比索洛尔氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号100711-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.828293882940829528295482978829520.02
29.858276282725827440.04
单位质量响应值RSD%判断
8447.258400.410.40数据可信
影响因素30天-供试品溶液-2024021621批-比索洛尔-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%
5min190840-9084096.86096.741.2096.8696.741.20
290718-9071896.73096.73
389042-8904294.94394.94
490379-9037996.36896.37
590982-9098297.01197.01
692398-9239898.52198.52
10min191794-9179497.87797.321.3098.0497.481.30
291224-9122497.26997.43
389760-8976095.70895.87
490179-9017996.15596.32
591633-9163397.70597.87
693044-9304499.21099.37
15min191633-9163397.70597.251.2598.0397.581.25
291166-9116697.20897.53
389651-8965195.59295.91
490416-9041696.40896.73
591397-9139797.45497.78
692999-9299999.16299.49
20min191205-9120597.24997.041.2797.7497.521.26
290894-9089496.91797.40
389535-8953595.46895.95
490000-9000095.96496.45
591705-9170597.78298.27
692701-9270198.84499.34
30min190865-9086596.88796.781.2797.5497.431.27
290962-9096296.99097.64
389095-8909594.99995.64
490052-9005296.02096.66
591086-9108697.12297.77
692535-9253598.66799.33
45min190971-9097197.00096.651.2197.8197.461.21
290421-9042196.41397.22
389153-8915395.06195.86
489998-8999895.96296.76
590874-9087496.89697.71
692419-9241998.54499.37
极限190644-9064496.65196.461.2897.6297.431.28
290391-9039196.38197.35
389061-8906194.96395.92
489487-8948795.41796.38
590852-9085296.87397.85
692350-9235098.47099.46
比索洛尔氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.801041091043331043461042691042101042530.10
213.761039511040021039760.04
单位质量响应值RSD%判断
7554.577556.400.02数据可信
影响因素30天-供试品溶液-2024021621批-氨氯地平-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%
5min1103494-10349488.79788.431.9288.8088.431.91
2104154-10415489.36389.36
3103834-10383489.08889.09
4101830-10183087.36987.37
5105305-10530590.35090.35
699765-9976585.59785.60
10min1112422-11242296.45796.541.6996.6096.681.69
2114718-11471898.42798.58
3114351-11435198.11298.26
4109913-10991394.30494.45
5112864-11286496.83696.99
6110811-11081195.07595.22
15min1112637-11263796.64197.011.3296.9597.321.32
2115186-11518698.82899.14
3113905-11390597.72998.04
4111716-11171695.85196.15
5113722-11372297.57297.88
6111227-11122795.43195.73
20min1112311-11231196.36196.841.8796.8397.321.87
2114915-11491598.59699.07
3115228-11522898.86499.34
4110248-11024894.59195.05
5113790-11379097.63098.11
6110755-11075595.02695.49
30min1112250-11225096.30996.911.4596.9497.541.45
2115196-11519698.83799.48
3114060-11406097.86298.50
4111104-11110495.32695.95
5113750-11375097.59698.23
6111369-11136995.55396.17
45min1112105-11210596.18596.641.0796.9897.431.08
2113285-11328597.19798.00
3113879-11387997.70798.51
4111610-11161095.76096.54
5113845-11384597.67898.48
6111064-11106495.29296.07
极限1111395-11139595.57696.761.6596.5397.711.65
2114556-11455698.28899.26
3114551-11455198.28399.25
4110569-11056994.86795.81
5114219-11421997.99998.96
6111343-11134395.53196.47
比索洛尔氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号100711-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.828273582754827788280282827827790.05
29.858284382843828430.00
单位质量响应值RSD%判断
8429.638410.460.17数据可信
影响因素30天-供试品溶液-2024021621批-比索洛尔-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%
5min192137-9213798.28697.612.0798.2997.602.08
292675-9267598.86098.86
391258-9125897.34997.35
488140-8814094.02394.02
593657-9365799.90899.91
691123-9112397.20597.20
10min192967-9296799.17298.952.0399.3499.112.04
293763-93763100.021100.19
393195-9319599.41599.58
489270-8927095.22895.38
594820-94820101.148101.31
692524-9252498.69998.86
15min192836-9283699.03298.791.9099.3699.121.90
293678-9367899.930100.26
393011-9301199.21999.55
489328-8932895.29095.61
594402-94402100.703101.04
692409-9240998.57798.90
20min192628-9262898.81098.852.4199.3099.352.40
293475-9347599.714100.21
392960-9296099.16499.66
489125-8912595.07395.55
595966-95966102.371102.87
691865-9186597.99698.49
30min192293-9229398.45398.411.8699.1199.071.86
293243-9324399.466100.13
392884-9288499.08399.74
489222-8922295.17795.81
594196-94196100.483101.16
691691-9169197.81198.46
45min192056-9205698.20098.171.9099.0298.991.90
293082-9308299.294100.12
392618-9261898.79999.62
488922-8892294.85795.65
593977-93977100.249101.09
691517-9151797.62598.44
极限192006-9200698.14798.021.9799.1399.001.97
292648-9264898.83199.83
392407-9240798.57499.56
488542-8854294.45195.40
593933-93933100.202101.21
691794-9179497.92098.90
比索洛尔氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.801039211039541040381039771040501039880.06
213.761041331041731041530.03
单位质量响应值RSD%判断
7535.367569.260.32数据可信
影响因素30天-供试品溶液-2024021621批-氨氯地平-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%
5min1107167-10716791.98790.312.0491.9990.312.04
2103869-10386989.15689.16
3107078-10707891.91191.91
4102022-10202287.57187.57
5104269-10426989.50089.50
6106892-10689291.75191.75
10min1112616-11261696.66495.232.6496.8295.382.64
2107547-10754792.31392.46
3115182-11518298.86799.02
4107919-10791992.63392.78
5110433-11043394.79094.94
6111998-11199896.13496.29
15min1112560-11256096.61695.502.2896.9395.812.28
2109655-10965594.12394.43
3114325-11432598.13198.45
4107973-10797392.67992.98
5109600-10960094.07594.38
6113457-11345797.38697.70
20min1112824-11282496.84395.422.7597.3295.892.74
2108963-10896393.52993.99
3115845-11584599.43699.92
4107852-10785292.57593.03
5109084-10908493.63394.10
6112440-11244096.51396.99
30min1111823-11182395.98495.752.4396.6296.372.43
2109401-10940193.90594.52
3116193-11619399.735100.38
4108588-10858893.20793.82
5110715-11071595.03295.65
6112555-11255596.61297.25
45min1111687-11168795.86795.652.4596.6696.442.45
2109642-10964294.11194.88
3115961-11596199.535100.35
4108207-10820792.88093.64
5110358-11035894.72695.50
6112773-11277396.79997.60
极限1111732-11173295.90595.302.9296.8696.252.92
2108357-10835793.00893.94
3115493-11549399.134100.11
4106827-10682791.69592.61
5110176-11017694.57095.51
6113598-11359897.50798.47
比索洛尔氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号100711-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.828242082367823888234282287823610.07
29.858239782399823980.01
单位质量响应值RSD%判断
8387.078365.280.19数据可信
影响因素30天-供试品溶液-2024021621批-比索洛尔-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%
5min193752-93752100.53397.682.33100.5397.682.33
290362-9036296.89896.90
389843-8984396.34196.34
493307-93307100.056100.06
588187-8818794.56594.57
691084-9108497.67297.67
10min194409-94409101.23898.712.33101.4198.872.33
291128-9112897.71997.88
391178-9117897.77397.93
494564-94564101.404101.57
588991-8899195.42895.59
692023-9202398.67998.84
15min194569-94569101.40998.822.39101.7599.152.39
291178-9117897.77398.10
391151-9115197.74498.07
494787-94787101.643101.98
589095-8909595.53995.86
692149-9214998.81499.14
20min194570-94570101.41098.562.57101.9299.052.58
290982-9098297.56398.05
390920-9092097.49697.98
494599-94599101.441101.95
588486-8848694.88695.36
691921-9192198.57099.06
30min194510-94510101.34698.662.71102.0299.322.71
291495-9149598.11398.76
391092-9109297.68198.33
495083-95083101.960102.63
588264-8826494.64895.28
691607-9160798.23398.89
45min193895-93895100.68698.102.50101.5398.922.50
290379-9037996.91697.73
390747-9074797.31198.12
494201-94201101.014101.86
588149-8814994.52595.32
691535-9153598.15698.98
极限194222-94222101.03798.042.24102.0599.032.25
290665-9066597.22398.20
390087-9008796.60397.58
493354-93354100.106101.12
588771-8877195.19296.14
691481-9148198.09899.08
比索洛尔氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.801035661034791032521033571032611033830.14
213.761035761031031033400.33
单位质量响应值RSD%判断
7491.527510.170.18数据可信
影响因素30天-供试品溶液-2024021621批-氨氯地平-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%
5min1107272-10727292.70991.022.9092.7191.022.90
2103320-10332089.29389.29
3105694-10569491.34591.34
4100328-10032886.70786.71
5106500-10650092.04192.04
6108803-10880394.03294.03
10min1113575-11357598.15696.382.0098.3196.532.00
2110129-11012995.17895.33
3111592-11159296.44296.59
4107922-10792293.27093.41
5112053-11205396.84196.99
6113826-11382698.37398.53
15min1114168-11416898.66896.572.6898.9996.892.68
2110315-11031595.33895.65
3112453-11245397.18697.50
4106662-10666292.18192.48
5111892-11189296.70197.02
6114977-11497799.36899.69
20min1113503-11350398.09496.591.9498.5897.061.95
2110205-11020595.24395.71
3112147-11214796.92297.40
4108381-10838193.66794.12
5112041-11204196.83097.31
6114274-11427498.76099.25
30min1112857-11285797.53596.272.3498.1896.902.34
2108977-10897794.18294.81
3112119-11211996.89897.53
4107776-10777693.14493.75
5111698-11169896.53497.17
6114897-11489799.29899.95
45min1113664-11366498.23396.232.3699.0497.022.36
2109284-10928494.44795.23
3111237-11123796.13596.93
4107574-10757492.97093.73
5111741-11174196.57197.37
6114559-11455999.00699.82
极限1113815-11381598.36395.292.4299.3496.242.42
2109159-10915994.33995.28
3110954-11095495.89196.85
4105967-10596791.58192.50
5109781-10978194.87795.84
6111849-11184996.66497.65
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