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250
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%
117.274743014742944742564738334741894741750.05
217.234743184741914742540.02
单位质量响应值RSD%判断
27456.5727524.900.18数据可信
供试品溶液-2024041511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%
5min1533216-53321698.21297.442.9398.2197.442.93
2542921-542921100.000100.00
3546947-546947100.741100.74
4525494-52549496.79096.79
5504713-50471392.96292.96
6520944-52094495.95295.95
10min1539051-53905199.28798.911.9199.4599.081.91
2545543-545543100.483100.65
3542108-54210899.850100.02
4531441-53144197.88598.05
5519022-51902295.59895.75
6545014-545014100.385100.55
15min1537518-53751899.00499.311.7099.3399.641.70
2545760-545760100.523100.86
3546974-546974100.746101.08
4535498-53549898.63298.96
5523361-52336196.39796.71
6546005-546005100.568100.89
20min1537674-53767499.03399.161.5799.5399.651.57
2544383-544383100.269100.77
3545609-545609100.495101.00
4532071-53207198.00198.49
5525021-52502196.70397.18
6545405-545405100.457100.95
30min1536451-53645198.80899.261.4899.4799.921.48
2542666-54266699.953100.62
3549286-549286101.172101.84
4533536-53353698.27198.92
5527453-52745397.15197.79
6544069-544069100.211100.87
45min1535074-53507498.55499.081.2399.3899.901.24
2542365-54236599.897100.73
3543782-543782100.158101.00
4534965-53496598.53499.35
5527344-52734497.13197.93
6543891-543891100.178101.01
极限1533264-53326498.22199.190.7099.21100.180.70
2540833-54083399.615100.62
3541732-54173299.781100.79
4537594-53759499.018100.00
5535250-53525098.58799.55
6542349-54234999.894100.89
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250
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%
117.274745304747334745974747864747134746720.03
217.234738654740504739580.03
单位质量响应值RSD%判断
27485.3527507.720.06数据可信
供试品溶液-2024041511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%
5min1534874-53487498.49798.831.8198.5098.831.81
2531403-53140397.85797.86
3540344-54034499.50499.50
4554533-554533102.117102.12
5528449-52844997.31397.31
6530595-53059597.70997.71
10min1545126-545126100.384100.241.65100.55100.401.65
2536315-53631598.76298.93
3546240-546240100.590100.76
4560679-560679103.249103.42
5537175-53717598.92099.08
6540434-54043499.52099.68
15min1544726-544726100.311100.061.65100.64100.391.64
2535384-53538498.59098.92
3544915-544915100.346100.68
4559597-559597103.049103.39
5536375-53637598.77399.10
6539236-53923699.30099.63
20min1543939-543939100.16699.881.72100.66100.381.72
2533597-53359798.26198.75
3544585-544585100.285100.79
4559021-559021102.943103.46
5535301-53530198.57599.07
6537785-53778599.03399.53
30min1542470-54247099.89599.621.71100.56100.281.71
2532798-53279898.11498.77
3542613-54261399.922100.59
4557569-557569102.676103.36
5532869-53286998.12798.78
6537497-53749798.98099.64
45min1540736-54073699.57699.401.59100.41100.231.60
2532189-53218998.00298.82
3540848-54084899.597100.43
4555576-555576102.309103.17
5533103-53310398.17098.99
6536108-53610898.72499.55
极限1540530-54053099.53899.311.70100.54100.301.70
2532858-53285898.12599.11
3541828-54182899.777100.78
4555805-555805102.351103.38
5532121-53212197.99098.97
6532511-53251198.06199.05
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250
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%
117.274741774745524742164738474741234741830.06
217.234747394749514748450.04
单位质量响应值RSD%判断
27457.0427559.200.27数据可信
供试品溶液-2024051711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%
5min1510578-51057893.98398.072.5093.9898.062.50
2526440-52644096.90396.90
3545513-545513100.414100.41
4532485-53248598.01698.02
5546187-546187100.538100.54
6535331-53533198.54098.54
10min1553269-553269101.841100.481.67102.00100.651.67
2531749-53174997.88098.04
3552312-552312101.665101.83
4540810-54081099.54899.71
5554802-554802102.124102.29
6542441-54244199.848100.01
15min1553513-553513101.886100.441.68102.21100.771.68
2531185-53118597.77698.10
3551904-551904101.590101.93
4540258-54025899.44699.78
5554037-554037101.983102.32
6542919-54291999.936100.27
20min1551930-551930101.595100.431.97102.09100.931.97
2529928-52992897.54598.03
3551480-551480101.512102.02
4538831-53883199.18499.68
5559533-559533102.994103.50
6541922-54192299.753100.25
30min1551087-551087101.440100.081.68102.11100.741.68
2528992-52899297.37398.02
3550074-550074101.253101.93
4538836-53883699.18599.85
5552106-552106101.627102.31
6541040-54104099.590100.25
45min1549837-549837101.21099.811.59102.04100.641.59
2528238-52823897.23498.05
3547565-547565100.791101.64
4538140-53814099.05799.88
5550194-550194101.275102.12
6539386-53938699.286100.12
极限1549161-549161101.08599.671.66102.09100.671.66
2527149-52714997.03398.01
3547354-547354100.753101.76
4536448-53644898.74599.74
5549942-549942101.229102.25
6538863-53886399.190100.18
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250
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%
117.274746004747964739754749264747994746190.08
217.234739834741194740510.03
单位质量响应值RSD%判断
27482.2827513.120.08数据可信
供试品溶液-2024051711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%
5min1519064-51906495.58195.963.8995.5895.963.89
2530825-53082597.74797.75
3512965-51296594.45894.46
4485770-48577089.45089.45
5539671-53967199.37699.38
6538301-53830199.12399.12
10min1525918-52591896.84398.482.2197.0098.642.21
2537756-53775699.02399.19
3540431-54043199.51699.67
4515513-51551394.92795.08
5542565-54256599.909100.07
6546701-546701100.670100.84
15min1526458-52645896.94398.701.8197.2699.031.81
2537523-53752398.98099.31
3539717-53971799.38499.71
4522180-52218096.15596.46
5543956-543956100.165100.50
6546265-546265100.590100.92
20min1526681-52668196.98498.741.5297.4799.231.52
2537163-53716398.91499.41
3538697-53869799.19699.69
4526190-52619096.89397.36
5543262-543262100.037100.54
6545257-545257100.404100.90
30min1526170-52617096.89098.821.3097.5399.471.30
2535713-53571398.64799.30
3537914-53791499.05299.71
4532138-53213897.98998.62
5542836-54283699.959100.62
6544985-544985100.354101.02
45min1525387-52538796.74598.671.0697.5599.491.06
2535113-53511398.53699.36
3535963-53596398.69399.51
4537263-53726398.93299.72
5541031-54103199.626100.46
6540338-54033899.499100.33
极限1523600-52360096.41698.901.4797.3899.881.46
2534915-53491598.50099.49
3535137-53513798.54199.52
4546058-546058100.552101.51
5539868-53986899.412100.41
6542798-54279899.952100.95
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