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%
110.298593585837858748580685992858890.09
210.298691886821868700.08
单位质量响应值RSD%判断
8346.848442.180.81数据可信
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%
5min187190-8719093.29590.592.2693.3090.582.26
286403-8640392.45392.45
382685-8268588.47588.47
485306-8530691.27991.28
583411-8341189.25189.25
682953-8295388.76188.76
10min194200-94200100.79698.232.07100.9598.382.07
293237-9323799.76599.92
388991-8899195.22295.37
492513-9251398.99199.14
590529-9052996.86897.02
691351-9135197.74797.90
15min195691-95691102.39199.552.35102.7199.862.35
295254-95254101.924102.24
390035-9003596.33996.65
493126-9312699.64799.96
591353-9135397.75098.06
692756-9275699.25199.56
20min196085-96085102.81399.752.23103.31100.232.24
295125-95125101.786102.28
390612-9061296.95797.42
493179-9317999.703100.19
591578-9157897.99098.46
692732-9273299.22599.70
30min196528-96528103.287100.112.27103.95100.762.27
295537-95537102.226102.89
390960-9096097.32997.96
493523-93523100.071100.72
591957-9195798.39699.03
692874-9287499.377100.02
45min196176-96176102.91099.792.33103.75100.612.33
295413-95413102.094102.92
390879-9087997.24298.03
493330-9333099.865100.68
591206-9120697.59298.39
692583-9258399.06699.87
极限195888-95888102.60299.462.40103.61100.442.40
295069-95069101.726102.73
390173-9017396.48797.44
492908-9290899.413100.40
590983-9098397.35498.32
692678-9267899.167100.14
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0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.631036211035421033291033811033881034520.12
213.711025721024051024880.12
单位质量响应值RSD%判断
7590.027475.421.08数据可信
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%
5min171747-7174761.74865.713.2961.7565.713.29
278010-7801067.13867.14
377611-7761166.79466.79
478305-7830567.39267.39
577236-7723666.47266.47
675199-7519964.71964.72
10min187124-8712474.98281.594.4375.0881.704.43
292976-9297680.01880.13
395886-9588682.52282.63
498230-9823084.54084.65
597657-9765784.04784.16
696957-9695783.44483.55
15min196913-9691383.40687.342.5283.6387.592.53
2100230-10023086.26186.51
3102091-10209187.86388.11
4103718-10371889.26389.52
5103376-10337688.96889.22
6102604-10260488.30488.55
20min1100813-10081386.76389.302.4987.1389.702.50
2100176-10017686.21486.60
3104893-10489390.27490.67
4105871-10587191.11691.52
5104875-10487590.25990.66
6105961-10596191.19391.59
30min1105743-10574391.00692.911.8391.5293.451.83
2107656-10765692.65293.18
3108788-10878893.62694.17
4108832-10883293.66494.22
5110888-11088895.43495.98
6105860-10586091.10691.65
45min1106188-10618891.38994.941.9192.0595.641.91
2111274-11127495.76696.45
3110170-11017094.81695.52
4111074-11107495.59496.30
5111900-11190096.30597.01
6111297-11129795.78696.48
极限1109595-10959594.32195.641.1695.1496.491.15
2111446-11144695.91496.76
3112590-11259096.89897.76
4109932-10993294.61195.48
5110659-11065995.23696.11
6112528-11252896.84597.70
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%
110.298590385958859678578085955859130.10
210.298543185536854840.09
单位质量响应值RSD%判断
8349.178307.480.36数据可信
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%
5min178794-7879484.97988.659.1784.9888.659.17
272017-7201777.67077.67
380004-8000486.28486.28
486271-8627193.04393.04
594330-94330101.734101.73
681778-8177888.19788.20
10min187951-8795194.85597.554.9095.0097.704.91
285962-8596292.71092.84
387969-8796994.87495.02
494799-94799102.240102.40
597103-97103104.725104.89
688916-8891695.89596.04
15min190100-9010097.17299.523.4997.4799.843.50
291043-9104398.18998.47
389554-8955496.58396.89
495687-95687103.198103.52
597017-97017104.632104.98
690283-9028397.37097.68
20min190658-9065897.774100.393.1298.24100.863.13
292360-9236099.610100.06
391713-9171398.91299.37
496216-96216103.768104.27
597167-97167104.794105.31
690374-9037497.46897.94
30min189914-8991496.972100.203.2297.60100.853.22
292859-92859100.148100.76
391061-9106198.20998.84
496267-96267103.823104.49
596816-96816104.416105.11
690551-9055197.65998.29
45min190015-9001597.08199.993.0997.87100.803.10
292834-92834100.121100.90
390870-9087098.00398.79
495991-95991103.526104.37
596348-96348103.911104.78
690227-9022797.30998.10
极限189859-8985996.91299.713.1897.86100.693.18
292475-9247599.734100.68
390607-9060797.71998.67
495597-95597103.101104.12
596422-96422103.991105.03
689771-8977196.81897.77
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0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.631026691029671030931028821027811028780.16
213.711024751031101027920.44
单位质量响应值RSD%判断
7547.917497.590.48数据可信
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%
5min173055-7305562.95467.9311.4762.9567.9311.46
267539-6753958.20058.20
377901-7790167.13067.13
477553-7755366.83066.83
593898-9389880.91580.91
683043-8304371.56171.56
10min188878-8887876.58980.349.7476.6980.469.74
280399-8039969.28269.38
390513-9051377.99878.11
495276-9527682.10282.21
5107494-10749492.63192.77
696853-9685383.46183.58
15min195958-9595882.69084.208.1582.9284.448.16
286487-8648774.52874.74
392752-9275279.92780.17
498465-9846584.85085.10
5109062-10906293.98294.27
6103512-10351289.19989.46
20min197597-9759784.10287.496.5584.4787.886.56
292859-9285980.01980.36
3101099-10109987.12087.50
499535-9953585.77286.16
5111585-11158596.15696.60
6106497-10649791.77292.18
30min1104065-10406589.67691.963.7290.1992.493.75
2100655-10065586.73787.21
3106839-10683992.06692.59
4107774-10777492.87293.40
5112144-11214496.63897.24
6108797-10879793.75494.31
45min1106625-10662591.88294.172.6392.5494.862.66
2105115-10511590.58191.20
3111171-11117195.79996.47
4109303-10930394.19094.88
5112442-11244296.89597.66
6111046-11104695.69296.41
极限1108027-10802793.09095.991.7693.9096.841.78
2110878-11087895.54796.31
3112894-11289497.28498.12
4110686-11068695.38196.23
5112947-11294797.33098.26
6112947-11294797.33098.21
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%
110.298583885709857498563885754857380.09
210.298570785658856820.05
单位质量响应值RSD%判断
8332.178326.720.05数据可信
供试品溶液-2024021621批-比索洛尔-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%
5min171886-7188677.51883.254.0577.5283.254.05
277934-7793484.04084.04
380812-8081287.14387.14
477617-7761783.69883.70
579294-7929485.50685.51
675642-7564281.56881.57
10min186277-8627793.03695.741.8193.1795.881.81
288504-8850495.43895.58
390837-9083797.95398.10
488456-8845695.38695.53
588433-8843395.36195.50
690188-9018897.25497.39
15min190746-9074697.85598.881.5498.1499.171.54
290930-9093098.05498.35
393535-93535100.863101.17
490933-9093398.05798.36
590537-9053797.63097.93
693471-93471100.794101.09
20min192381-9238199.61899.991.89100.07100.451.88
291389-9138998.54999.01
394785-94785102.211102.69
491668-9166898.85099.31
591089-9108998.22598.69
695017-95017102.461102.93
30min193015-93015100.302100.512.17100.92101.142.17
291520-9152098.69099.32
395372-95372102.844103.49
492068-9206899.28199.91
591264-9126498.41499.04
695998-95998103.519104.16
45min193064-93064100.355100.601.98101.14101.401.97
291594-9159498.77099.56
395218-95218102.678103.50
491900-9190099.10099.89
592064-9206499.277100.07
695908-95908103.422104.23
极限192698-9269899.96099.992.12100.91100.962.12
291158-9115898.30099.26
394888-94888102.322103.31
491561-9156198.73499.69
590737-9073797.84698.80
695336-95336102.805103.79
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0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.631024261020901027711026101024271024650.25
213.711024021030141027080.43
单位质量响应值RSD%判断
7517.617491.470.25数据可信
供试品溶液-2024021621批-氨氯地平-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%
5min122744-2274419.64722.229.6419.6522.229.65
226174-2617422.60922.61
325996-2599622.45622.46
428055-2805524.23424.23
528542-2854224.65524.66
622857-2285719.74419.74
10min151055-5105544.10247.977.1344.1348.017.13
257785-5778549.91649.95
352222-5222245.11045.15
458434-5843450.47650.52
560743-6074352.47152.51
652956-5295645.74445.78
15min159412-5941251.32155.956.5551.4356.066.55
268624-6862459.27859.40
361707-6170753.30353.42
468419-6841959.10159.23
568621-6862159.27659.40
661825-6182553.40553.51
20min163635-6363554.96960.586.5455.1660.796.55
272721-7272162.81763.04
367735-6773558.51058.71
474367-7436764.23964.46
575069-7506964.84665.07
667265-6726558.10558.30
30min168006-6800658.74565.446.8459.0365.756.84
279774-7977468.91069.23
372083-7208362.26662.57
481542-8154270.43770.77
578762-7876268.03668.37
674385-7438564.25564.55
45min175653-7565365.35071.506.1965.7371.926.19
287249-8724975.36775.81
377769-7776967.17867.58
485606-8560673.94874.40
587967-8796775.98776.44
682375-8237571.15771.56
极限197880-9788084.55088.103.0285.0488.643.03
2104996-10499690.69791.26
3100473-10047386.79087.30
4101879-10187988.00588.58
5106105-10610591.65592.23
6100591-10059186.89287.41
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%
110.298564285646857048557885475856090.11
210.298565885614856360.04
单位质量响应值RSD%判断
8319.638322.250.03数据可信
供试品溶液-2024021621批-比索洛尔-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%
5min179317-7931785.61884.951.2185.6284.951.21
279177-7917785.46785.47
378598-7859884.84284.84
479737-7973786.07286.07
578282-7828284.50184.50
677082-7708283.20683.21
10min190516-9051697.70795.922.0297.8596.062.02
288821-8882195.87796.02
391220-9122098.46798.61
488121-8812195.12295.27
588234-8823495.24495.38
686260-8626093.11393.25
15min192921-92921100.30399.151.69100.6199.441.69
290900-9090098.12298.42
394111-94111101.588101.89
491070-9107098.30598.61
592253-9225399.58299.88
689834-8983496.97197.26
20min192780-92780100.15199.841.50100.62100.311.50
291474-9147498.74199.21
394483-94483101.989102.46
492117-9211799.43599.90
593462-93462100.887101.35
690650-9065097.85298.31
30min192806-92806100.179100.341.47100.82100.971.47
291865-9186599.16399.79
395152-95152102.711103.36
492420-9242099.762100.39
593954-93954101.418102.05
691536-9153698.80899.43
45min192768-92768100.13899.861.75100.94100.661.74
291403-9140398.66599.46
394669-94669102.190103.01
492095-9209599.411100.21
593876-93876101.334102.14
690272-9027297.44498.23
极限192051-9205199.36499.371.65100.34100.331.64
291083-9108398.31999.28
394371-94371101.868102.85
491155-9115598.39799.36
593275-93275100.685101.66
690383-9038397.56398.51
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0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.631022901026031024141025741026341025030.15
213.711024151029681026920.39
单位质量响应值RSD%判断
7520.407490.300.29数据可信
供试品溶液-2024021621批-氨氯地平-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%
5min127654-2765423.88524.331.8823.8924.331.87
228106-2810624.27624.28
328109-2810924.27824.28
427964-2796424.15324.15
527993-2799324.17824.18
629190-2919025.21225.21
10min156055-5605548.41648.752.6248.4648.792.62
258215-5821550.28250.32
357625-5762549.77249.81
455627-5562748.04648.09
554145-5414546.76646.81
656978-5697849.21349.26
15min167995-6799558.72958.113.0958.8558.243.09
269575-6957560.09360.22
368890-6889059.50259.63
465437-6543756.51956.64
564171-6417155.42655.54
667627-6762758.41158.53
20min171159-7115961.46261.522.7361.6861.742.73
273779-7377963.72563.95
372291-7229162.43962.66
469341-6934159.89160.11
568621-6862159.26959.48
672161-7216162.32762.55
30min178274-7827467.60767.782.5867.9368.102.58
281796-8179670.64970.98
378637-7863767.92168.25
476977-7697766.48766.80
575925-7592565.57865.89
679250-7925068.45068.78
45min184820-8482073.26172.741.8473.6973.171.84
286145-8614574.40574.85
385385-8538573.74974.19
481865-8186570.70971.13
583473-8347372.09872.52
683613-8361372.21872.66
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