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%
110.078383483836838218376883766838050.05
210.068385583850838520.01
单位质量响应值RSD%判断
8322.248335.190.11数据可信
供试品溶液-2024021821批-比索洛尔-0.005hcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min192191-9219199.42297.761.6699.4297.761.66
289767-8976796.80896.81
391294-9129498.45598.45
489158-8915896.15196.15
589080-8908096.06796.07
692395-9239599.64299.64
10min195087-95087102.545100.671.70102.71100.841.70
293847-93847101.208101.37
392697-9269799.968100.13
490640-9064097.75097.91
593255-93255100.570100.73
694575-94575101.993102.16
15min194950-94950102.398100.821.80102.73101.151.79
294535-94535101.950102.28
393014-93014100.310100.64
490449-9044997.54497.87
593322-93322100.642100.97
694632-94632102.055102.39
20min194887-94887102.330100.781.71102.84101.281.71
294477-94477101.888102.39
392705-9270599.977100.47
490649-9064997.75998.25
593449-93449100.779101.27
694515-94515101.929102.43
30min194943-94943102.390100.571.72103.07101.241.72
294310-94310101.707102.38
392581-9258199.843100.51
490468-9046897.56498.21
593156-93156100.463101.13
694056-94056101.434102.11
45min194842-94842102.281100.501.80103.13101.331.80
294311-94311101.709102.55
392324-9232499.566100.40
490326-9032697.41198.22
593144-93144100.450101.28
694187-94187101.575102.42
极限194394-94394101.798100.221.78102.82101.221.78
294109-94109101.491102.50
392322-9232299.564100.56
489950-8995097.00697.98
592969-92969100.261101.26
693841-93841101.202102.22
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%
113.851028631028831031371027461027041028670.17
213.971030461032311031380.13
单位质量响应值RSD%判断
7427.227382.820.43数据可信
供试品溶液-2024021821批-氨氯地平-0.005hcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1102794-10279489.98990.963.4189.9990.963.40
2100030-10003087.56987.57
3106374-10637493.12393.12
4109739-10973996.06996.07
5101777-10177789.09989.10
6102684-10268489.89389.89
10min1109889-10988996.20096.761.9296.3596.911.92
2109745-10974596.07496.22
3110392-11039296.64096.80
4114442-114442100.186100.35
5110617-11061796.83796.99
6108075-10807594.61294.76
15min1110402-11040296.64997.631.7696.9697.951.76
2111786-11178697.86198.17
3111567-11156797.66997.99
4114722-114722100.431100.76
5111886-11188697.94898.26
6108803-10880395.24995.56
20min1110298-11029896.55898.081.9997.0398.561.99
2113009-11300998.93199.40
3111621-11162197.71698.20
4115242-115242100.886101.38
5113086-11308698.99999.47
6108985-10898595.40995.87
30min1111435-11143597.55398.382.2798.1999.022.26
2114204-11420499.977100.61
3111938-11193897.99498.64
4115487-115487101.101101.76
5113040-11304098.95899.60
6108153-10815394.68095.31
45min1110415-11041596.66098.422.4797.4699.222.46
2115903-115903101.465102.27
3111775-11177597.85198.66
4114882-114882100.571101.40
5113027-11302798.94799.75
6108515-10851594.99795.78
极限1110735-11073596.94198.512.4397.9099.482.42
2115889-115889101.453102.42
3111440-11144097.55898.53
4114853-114853100.546101.54
5113592-11359299.442100.41
6108647-10864795.11396.05
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%
110.078385683884837648383583795838270.06
210.068386583904838840.04
单位质量响应值RSD%判断
8324.438338.370.12数据可信
供试品溶液-2024021821批-比索洛尔-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%
5min179857-7985786.09389.492.5286.0989.492.52
281379-8137987.73487.73
383466-8346689.98489.98
483255-8325589.75689.76
585624-8562492.31092.31
684459-8445991.05491.05
10min189354-8935496.33296.980.8096.4897.130.80
289314-8931496.28996.43
389545-8954596.53896.69
489894-8989496.91497.06
591065-9106598.17698.33
690550-9055097.62197.77
15min189600-8960096.59797.720.9396.9098.030.93
290057-9005797.09097.40
390467-9046797.53297.84
490499-9049997.56697.88
591916-9191699.09499.41
691289-9128998.41898.73
20min189815-8981596.82997.781.0097.2998.251.00
290140-9014097.17997.65
390691-9069197.77398.25
490515-9051597.58398.06
592406-9240699.622100.10
690601-9060197.67698.15
30min189900-8990096.92098.141.0097.5598.781.00
290463-9046397.52798.16
391040-9104098.14998.79
490980-9098098.08598.72
592592-9259299.823100.47
691227-9122798.35198.99
45min189439-8943996.42397.771.1397.2198.571.13
289866-8986696.88497.68
390559-9055997.63198.43
490711-9071197.79598.59
592317-9231799.526100.34
691257-9125798.38399.19
极限188835-8883595.77297.131.1796.7298.091.17
289055-8905596.00996.96
390158-9015897.19998.16
490076-9007697.11098.07
591600-9160098.75399.73
690856-9085697.95198.92
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%
113.851030181027151026541027631029621028220.16
213.971026451028511027480.15
单位质量响应值RSD%判断
7423.977354.900.67数据可信
供试品溶液-2024021821批-氨氯地平-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%
5min182362-8236272.25576.964.1672.2676.964.15
284246-8424673.90873.91
391650-9165080.40380.40
490305-9030579.22379.22
589506-8950678.52278.52
688270-8827077.43877.44
10min198501-9850186.41488.801.8286.5388.931.82
299563-9956387.34587.47
3102328-10232889.77189.90
4103431-10343190.73990.87
5101922-10192289.41589.55
6101610-10161089.14189.27
15min1101027-10102788.63090.551.8988.8990.831.89
2100510-10051088.17688.44
3104744-10474491.89092.17
4105003-10500392.11892.40
5103999-10399991.23791.52
6104042-10404291.27591.55
20min1102026-10202689.50690.681.6289.9291.101.62
2101157-10115788.74489.16
3104793-10479391.93392.37
4104740-10474091.88792.32
5104969-10496992.08892.52
6102469-10246989.89590.32
30min1101121-10112188.71290.652.4489.2791.232.44
2101228-10122888.80689.37
3106349-10634993.29993.89
4105210-10521092.29992.89
5105229-10522992.31692.90
6100838-10083888.46489.04
45min1100792-10079288.42390.922.2589.1391.652.25
2100641-10064188.29189.00
3105598-10559892.64093.39
4105811-10581192.82793.57
5104538-10453891.71092.45
6104472-10447291.65292.38
极限1101276-10127688.84890.861.6289.7091.741.63
2101751-10175189.26590.12
3105492-10549292.54793.45
4104625-10462591.78692.68
5104287-10428791.49092.38
6103958-10395891.20192.08
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%
110.078354983537835798353383526835450.03
210.068342483422834230.01
单位质量响应值RSD%判断
8296.438292.540.04数据可信
供试品溶液-2024021821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%
5min192396-92396100.05599.591.41100.0599.591.41
290479-9047997.97997.98
391191-9119198.75098.75
490924-9092498.46198.46
593605-93605101.364101.36
693227-93227100.954100.95
10min194126-94126101.928100.851.22102.09101.021.22
291499-9149999.08399.25
392383-92383100.040100.21
492599-92599100.274100.44
594350-94350102.171102.34
693813-93813101.589101.76
15min193575-93575101.331100.741.10101.67101.081.10
291521-9152199.10799.44
392712-92712100.397100.73
492343-9234399.997100.33
594228-94228102.038102.38
693812-93812101.588101.93
20min193377-93377101.117100.621.25101.62101.121.24
291120-9112098.67399.17
392389-92389100.047100.55
492515-92515100.183100.68
594349-94349102.169102.68
693760-93760101.532102.04
30min193453-93453101.199100.651.16101.87101.321.16
291042-9104298.58899.25
392903-92903100.604101.27
492561-92561100.233100.90
593949-93949101.736102.42
693792-93792101.566102.24
45min193514-93514101.265100.440.98102.11101.280.98
291415-9141598.99299.81
392636-92636100.314101.15
492028-9202899.656100.49
593732-93732101.501102.35
693196-93196100.921101.77
极限193014-93014100.72499.991.14101.74100.991.14
290822-9082298.35099.34
392048-9204899.678100.68
491493-9149399.077100.07
593160-93160100.882101.90
693467-93467101.214102.23
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%
113.851025071024171023861024001024281024280.05
213.971021641020671021160.07
单位质量响应值RSD%判断
7395.527309.660.83数据可信
供试品溶液-2024021821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%
5min1105214-10521492.76694.812.1592.7794.822.15
2111268-11126898.10498.10
3105650-10565093.15193.15
4107598-10759894.86894.87
5109085-10908596.18096.18
6106408-10640893.81993.82
10min1114600-114600101.04299.461.99101.2099.611.99
2115108-115108101.490101.65
3111449-11144998.26498.42
4113094-11309499.71499.87
5113516-113516100.086100.25
6109033-10903396.13496.29
15min1114810-114810101.22799.621.59101.5599.951.59
2114888-114888101.296101.63
3111465-11146598.27898.60
4112603-11260399.28199.61
5113654-113654100.208100.54
6110507-11050797.43397.75
20min1114277-114277100.75799.811.40101.25100.301.40
2114217-114217100.704101.21
3111982-11198298.73499.22
4114758-114758101.181101.67
5113320-11332099.913100.41
6110668-11066897.57598.05
30min1114458-114458100.91799.141.64101.5899.791.64
2112433-11243399.13199.80
3111525-11152598.33198.98
4114571-114571101.016101.67
5111901-11190198.66299.32
6109749-10974996.76597.41
45min1114962-114962101.36199.351.98102.19100.171.98
2114388-114388100.855101.69
3111248-11124898.08798.90
4114076-114076100.580101.41
5112263-11226398.98299.81
6109140-10914096.22897.03
极限1114738-114738101.16499.431.72102.16100.421.72
2114365-114365100.835101.84
3111211-11121198.05499.03
4114257-114257100.740101.73
5111968-11196898.72199.71
6110119-11011997.09198.05
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%
110.078360983706836148364283632836410.05
210.068364783709836780.06
单位质量响应值RSD%判断
8305.968317.890.11数据可信
供试品溶液-2024021821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%
5min187952-8795295.04294.013.2395.0494.013.23
284364-8436491.16591.17
385198-8519892.06692.07
488714-8871495.86695.87
591324-9132498.68698.69
684433-8443391.24091.24
10min190109-9010997.37396.692.8297.5396.842.82
287467-8746794.51894.67
387732-8773294.80594.96
490474-9047497.76897.93
593776-93776101.336101.50
687277-8727794.31394.47
15min190377-9037797.66397.822.5597.9898.132.55
288614-8861495.75896.07
389038-8903896.21696.53
491568-9156898.95099.27
594629-94629102.258102.59
688881-8888196.04696.36
20min190444-9044497.73598.142.3898.2298.622.38
289241-8924196.43596.90
390222-9022297.49597.97
491272-9127298.63099.12
594854-94854102.501103.00
688892-8889296.05896.53
30min191019-9101998.35798.862.3199.0099.512.31
290080-9008097.34297.97
390301-9030197.58198.22
491841-9184199.24599.90
595566-95566103.270103.94
690120-9012097.38598.01
45min190978-9097898.31298.922.2299.1299.732.23
290028-9002897.28698.08
390498-9049897.79498.59
491838-9183899.242100.06
595493-95493103.191104.04
690429-9042997.71998.51
极限190961-9096198.29498.732.2699.2799.702.26
289854-8985497.09898.05
390493-9049397.78898.75
491441-9144198.81399.80
595387-95387103.077104.10
690043-9004397.30298.26
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)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%
113.851024341023461023951023651024681024020.05
213.971028291026921027600.10
单位质量响应值RSD%判断
7393.657355.760.37数据可信
供试品溶液-2024021821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%
5min161024-6102453.64252.981.9853.6452.981.98
259000-5900051.86351.86
358738-5873851.63251.63
461793-6179354.31854.32
560736-6073653.38853.39
660368-6036853.06553.07
10min180700-8070070.93769.502.4971.0369.592.48
277365-7736568.00668.09
376632-7663267.36167.45
481675-8167571.79471.88
578324-7832468.84968.94
679682-7968270.04370.13
15min188641-8864177.91875.802.7878.1376.002.77
284363-8436374.15774.36
382682-8268272.68072.88
488401-8840177.70777.92
585761-8576175.38675.59
687539-8753976.94977.15
20min191583-9158380.50478.862.3280.8479.192.32
288754-8875478.01778.34
386396-8639675.94476.26
492066-9206680.92881.27
589185-8918578.39678.73
690273-9027379.35279.69
30min195075-9507583.57381.252.5784.0581.712.57
291126-9112680.10280.56
389525-8952578.69579.14
495550-9555083.99184.47
591522-9152280.45080.91
691763-9176380.66281.13
45min197327-9732785.55383.472.9586.1684.072.95
293884-9388482.52683.11
389928-8992879.04979.63
496703-9670385.00485.62
594925-9492583.44284.04
696982-9698285.25085.85
极限1106245-10624593.39294.111.7994.1594.851.79
2106917-10691793.98394.71
3104764-10476492.09092.80
4108931-10893195.75396.51
5105773-10577392.97793.71
6109744-10974496.46897.21
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