枸橼酸西地那非片项目信息
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125
标示量(mg)100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%
117.459568539563149560099566339565899564800.04
217.599572149562669567400.08
单位质量响应值RSD%判断
54812.6154391.130.55数据可信
供试品溶液-2024051911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%
5min1564009-56400952.30450.5010.8652.3050.5010.86
2607473-60747356.33456.33
3560811-56081152.00752.01
4462853-46285342.92342.92
5591008-59100854.80754.81
6481061-48106144.61144.61
10min1585302-58530254.27852.048.4254.3752.128.43
2608857-60885756.46356.56
3567687-56768752.64552.73
4515130-51513047.77147.84
5597835-59783555.44155.53
6491983-49198345.62445.70
15min1579854-57985453.77351.878.0153.9552.048.01
2602448-60244855.86856.06
3570711-57071152.92553.10
4522154-52215448.42248.57
5592828-59282854.97655.16
6487927-48792745.24845.40
20min1574922-57492253.31651.567.6253.5851.827.62
2598944-59894455.54355.82
3565275-56527552.42152.68
4522409-52240948.44648.68
5586294-58629454.37054.65
6487943-48794345.25045.48
30min1564422-56442252.34250.556.9052.7050.896.91
2570091-57009152.86853.24
3556306-55630651.58951.94
4517593-51759347.99948.31
5579858-57985853.77354.14
6482040-48204044.70245.00
45min1555485-55548551.51350.167.3451.9650.597.35
2582461-58246154.01554.48
3551703-55170351.16251.60
4511744-51174447.45747.85
5568258-56825852.69853.15
6475951-47595144.13844.51
极限1520954-52095448.31146.926.1648.8447.436.18
2537903-53790349.88350.43
3514614-51461447.72348.24
4478614-47861444.38544.86
5526439-52643948.82049.36
6457382-45738242.41642.86
枸橼酸西地那非片项目信息
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125
标示量(mg)100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%
117.459558359559859551799553479545009553690.07
217.599535359533109534220.02
单位质量响应值RSD%判断
54748.9454202.500.71数据可信
供试品溶液-2024051911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%
5min1552079-55207951.31652.635.8851.3252.635.88
2609330-60933056.63856.64
3592772-59277255.09955.10
4514670-51467047.83947.84
5571210-57121053.09553.09
6557237-55723751.79651.80
10min1578656-57865653.78753.503.7753.8753.583.77
2603333-60333356.08156.17
3583590-58359054.24554.34
4537164-53716449.93050.01
5578619-57861953.78353.87
6571789-57178953.14953.23
15min1573554-57355453.31353.293.5153.4953.463.51
2599389-59938955.71455.90
3584479-58447954.32854.51
4538577-53857750.06150.22
5571282-57128253.10153.28
6572539-57253953.21853.39
20min1567452-56745252.74552.793.1053.0153.053.11
2595135-59513555.31955.60
3573760-57376053.33253.60
4540533-54053350.24350.49
5567478-56747852.74853.01
6563051-56305152.33652.60
30min1557074-55707451.78152.223.4752.1352.573.48
2585389-58538954.41354.79
3580901-58090153.99554.36
4531620-53162049.41549.74
5560284-56028452.07952.43
6555466-55546651.63151.98
45min1545064-54506450.66451.182.7851.1051.622.78
2572133-57213353.18053.64
3559818-55981852.03652.49
4526468-52646848.93649.35
5550889-55088951.20651.65
6548978-54897851.02851.47
极限1510182-51018247.42247.782.6047.9448.302.62
2532158-53215849.46550.02
3521371-52137148.46249.00
4491817-49181745.71546.21
5514103-51410347.78748.31
6514277-51427747.80348.32
枸橼酸西地那非片项目信息
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125
标示量(mg)100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%
117.459550289549789547749542669543229546740.04
217.599530589533389531980.03
单位质量响应值RSD%判断
54709.1154189.770.68数据可信
供试品溶液-2024052011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%
5min1441166-44116641.02748.2011.1541.0348.2011.15
2579331-57933153.87553.88
3561006-56100652.17152.17
4456557-45655742.45842.46
5555166-55516651.62851.63
6516324-51632448.01648.02
10min1466510-46651043.38449.897.3043.4549.977.31
2560750-56075052.14752.24
3576984-57698453.65753.74
4519383-51938348.30048.37
5546261-54626150.80050.89
6548702-54870251.02751.11
15min1468562-46856243.57450.507.7843.7250.667.78
2560422-56042252.11752.29
3589290-58929054.80254.98
4522653-52265348.60548.76
5554692-55469251.58451.75
6562401-56240152.30152.47
20min1467804-46780443.50449.286.5543.7249.526.56
2554264-55426451.54451.81
3562524-56252452.31252.58
4518419-51841948.21148.44
5548995-54899551.05451.31
6527243-52724349.03149.28
30min1469965-46996543.70549.426.7843.9949.756.78
2543403-54340350.53450.88
3575131-57513153.48553.84
4512959-51295947.70348.02
5541315-54131550.34050.68
6545830-54583050.76051.09
45min1467228-46722843.45048.606.2343.8149.016.24
2533357-53335749.60050.03
3561804-56180452.24552.69
4505332-50533246.99447.39
5530599-53059949.34449.77
6537226-53722649.96050.38
极限1457378-45737842.53445.704.6642.9746.194.69
2500559-50055946.55047.07
3521721-52172148.51849.05
4472614-47261443.95144.42
5495132-49513246.04546.55
6500937-50093746.58547.09
枸橼酸西地那非片项目信息
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125
标示量(mg)100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%
117.459541019537419542909539789538249539870.03
217.599535109544779539940.08
单位质量响应值RSD%判断
54669.7454235.020.57数据可信
供试品溶液-2024052011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%
5min1509869-50986947.41344.3715.1347.4144.3715.12
2546010-54601050.77450.77
3466351-46635143.36643.37
4489003-48900345.47345.47
5340128-34012831.62931.63
6511553-51155347.56947.57
10min1527849-52784949.08546.5511.9249.1646.6311.92
2539877-53987750.20350.29
3510149-51014947.43947.51
4498104-49810446.31946.39
5384168-38416835.72435.78
6543692-54369250.55850.64
15min1527281-52728149.03246.9810.4249.1947.1310.44
2546371-54637150.80750.98
3515490-51549047.93648.09
4499965-49996546.49246.64
5403244-40324437.49837.61
6539040-53904050.12550.29
20min1521448-52144848.49046.829.4048.7347.059.41
2539903-53990350.20650.46
3514713-51471347.86348.09
4498699-49869946.37446.60
5411752-41175238.28938.46
6534527-53452749.70649.95
30min1514625-51462547.85546.518.5048.1846.828.52
2533078-53307849.57149.91
3513870-51387047.78548.10
4490631-49063145.62445.93
5419094-41909438.97239.21
6529771-52977149.26449.59
45min1510072-51007247.43246.127.6247.8346.507.65
2521226-52122648.46948.89
3516883-51688348.06548.46
4489116-48911645.48345.87
5422385-42238539.27839.58
6515800-51580047.96448.38
极限1474379-47437944.11343.814.7444.5944.274.79
2488471-48847145.42345.92
3475244-47524444.19344.66
4467405-46740543.46443.92
5429626-42962639.95140.32
6491671-49167145.72146.21
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