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)1.5
对照品批号10071-202203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%
110.158409883885839488404484018839990.10
210.258374783686837160.06
单位质量响应值RSD%判断
8275.768167.410.94数据可信
供试品溶液-24090401批-比索洛尔-pH6.8hcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min190511-9051198.887100.381.8798.89100.381.87
291300-9130099.74999.75
391727-91727100.215100.22
489911-8991198.23198.23
594237-94237102.957102.96
693596-93596102.257102.26
10min191928-91928100.435102.031.64100.60102.201.64
293995-93995102.693102.86
392788-92788101.374101.54
491588-91588100.063100.23
594662-94662103.422103.59
695366-95366104.191104.36
15min191421-9142199.881101.871.56100.21102.211.57
294265-94265102.988103.33
392465-92465101.021101.36
492000-92000100.513100.84
594463-94463103.204103.55
694846-94846103.623103.97
20min191622-91622100.100102.091.65100.60102.601.65
294346-94346103.076103.59
392654-92654101.228101.73
492023-92023100.539101.04
594770-94770103.540104.06
695260-95260104.075104.59
30min191820-91820100.317102.041.59100.98102.721.59
294581-94581103.333104.01
392585-92585101.153101.83
491826-91826100.323100.99
594598-94598103.352104.04
694968-94968103.756104.45
45min191571-91571100.045101.861.58100.88102.711.57
294579-94579103.331104.18
392395-92395100.945101.79
491814-91814100.310101.14
594350-94350103.081103.94
694713-94713103.477104.34
极限191478-9147899.943101.791.58100.94102.811.58
294535-94535103.283104.31
392471-92471101.028102.04
491692-91692100.177101.18
594043-94043102.745103.78
694796-94796103.568104.60
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)1.5
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0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.931046301049511047311051861043471047690.31
213.991048101047161047630.07
单位质量响应值RSD%判断
7521.117488.420.31数据可信
供试品溶液-24090401批-氨氯地平-pH6.8hcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min164260-6426055.51553.343.7255.5153.343.72
258650-5865050.66850.67
362818-6281854.26954.27
461556-6155653.17953.18
563730-6373055.05755.06
659436-5943651.34751.35
10min183735-8373572.34068.943.5772.4369.033.57
276059-7605965.70865.79
380094-8009469.19469.28
479044-7904468.28768.38
582200-8220071.01371.11
677688-7768867.11567.20
15min188513-8851376.46772.483.9176.6872.683.91
280658-8065869.68169.88
384751-8475173.21773.42
483042-8304271.74171.94
586324-8632474.57674.79
680095-8009569.19569.39
20min189529-8952977.34575.302.6277.6975.632.63
283663-8366372.27772.59
387622-8762275.69876.03
485715-8571574.05074.37
589577-8957777.38677.72
686889-8688975.06475.38
30min194233-9423381.40977.583.3681.8878.043.36
286934-8693475.10375.53
389749-8974977.53577.99
487779-8777975.83376.28
592639-9263980.03280.50
687504-8750475.59676.03
45min196131-9613183.04980.222.3783.6580.802.38
290358-9035878.06178.62
392727-9272780.10880.69
492193-9219379.64680.22
594700-9470081.81282.41
691027-9102778.63979.20
极限1104639-10463990.39987.751.8791.1488.471.87
2101534-10153487.71688.40
3102122-10212288.22488.94
499301-9930185.78786.49
5101992-10199288.11288.85
699882-9988286.28986.98
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)1.5
对照品批号10071-202203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%
110.158404084012840698372384118839920.19
210.258405984200841300.12
单位质量响应值RSD%判断
8275.078207.800.58数据可信
供试品溶液-24090402批-比索洛尔-pH6.8hcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min190396-9039698.520100.433.0098.52100.433.00
290166-9016698.27098.27
389725-8972597.78997.79
492644-92644100.971100.97
597082-97082105.807105.81
692893-92893101.242101.24
10min193047-93047101.410102.622.19101.57102.782.19
293069-93069101.434101.60
392758-92758101.095101.26
493670-93670102.089102.26
598237-98237107.066107.24
694136-94136102.597102.77
15min193552-93552101.960103.181.88102.29103.521.88
294234-94234102.703103.04
393616-93616102.030102.36
493798-93798102.228102.57
598193-98193107.018107.37
694647-94647103.154103.49
20min193592-93592102.004103.341.85102.51103.851.86
293822-93822102.254102.76
394566-94566103.065103.57
493914-93914102.355102.86
598282-98282107.115107.65
694720-94720103.233103.74
30min193405-93405101.800103.182.06102.47103.872.06
294144-94144102.605103.28
393868-93868102.305102.98
493463-93463101.863102.54
598528-98528107.383108.10
694644-94644103.150103.83
45min193568-93568101.978103.192.13102.82104.042.13
294145-94145102.606103.45
393834-93834102.267103.11
493471-93471101.872102.72
598727-98727107.600108.49
694339-94339102.818103.67
极限193185-93185101.560102.882.01102.57103.912.01
293882-93882102.320103.34
393618-93618102.032103.05
493208-93208101.585102.60
598166-98166106.989108.06
694330-94330102.808103.84
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)1.5
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0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.931047331049721049391047201047991048330.12
213.991051111050791050950.03
单位质量响应值RSD%判断
7525.707512.150.13数据可信
供试品溶液-24090402批-氨氯地平-pH6.8hcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min163669-6366954.90053.993.3954.9053.983.39
259633-5963351.42051.42
360328-6032852.02052.02
464900-6490055.96255.96
563883-6388355.08555.08
663242-6324254.53254.53
10min183107-8310771.66169.622.5871.7569.712.58
278365-7836567.57367.66
378288-7828867.50667.59
482738-8273871.34371.44
581361-8136170.15670.25
680556-8055669.46269.55
15min188844-8884476.60874.502.3276.8274.712.32
283929-8392972.37072.57
384426-8442672.79973.00
488285-8828576.12676.34
586947-8694774.97375.18
685978-8597874.13774.34
20min190463-9046378.00476.302.3778.3476.642.37
285812-8581273.99474.31
386129-8612974.26774.59
490454-9045477.99778.34
589677-8967777.32777.66
688418-8841876.24176.57
30min194471-9447181.46078.692.8381.9379.152.83
288464-8846476.28176.72
388049-8804975.92376.37
492103-9210379.41979.89
593300-9330080.45180.91
691164-9116478.60979.07
45min197972-9797284.47980.883.0785.0881.473.07
290994-9099478.46279.03
390720-9072078.22678.80
495491-9549182.34082.94
595207-9520782.09582.69
692439-9243979.70880.30
极限1106144-10614491.52687.562.8292.2788.282.82
298058-9805884.55385.25
3101591-10159187.60088.30
4101276-10127687.32888.07
5102984-10298488.80189.53
699197-9919785.53686.26
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)1.5
对照品批号10071-202203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%
110.158383783888839858397383809838980.10
210.258335583406833800.05
单位质量响应值RSD%判断
8265.818134.631.14数据可信
供试品溶液-24090403批-比索洛尔-pH6.8hcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min197891-97891107.230103.343.10107.23103.343.10
293552-93552102.477102.48
390176-9017698.77998.78
492900-92900101.763101.76
594032-94032103.003103.00
697474-97474106.774106.77
10min198340-98340107.722104.152.76107.90104.322.76
294303-94303103.300103.47
391330-91330100.043100.21
493940-93940102.902103.07
594725-94725103.762103.93
697855-97855107.191107.37
15min198365-98365107.750104.322.51108.11104.672.51
294282-94282103.277103.62
391907-91907100.675101.01
494105-94105103.083103.42
595183-95183104.264104.61
697562-97562106.870107.23
20min198289-98289107.666104.262.41108.20104.782.41
294513-94513103.530104.05
392107-92107100.895101.39
493891-93891102.849103.36
594901-94901103.955104.47
697395-97395106.687107.22
30min198184-98184107.551104.312.45108.27105.002.45
294343-94343103.344104.03
392079-92079100.864101.53
493898-93898102.856103.54
595157-95157104.236104.93
697662-97662106.980107.69
45min198223-98223107.594104.192.35108.49105.062.35
294164-94164103.148104.01
392044-92044100.826101.66
494158-94158103.141104.00
594989-94989104.052104.92
697096-97096106.360107.25
极限197696-97696107.017103.912.42108.09104.952.42
294024-94024102.994104.03
391523-91523100.255101.26
493874-93874102.830103.86
594881-94881103.933104.97
697172-97172106.443107.51
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)1.5
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0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.931043111049711047191046501047471046800.23
213.991042941045061044000.15
单位质量响应值RSD%判断
7514.727462.470.50数据可信
供试品溶液-24090403批-氨氯地平-pH6.8hcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min168606-6860659.39859.663.0959.4059.663.09
269477-6947760.15260.15
364798-6479856.10156.10
469650-6965060.30260.30
570342-7034260.90160.90
670555-7055561.08561.09
10min180481-8048169.67971.584.0069.7871.684.00
284171-8417172.87472.97
376908-7690866.58666.68
485245-8524573.80473.90
584648-8464873.28773.39
684606-8460673.25073.35
15min186825-8682575.17276.872.2575.3977.092.26
292141-9214179.77480.00
386739-8673975.09775.30
489590-8959077.56577.79
588649-8864976.75176.97
688784-8878476.86877.09
20min191339-9133979.08079.751.3179.4280.091.31
294121-9412181.48881.84
390591-9059178.43278.76
492248-9224879.86780.22
591826-9182679.50179.85
692543-9254380.12280.47
30min192779-9277980.32681.892.2680.8082.372.26
297121-9712184.08684.58
391824-9182479.50079.96
495427-9542782.61983.10
593760-9376081.17681.66
696574-9657483.61284.10
45min197415-9741584.34082.742.7084.9583.352.68
298342-9834285.14385.77
395145-9514582.37582.97
495047-9504782.29082.91
596426-9642683.48484.10
690994-9099478.78179.41
极限1101028-10102887.46889.701.6988.2190.461.69
2105758-10575891.56392.34
3102310-10231088.57889.31
4104943-10494390.85891.62
5104259-10425990.26691.02
6103357-10335789.48590.24
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