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XXYYYY片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)10供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.944191541806418834182541741418340.17
29.964187141950419100.14
单位质量响应值RSD%判断
4208.654207.830.02数据可信
供试品溶液批-尚未录入-培哚普利-
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min147240-4724095.77795.681.0095.7895.681.00
247292-4729295.88295.88
347667-4766796.64296.64
447682-4768296.67396.67
546697-4669794.67694.68
646581-4658194.44194.44
10min149358-49358100.07198.801.21101.1499.861.20
248097-4809797.51498.58
348744-4874498.82699.90
449442-49442100.241101.32
548656-4865698.64899.70
648086-4808697.49298.54
15min149307-4930799.96798.071.49102.14100.231.48
247518-4751896.34098.49
348529-4852998.390100.56
448811-4881198.962101.15
548553-4855398.439100.59
647513-4751396.33098.46
20min148554-4855498.44197.411.06101.73100.661.06
247500-4750096.30499.52
347914-4791497.143100.41
448749-4874998.836102.12
547988-4798897.293100.54
647576-4757696.45899.66
30min147918-4791897.15196.151.14101.53100.481.13
247045-4704595.38199.67
347042-4704295.37599.72
448258-4825897.841102.23
547326-4732695.951100.27
646958-4695895.20599.48
45min146054-4605493.37293.270.6998.8398.670.70
245924-4592493.10998.46
346151-4615193.56998.97
446413-4641394.10099.57
546032-4603293.32898.72
645456-4545692.16097.49
极限146267-4626793.80492.671.41100.3099.101.38
245419-4541992.08598.47
345668-4566892.59099.03
446642-4664294.564101.08
545339-4533991.92398.35
644902-4490291.03797.39
XXYYYY片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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)10供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.061681641680991680631679961680841680810.04
214.201680401681121680760.04
单位质量响应值RSD%判断
11954.5511836.340.71数据可信
供试品溶液批-尚未录入-氨氯地平片-
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min180291-8029160.68859.032.8260.6959.022.83
276580-7658057.88357.88
380553-8055360.88660.89
479155-7915559.83059.83
576698-7669857.97357.97
675270-7527056.89356.89
10min1129928-12992898.20792.543.2898.8893.193.28
2120628-12062891.17791.82
3122124-12212492.30892.98
4122963-12296392.94293.61
5120698-12069891.23091.87
6118222-11822289.35989.99
15min1147934-147934111.817105.083.34113.58106.763.33
2135908-135908102.727104.38
3138527-138527104.706106.41
4138826-138826104.932106.63
5138048-138048104.344106.00
6134905-134905101.969103.59
20min1153581-153581116.085110.982.34119.09113.842.35
2144639-144639109.326112.12
3146232-146232110.530113.40
4146519-146519110.747113.61
5145767-145767110.179113.00
6144262-144262109.041111.80
30min1159481-159481120.544116.231.94124.84120.321.96
2153082-153082115.708119.72
3151969-151969114.866118.96
4154013-154013116.411120.51
5153035-153035115.672119.71
6151065-151065114.183118.15
45min1156426-156426118.235116.580.83123.87121.960.90
2153703-153703116.177121.48
3154553-154553116.820122.19
4154017-154017116.414121.80
5154195-154195116.549121.88
6152533-152533115.293120.53
极限1161231-161231121.867119.031.48128.82125.701.52
2156738-156738118.471125.06
3157183-157183118.807125.48
4158721-158721119.970126.65
5156674-156674118.423125.04
6154296-154296116.625123.14
XXYYYY片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)10供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.944191141999419994200442037419900.12
29.964231142365423380.10
单位质量响应值RSD%判断
4224.354250.800.45数据可信
供试品溶液批-尚未录入-培哚普利
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min147386-4738695.40995.500.8495.4195.500.84
247687-4768796.01596.01
347080-4708094.79394.79
447484-4748495.60695.61
548016-4801696.67796.68
646934-4693494.49994.50
10min147645-4764595.93096.780.6296.9997.840.62
247972-4797296.58997.66
348179-4817997.00598.06
448262-4826297.17298.23
548476-4847697.60398.68
647874-4787496.39197.44
15min147713-4771396.06796.280.8498.1998.420.83
247747-4774796.13698.28
347600-4760095.84097.97
447318-4731895.27297.41
548468-4846897.58799.75
648060-4806096.76698.89
20min147077-4707794.78795.711.0597.9898.921.03
248337-4833797.323100.53
347172-4717294.97898.17
447637-4763795.91499.11
547837-4783796.31799.56
647155-4715594.94498.14
30min146301-4630193.22494.190.6297.4798.460.61
246881-4688194.39298.68
347054-4705494.74098.99
446767-4676794.16298.43
547061-4706194.75499.07
646626-4662693.87898.13
45min143725-4372588.03792.952.6593.3298.272.53
247074-4707494.780100.12
346614-4661493.85499.16
446754-4675494.13699.45
546456-4645693.53698.90
646376-4637693.37598.67
极限145180-4518090.96792.021.1797.2398.371.14
246684-4668493.995100.39
345462-4546291.53597.88
445604-4560491.82198.18
545884-4588492.38498.79
645400-4540091.41097.74
XXYYYY片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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)10供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.061680241680571682681683521683141682030.10
214.201695521697181696350.07
单位质量响应值RSD%判断
11963.2311946.130.11数据可信
供试品溶液批-尚未录入-氨氯地平片
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min181344-8134461.17860.860.8561.1860.860.85
281286-8128661.13461.13
381604-8160461.37461.37
480801-8080160.77060.77
580840-8084060.79960.80
679677-7967759.92459.92
10min1119451-11945189.83890.731.2190.5291.411.20
2118905-11890589.42790.11
3121327-12132791.24991.93
4122918-12291892.44693.12
5121109-12110991.08591.76
6120105-12010590.33091.00
15min1137438-137438103.366102.012.05105.04103.692.02
2130525-13052598.16799.84
3135807-135807102.139103.84
4134715-134715101.318103.02
5137339-137339103.291104.98
6137951-137951103.752105.42
20min1143807-143807108.156108.720.95110.98111.540.91
2145819-145819109.669112.43
3143400-143400107.850110.68
4146000-146000109.805112.63
5145486-145486109.419112.25
6142866-142866107.448110.27
30min1150775-150775113.397113.340.78117.42117.370.77
2149287-149287112.277116.26
3152062-152062114.364118.39
4150670-150670113.318117.37
5151925-151925114.261118.31
6149509-149509112.444116.46
45min1146978-146978110.541115.662.28115.83120.952.19
2153326-153326115.315120.54
3155964-155964117.299122.60
4156218-156218117.490122.80
5155535-155535116.976122.30
6154716-154716116.360121.63
极限1156485-156485117.691117.770.79124.21124.340.74
2158366-158366119.106125.62
3155333-155333116.825123.43
4156650-156650117.815124.43
5157525-157525118.473125.09
6155208-155208116.731123.29
XXYYYY片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)10供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.944186341948419194195141901419160.09
29.964199841984419910.03
单位质量响应值RSD%判断
4216.904215.960.02数据可信
供试品溶液批-尚未录入-培哚普利
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min150072-50072101.321100.611.54101.32100.601.53
249797-49797100.765100.76
350864-50864102.924102.92
448565-4856598.27298.27
549630-49630100.427100.43
649383-4938399.92799.93
10min151695-51695104.605102.962.10105.73104.082.09
251283-51283103.772104.89
351512-51512104.235105.38
449001-4900199.154100.25
551576-51576104.365105.48
650233-50233101.647102.76
15min151244-51244103.693101.791.99105.98104.051.98
251094-51094103.389105.66
350696-50696102.584104.89
448977-4897799.106101.30
550688-50688102.568104.84
649122-4912299.399101.64
20min150296-50296101.775100.761.83105.21104.161.82
250560-50560102.309105.73
350686-50686102.564106.01
448465-4846598.069101.36
549822-49822100.815104.23
648950-4895099.051102.40
30min149911-49911100.99599.392.03105.57103.902.01
249960-49960101.095105.65
349859-49859100.890105.47
447440-4744095.995100.38
548758-4875898.662103.20
648784-4878498.715103.16
45min149701-49701100.57198.442.09106.26104.062.07
248869-4886998.887104.57
349608-49608100.382106.08
446937-4693794.978100.43
548517-4851798.175103.81
648267-4826797.669103.21
极限149314-4931499.78797.472.24106.60104.182.21
248245-4824597.624104.40
349118-4911899.391106.21
446636-4663694.368100.87
548557-4855798.256104.98
647133-4713395.374102.00
XXYYYY片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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)10供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.061679821680271679531680281681071680190.04
214.201681971680731681350.06
单位质量响应值RSD%判断
11950.1411840.490.66数据可信
供试品溶液批-尚未录入-氨氯地平片
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1131018-13101899.03198.671.6799.0398.671.67
2131224-13122499.18799.19
3133536-133536100.934100.93
4129949-12994998.22398.22
5126838-12683895.87295.87
6130677-13067798.77398.77
10min1168016-168016126.997125.952.03128.10127.052.01
2168050-168050127.022128.12
3169347-169347128.003129.12
4160399-160399121.239122.33
5168809-168809127.596128.66
6165196-165196124.865125.96
15min1172967-172967130.739129.341.75133.25131.841.73
2173144-173144130.873133.39
3172006-172006130.012132.56
4167182-167182126.366128.80
5173886-173886131.433133.92
6167511-167511126.615129.10
20min1171759-171759129.826130.192.00133.79134.131.98
2175009-175009132.282136.25
3176313-176313133.268137.26
4167420-167420126.546130.39
5173755-173755131.334135.28
6169211-169211127.900131.79
30min1174800-174800132.124130.202.21137.53135.572.18
2174032-174032131.544136.98
3175474-175474132.634138.10
4165069-165069124.769130.02
5172469-172469130.362135.76
6171641-171641129.737135.05
45min1173766-173766131.343129.382.22138.22136.212.19
2170874-170874129.157136.06
3175565-175565132.703139.65
4164414-164414124.274130.91
5171629-171629129.727136.58
6170758-170758129.069135.82
极限1175354-175354132.543129.902.71140.88138.162.64
2171417-171417129.567137.90
3176729-176729133.582142.00
4164906-164906124.646132.66
5174745-174745132.083140.38
6167980-167980126.969135.16
XXYYYY片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)10供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.944209641951420224197541980420050.14
29.964194941860419040.16
单位质量响应值RSD%判断
4225.864207.230.32数据可信
供试品溶液批-尚未录入-培哚普利
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min149830-49830100.829100.661.56100.83100.661.57
250054-50054101.283101.28
348572-4857298.28498.28
450918-50918103.031103.03
549350-4935099.85899.86
649749-49749100.666100.67
10min151391-51391103.988103.051.83105.11104.161.83
251543-51543104.296105.42
349347-4934799.852100.94
451525-51525104.259105.40
550212-50212101.602102.71
651538-51538104.286105.40
15min151003-51003103.203101.841.89105.48104.111.88
251250-51250103.703105.99
349158-4915899.470101.67
450747-50747102.685104.99
549103-4910399.358101.60
650724-50724102.638104.92
20min150503-50503102.191100.881.74105.61104.281.74
250332-50332101.845105.28
348648-4864898.438101.74
450680-50680102.549105.99
548893-4889398.933102.28
650084-50084101.343104.76
30min149879-49879100.92999.271.79105.49103.781.78
249645-49645100.455105.02
347606-4760696.329100.73
449750-49750100.668105.25
548686-4868698.515102.96
648780-4878098.705103.25
45min148772-4877298.68998.512.10104.37104.122.07
249809-49809100.787106.47
347031-4703195.166100.64
449697-49697100.560106.26
548340-4834097.814103.35
648440-4844098.017103.66
极限148325-4832597.78497.422.11104.56104.132.08
249050-4905099.251106.06
346662-4666294.419100.95
449183-4918399.520106.34
547191-4719195.490102.11
648455-4845598.047104.78
XXYYYY片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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)10供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.061680651680481682411681861681931681470.06
214.201679001678501678750.03
单位质量响应值RSD%判断
11959.2511822.180.82数据可信
供试品溶液批-尚未录入-氨氯地平片
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1131149-13114999.17098.671.4999.1798.671.49
2131192-13119299.20299.20
3129741-12974198.10598.11
4132983-132983100.557100.56
5130726-13072698.85098.85
6127162-12716296.15596.15
10min1168564-168564127.462126.291.78128.56127.391.77
2168140-168140127.141128.24
3161639-161639122.225123.32
4169333-169333128.043129.16
5165484-165484125.133126.23
6168949-168949127.753128.82
15min1172725-172725130.608129.601.65133.13132.101.64
2173347-173347131.078133.59
3167615-167615126.744129.19
4172549-172549130.475133.01
5168041-168041127.066129.55
6174113-174113131.658134.15
20min1174871-174871132.231130.261.96136.20134.201.94
2172177-172177130.194134.16
3167759-167759126.853130.71
4176055-176055133.126137.12
5168742-168742127.596131.50
6173996-173996131.569135.52
30min1174325-174325131.818130.211.95137.26135.601.92
2173467-173467131.169136.59
3165795-165795125.368130.63
4175132-175132132.428137.90
5171945-171945130.018135.34
6172502-172502130.439135.85
45min1170541-170541128.957129.522.28135.86136.362.23
2174163-174163131.695138.57
3164239-164239124.191130.85
4175423-175423132.648139.59
5171780-171780129.893136.66
6171600-171600129.757136.62
极限1171746-171746129.868129.982.56138.20138.252.50
2174788-174788132.168140.51
3165548-165548125.181133.22
4176913-176913133.775142.19
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