沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号DSMF-4022-230920对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.015694595693115693825695355689635693300.04
228.025753575749855751710.05
单位质量响应值RSD%判断
20325.9620527.160.70数据可信
影响因素30天-包装高温-供试品溶液-TAWW4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%
5min1182920-18292014.77213.3911.0814.7713.3911.09
2181246-18124614.63714.64
3179088-17908814.46214.46
4161996-16199613.08213.08
5151127-15112712.20412.20
6138478-13847811.18311.18
10min1380569-38056930.73330.035.6230.7730.065.62
2368352-36835229.74629.78
3396708-39670832.03632.07
4389719-38971931.47231.50
5345235-34523527.88027.91
6350759-35075928.32628.35
15min1508869-50886941.09441.816.8041.2041.906.80
2504756-50475640.76240.86
3552713-55271344.63544.74
4558835-55883545.12945.23
5518373-51837341.86141.95
6462700-46270037.36637.45
20min1615596-61559649.71349.754.9049.9149.944.90
2625943-62594350.54850.74
3637577-63757751.48851.69
4642907-64290751.91852.12
5615198-61519849.68149.86
6558927-55892745.13645.31
30min1636339-63633951.38852.212.0851.6952.512.08
2670844-67084454.17454.48
3646447-64644752.20452.52
4648782-64878252.39352.71
5644219-64421952.02452.32
6632591-63259151.08551.36
45min1639284-63928451.62652.281.8552.0452.701.85
2670814-67081454.17254.59
3644904-64490452.07952.51
4647282-64728252.27152.70
5643901-64390151.99852.41
6638267-63826751.54351.93
60min1634983-63498351.27852.191.9151.8152.721.90
2669787-66978754.08954.63
3644688-64468852.06252.61
4646898-64689852.24052.79
5642810-64281051.91052.43
6638557-63855751.56752.07
极限1633238-63323851.13752.131.9251.7852.781.92
2669258-66925854.04654.71
3642118-64211851.85452.52
4645963-64596352.16552.83
5642127-64212751.85552.49
6640225-64022551.70252.32
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号DSMF-4022-230920对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.015716725706145704915701295702515706310.11
228.025825705813345819520.16
单位质量响应值RSD%判断
20372.4020769.161.37数据可信
影响因素30天-包装高温-供试品溶液-TAWW4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%
5min1199925-19992516.03314.1615.8616.0314.1615.85
2138913-13891311.14011.14
3148907-14890711.94211.94
4194886-19488615.62915.63
5171335-17133513.74013.74
6205273-20527316.46216.46
10min1406871-40687132.62930.395.6332.6630.425.64
2367602-36760229.48029.50
3363845-36384529.17829.20
4405227-40522732.49732.53
5359536-35953628.83328.86
6370617-37061729.72229.76
15min1552173-55217344.28143.043.6744.3943.143.67
2535515-53551542.94543.04
3523391-52339141.97342.06
4567038-56703845.47345.58
5513942-51394241.21541.31
6528137-52813742.35442.46
20min1626208-62620850.21949.563.2850.4349.763.28
2633965-63396550.84151.03
3610889-61088948.99049.17
4640827-64082751.39151.60
5584564-58456446.87947.07
6611521-61152149.04149.24
30min1630863-63086350.59251.651.9450.9151.951.93
2653382-65338252.39852.70
3657343-65734352.71553.01
4644175-64417551.65951.98
5627121-62712150.29250.58
6651244-65124452.22652.53
45min1629943-62994350.51851.781.4950.9552.201.47
2650984-65098452.20552.62
3658094-65809452.77653.19
4643193-64319351.58152.02
5642469-64246951.52351.92
6649640-64964052.09852.52
60min1627583-62758350.32951.721.5350.8752.261.50
2649888-64988852.11852.65
3656699-65669952.66453.19
4642962-64296251.56252.11
5644104-64410451.65452.17
6648472-64847252.00452.54
极限1624975-62497550.12051.611.6250.7752.261.60
2648448-64844852.00252.65
3654669-65466952.50153.15
4640322-64032251.35052.02
5643268-64326851.58752.22
6649718-64971852.10452.76
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号DSMF-4022-230920对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.015705495690125698715700055691585697190.12
228.025773365769195771280.06
单位质量响应值RSD%判断
20339.8420597.000.89数据可信
影响因素30天-包装高湿-供试品溶液-TAWW4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%
5min1134441-13444110.83513.3214.1510.8313.3214.17
2166729-16672913.43713.44
3160977-16097712.97312.97
4205063-20506316.52616.53
5171481-17148113.82013.82
6153334-15333412.35712.36
10min1393327-39332731.69929.967.3531.7229.997.34
2339618-33961827.37027.40
3370197-37019729.83529.86
4401071-40107132.32332.36
5387835-38783531.25631.29
6338479-33847927.27927.31
15min1563694-56369445.42942.785.5545.5242.885.54
2506119-50611940.78940.88
3538197-53819743.37443.47
4557645-55764544.94145.05
5532041-53204142.87842.98
6487635-48763539.29939.39
20min1645441-64544152.01749.985.7452.2150.185.73
2640009-64000951.57951.76
3612824-61282449.38849.58
4638813-63881351.48351.69
5632850-63285051.00251.20
6551357-55135744.43544.61
30min1646672-64667252.11651.714.2752.4352.014.27
2676013-67601354.48154.78
3645794-64579452.04552.35
4643884-64388451.89252.21
5645510-64551052.02352.33
6591568-59156847.67547.95
45min1645879-64587952.05252.282.3752.4852.702.36
2676973-67697354.55854.98
3649592-64959252.35252.77
4643715-64371551.87852.32
5645581-64558152.02852.45
6630556-63055650.81751.20
60min1644826-64482651.96752.351.9152.5152.881.90
2674406-67440654.35154.89
3648676-64867652.27852.81
4642342-64234251.76752.32
5643218-64321851.83852.38
6643849-64384951.88952.38
极限1642475-64247551.77852.431.8652.4453.081.83
2673069-67306954.24454.90
3646356-64635652.09152.74
4641415-64141551.69352.36
5644877-64487751.97252.63
6655335-65533552.81453.42
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号DSMF-4022-230920对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.015848165854565849365838535852435848610.11
228.025933455920205926820.16
单位质量响应值RSD%判断
20880.4421152.110.92数据可信
影响因素30天-包装高湿-供试品溶液-TAWW4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%
5min1187363-18736314.70614.757.3514.7114.757.34
2162291-16229112.73812.74
3189983-18998314.91214.91
4196771-19677115.44515.44
5202455-20245515.89115.89
6188421-18842114.78914.79
10min1392336-39233630.79529.797.1230.8329.827.13
2331814-33181426.04426.07
3395527-39552731.04531.08
4392608-39260830.81630.85
5402002-40200231.55331.59
6362983-36298328.49128.52
15min1546982-54698242.93341.874.0943.0341.974.09
2495338-49533838.87938.97
3539378-53937842.33642.44
4556798-55679843.70343.81
5539496-53949642.34542.45
6522678-52267841.02541.12
20min1603661-60366147.38248.222.7347.5848.412.73
2591664-59166446.44046.61
3638987-63898750.15550.35
4624712-62471249.03449.23
5608408-60840847.75447.95
6618874-61887448.57648.76
30min1652684-65268451.23050.921.8751.5351.221.87
2648884-64888450.93151.21
3652445-65244551.21151.52
4649239-64923950.95951.27
5663072-66307252.04552.35
6626364-62636449.16449.46
45min1653972-65397251.33150.981.8051.7551.401.80
2651110-65111051.10651.50
3653212-65321251.27151.69
4649949-64994951.01551.44
5661757-66175751.94252.36
6627263-62726349.23449.64
60min1652058-65205851.18150.871.8351.7151.391.83
2649296-64929650.96451.47
3649952-64995251.01551.55
4647276-64727650.80551.34
5663000-66300052.03952.58
6626689-62668949.18949.70
极限1650781-65078151.08050.711.8051.7251.351.80
2647196-64719650.79951.41
3648356-64835650.89051.54
4643902-64390250.54051.19
5660772-66077251.86452.52
6625480-62548049.09449.72
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号DSMF-4022-230920对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.015687765707965730495711385712235709960.27
228.025823075820625821840.03
单位质量响应值RSD%判断
20385.4320777.441.35数据可信
影响因素30天-包装光照-供试品溶液-TAWW4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%
5min1197781-19778115.85313.8716.1115.8513.8616.12
2197482-19748215.82915.83
3199834-19983416.01716.02
4146032-14603211.70511.70
5146375-14637511.73211.73
6150424-15042412.05712.06
10min1388424-38842431.13329.907.9031.1729.927.91
2402830-40283032.28832.32
3399974-39997432.05932.09
4371033-37103329.73929.77
5337931-33793127.08627.11
6337678-33767827.06627.09
15min1550879-55087944.15542.905.0044.2642.995.01
2562018-56201845.04745.15
3551857-55185744.23344.34
4536559-53655943.00743.10
5520612-52061241.72941.81
6489175-48917539.20939.30
20min1619050-61905049.61949.433.7449.8249.623.73
2599385-59938548.04248.25
3648124-64812451.94952.15
4639574-63957451.26451.45
5603040-60304048.33548.51
6591294-59129447.39447.57
30min1642268-64226851.48051.761.4951.7952.061.47
2629838-62983850.48350.80
3653086-65308652.34752.67
4657272-65727252.68252.98
5647937-64793751.93452.22
6644203-64420351.63551.91
45min1645005-64500551.69951.961.2252.1352.381.21
2635405-63540550.93051.36
3651384-65138452.21052.65
4657201-65720152.67753.10
5654661-65466152.47352.87
6645932-64593251.77352.17
60min1643913-64391351.61251.931.2852.1552.461.27
2633462-63346250.77451.31
3651488-65148852.21952.77
4656185-65618552.59553.13
5653914-65391452.41352.93
6648015-64801551.94052.45
极限1643602-64360251.58751.831.2252.2452.481.20
2632474-63247450.69551.35
3649843-64984352.08752.76
4654262-65426252.44153.09
5651929-65192952.25452.89
6647651-64765151.91152.54
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号DSMF-4022-230920对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.015930025917685917425915505907795917680.14
228.026022145998506010320.28
单位质量响应值RSD%判断
21127.0321450.111.08数据可信
影响因素30天-包装光照-供试品溶液-TAWW4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%
5min1179537-17953713.91213.0114.0813.9113.0014.07
2191559-19155914.84414.84
3131364-13136410.17910.18
4152710-15271011.83311.83
5190129-19012914.73314.73
6161858-16185812.54212.54
10min1380800-38080029.50728.067.9529.5428.087.95
2383242-38324229.69729.73
3309248-30924823.96323.99
4356205-35620527.60227.63
5384433-38443329.78929.82
6358433-35843327.77427.80
15min1537685-53768541.66439.653.9741.7639.743.98
2510114-51011439.52839.63
3478871-47887137.10737.18
4511763-51176339.65639.74
5527583-52758340.88140.98
6504452-50445239.08939.18
20min1613690-61369047.55446.354.0747.7446.534.05
2580541-58054144.98545.17
3614144-61414447.58947.75
4618566-61856647.93148.11
5604731-60473146.85947.05
6557008-55700843.16143.34
30min1649819-64981950.35349.573.7350.6549.853.71
2651276-65127650.46650.75
3657753-65775350.96851.23
4655582-65558250.80051.08
5627571-62757148.62948.92
6596445-59644546.21746.49
45min1649072-64907250.29550.032.0950.7050.422.07
2653848-65384850.66551.06
3658259-65825951.00751.38
4655297-65529750.77851.17
5628966-62896648.73749.14
6628358-62835848.69049.07
60min1648258-64825850.23250.131.7950.7550.631.77
2653856-65385650.66651.18
3658687-65868751.04051.53
4654377-65437750.70651.21
5628394-62839448.69349.20
6638058-63805849.44249.93
极限1646535-64653550.09950.211.6350.7350.821.61
2652454-65245450.55751.18
3657454-65745450.94551.55
4651283-65128350.46751.09
5627635-62763548.63449.25
6652302-65230250.54651.14
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