33451.33
极限1269034-26903450.10850.572.9750.1150.572.97
2271541-27154150.57550.57
3285108-28510853.10253.10
4267972-26797249.91049.91
5260922-26092248.59748.60
6274442-27444251.11551.11
枸橼酸西地那非口崩片项目信息
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%
113.824720814725194721204718674712744719720.10
213.884727234721464724340.09
单位质量响应值RSD%判断
34151.3734037.030.24数据可信
供试品溶液-2024041121批-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min1336280-33628062.42866.9510.9662.4366.9510.97
2306527-30652756.90556.90
3335147-33514762.21862.22
4399827-39982774.22574.23
5391018-39101872.59072.59
6395012-39501273.33173.33
5min1538976-538976100.05797.823.96100.0697.823.96
2487601-48760190.52090.52
3519232-51923296.39296.39
4539117-539117100.083100.08
5540572-540572100.353100.35
6536167-53616799.53699.54
10min1548527-548527101.830101.050.66101.83101.050.66
2543127-543127100.828100.83
3539218-539218100.102100.10
4544179-544179101.023101.02
5548308-548308101.789101.79
6542511-542511100.713100.71
15min1549511-549511102.013101.380.80102.01101.380.80
2545661-545661101.298101.30
3538435-53843599.95799.96
4545812-545812101.326101.33
5551061-551061102.301102.30
6546189-546189101.396101.40
20min1549312-549312101.976101.460.63101.98101.460.63
2545763-545763101.317101.32
3541535-541535100.532100.53
4546380-546380101.432101.43
5551277-551277102.341102.34
6545000-545000101.175101.18
30min1563086-563086104.533101.931.42104.53101.931.42
2544844-544844101.146101.15
3541547-541547100.534100.53
4546672-546672101.486101.49
5552625-552625102.591102.59
6545493-545493101.267101.27
45min1551504-551504102.383101.500.76102.38101.500.75
2547299-547299101.602101.60
3541401-541401100.507100.51
4543626-543626100.920100.92
5551346-551346102.353102.35
6545437-545437101.256101.26
极限1550380-550380102.174101.350.85102.17101.350.85
2546436-546436101.442101.44
3542278-542278100.670100.67
4542671-542671100.743100.74
5552381-552381102.546102.55
6541510-541510100.527100.53
枸橼酸西地那非口崩片项目信息
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%
113.824705844710154709724707964706754708080.04
213.884703484697754700620.09
单位质量响应值RSD%判断
34067.1533866.140.42数据可信
供试品溶液-2024041121批-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min1374124-37412469.71570.498.8469.7170.498.84
2328798-32879861.26961.27
3371021-37102169.13669.14
4415437-41543777.41377.41
5363734-36373467.77967.78
6416639-41663977.63777.64
5min1528720-52872098.52296.313.8098.5296.313.80
2481894-48189489.79789.80
3517397-51739796.41296.41
4525844-52584497.98697.99
5509636-50963694.96694.97
6537590-537590100.175100.18
10min1540325-540325100.685100.480.87100.68100.490.87
2532344-53234499.19899.20
3541619-541619100.926100.93
4536570-53657099.98599.99
5538570-538570100.358100.36
6546084-546084101.758101.76
15min1542207-542207101.035101.030.59101.04101.030.59
2538949-538949100.428100.43
3542591-542591101.107101.11
4538910-538910100.421100.42
5542905-542905101.166101.17
6547529-547529102.027102.03
20min1541111-541111100.831101.020.61100.83101.020.61
2536569-53656999.98599.98
3544506-544506101.464101.46
4541669-541669100.935100.94
5542589-542589101.107101.11
6546148-546148101.770101.77
30min1542023-542023101.001101.050.69101.00101.050.69
2539122-539122100.461100.46
3543659-543659101.306101.31
4537518-537518100.162100.16
5543447-543447101.267101.27
6547977-547977102.111102.11
45min1548379-548379102.186101.590.68102.19101.590.68
2540981-540981100.807100.81
3544639-544639101.489101.49
4542352-542352101.062101.06
5543887-543887101.348101.35
6550729-550729102.623102.62
极限1545455-545455101.641101.170.62101.64101.180.62
2540947-540947100.801100.80
3544674-544674101.495101.50
4539416-539416100.515100.52
5539798-539798100.587100.59
6547357-547357101.995102.00
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