培哚普利氨氯地平片项目信息
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%
110.274120341333412654116541231412390.16
210.184123441301412680.12
单位质量响应值RSD%判断
4015.484053.830.68数据可信
供试品溶液-2022081901批-5mg/5mg规格-培哚普利-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%
5min147366-47366100.16698.121.49100.1798.121.49
247174-4717499.76099.76
346193-4619397.68697.69
445813-4581396.88296.88
545869-4586997.00097.00
645976-4597697.22797.23
10min148377-48377102.30498.772.04103.4299.862.03
247317-47317100.062101.17
346258-4625897.82398.91
446158-4615897.61298.69
546127-4612797.54698.62
646000-4600097.27798.36
15min147863-47863101.21797.923.83103.47100.113.77
248232-48232101.997104.22
346590-4659098.525100.70
443286-4328691.53893.70
546011-4601197.30199.46
645833-4583396.92499.09
20min147872-47872101.23698.162.82104.61101.432.78
247896-47896101.287104.64
344471-4447194.04497.31
446252-4625297.810100.99
546194-4619497.688100.93
645815-4581596.886100.12
30min146794-4679498.95695.035.08103.4699.404.94
247333-47333100.096104.58
345228-4522895.64599.96
440868-4086886.42590.69
544813-4481394.76799.10
644578-4457894.27098.58
45min146137-4613797.56795.192.17103.17100.622.19
246398-4639898.119103.71
344431-4443193.95999.33
444349-4434993.78699.01
544400-4440093.89499.27
644376-4437693.84399.21
极限145315-4531595.82993.871.28102.51100.351.35
244615-4461594.348101.03
344195-4419593.46099.88
443632-4363292.27098.54
544462-4446294.025100.45
644106-4410693.27299.68
培哚普利氨氯地平片项目信息
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0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.471692481691091687701690901687071689850.14
214.321693311692391692850.04
单位质量响应值RSD%判断
11678.3011821.580.87数据可信
供试品溶液-2022081901批-5mg/5mg规格-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%
5min1103525-10352557.11754.606.7257.1254.606.71
285961-8596147.42747.43
398791-9879154.50654.51
4100290-10029055.33355.33
5103751-10375157.24257.24
6101407-10140755.94955.95
10min1141441-14144178.03774.392.6178.6775.002.61
2132199-13219972.93873.46
3135952-13595275.00875.61
4132723-13272373.22773.84
5133958-13395873.90874.54
6132735-13273573.23373.86
15min1150459-15045983.01280.272.1484.5181.712.14
2144550-14455079.75281.09
3147597-14759781.43382.87
4144618-14461879.79081.22
5144275-14427579.60081.06
6141474-14147478.05579.49
20min1155383-15538385.72982.792.0488.1585.122.02
2150758-15075883.17785.40
3149044-14904482.23284.58
4149260-14926082.35184.67
5149881-14988182.69385.03
6146064-14606480.58782.89
30min1153526-15352684.70482.791.7688.0886.041.75
2151031-15103183.32886.48
3151369-15136983.51486.77
4146794-14679480.99084.22
5150574-15057483.07686.34
6147047-14704781.13084.33
45min1156341-15634186.25783.981.7090.5888.141.68
2153520-15352084.70188.77
3152295-15229584.02588.21
4151831-15183183.76987.90
5150325-15032582.93887.12
6148926-14892682.16686.27
极限1162804-16280489.82387.771.9195.1092.871.86
2161785-16178589.26194.28
3158653-15865387.53392.65
4154244-15424485.10090.16
5158966-15896687.70692.81
6158018-15801887.18392.20
培哚普利氨氯地平片项目信息
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%
110.274133241205412844124541324412780.13
210.184138641469414280.15
单位质量响应值RSD%判断
4019.284069.550.88数据可信
供试品溶液-2022081901批-5mg/5mg规格-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%
5min146425-4642597.94197.741.2197.9497.741.21
246144-4614497.34897.35
346302-4630297.68197.68
447304-4730499.79599.80
546228-4622897.52597.53
645582-4558296.16296.16
10min147604-47604100.42899.310.99101.52100.400.99
247234-4723499.648100.73
347124-4712499.416100.50
447444-47444100.091101.20
546612-4661298.33599.42
646429-4642997.94999.02
15min146782-4678298.69497.841.17100.90100.031.17
246842-4684298.821101.01
346307-4630797.69299.88
446732-4673298.589100.81
546170-4617097.40399.58
645420-4542095.82197.98
20min146682-4668298.48396.591.25101.7899.871.23
245934-4593496.905100.19
345423-4542395.82799.10
445801-4580196.62499.94
545898-4589896.829100.09
644978-4497894.88898.11
30min145608-4560896.21795.140.98100.6199.480.96
245065-4506595.07299.44
345606-4560696.213100.55
445023-4502394.98399.37
544686-4468694.27298.61
644582-4458294.05398.33
45min145467-4546795.92094.361.42101.3899.771.39
244400-4440093.66999.09
344862-4486294.643100.05
444809-4480994.53299.98
545178-4517895.310100.69
643663-4366392.11497.43
极限144674-4467494.24791.913.15100.7898.363.00
243505-4350591.78198.24
344047-4404792.92499.38
444519-4451993.920100.42
543722-4372292.23898.68
640927-4092786.34292.69
培哚普利氨氯地平片项目信息
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0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.471688941688941689431690781688111689240.06
214.321692701691821692260.04
单位质量响应值RSD%判断
11674.0811817.460.87数据可信
供试品溶液-2022081901批-5mg/5mg规格-氨氯地平
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min199627-9962754.98654.765.0454.9954.765.04
295965-9596552.96552.97
3105399-10539958.17258.17
4104143-10414357.47957.48
597974-9797454.07454.07
692139-9213950.85450.85
10min1143648-14364879.28376.323.7279.8976.933.72
2135681-13568174.88575.47
3137880-13788076.09976.75
4145204-14520480.14180.78
5135267-13526774.65775.26
6132015-13201572.86273.43
15min1152674-15267484.26480.923.7085.7682.383.69
2145509-14550980.31081.73
3144708-14470879.86881.36
4153598-15359884.77486.30
5143274-14327479.07680.51
6139903-13990377.21678.59
20min1155761-15576185.96882.253.4488.4084.613.43
2147268-14726881.28083.59
3145994-14599480.57782.96
4155246-15524685.68488.15
5145708-14570880.41982.73
6144191-14419179.58281.81
30min1155134-15513485.62283.212.7089.0186.482.73
2148720-14872082.08285.30
3150595-15059583.11786.39
4156259-15625986.24389.67
5147125-14712581.20284.40
6146802-14680281.02384.14
45min1157545-15754586.95383.983.2091.2988.183.21
2150722-15072283.18787.31
3152086-15208683.94088.14
4158031-15803187.22191.60
5148971-14897182.22086.33
6145620-14562080.37184.39
极限1160842-16084288.77287.111.6894.0792.241.77
2156042-15604286.12391.18
3158676-15867687.57792.71
4160825-16082588.76394.11
5155819-15581986.00091.02
6154811-15481185.44490.35
培哚普利氨氯地平片项目信息
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%
110.274137441410412544149541456413980.23
210.184131541424413700.19
单位质量响应值RSD%判断
4030.964063.850.58数据可信
供试品溶液-2022082001批-5mg/5mg规格-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%
5min144785-4478594.40998.682.4794.4198.682.47
247031-4703199.14499.14
347604-47604100.352100.35
446141-4614197.26897.27
547744-47744100.647100.65
647568-47568100.276100.28
10min145834-4583496.62096.946.8297.6798.046.74
247587-47587100.316101.42
339808-3980883.91785.03
446957-4695798.988100.07
548259-48259101.732102.85
647478-47478100.086101.20
15min145521-4552195.96198.531.6598.08100.711.65
246984-4698499.045101.26
346902-4690298.872100.92
446136-4613697.25799.44
547410-4741099.943102.19
647498-47498100.128102.35
20min145074-4507495.01896.851.9998.21100.121.94
246550-4655098.130101.45
346724-4672498.497101.64
444522-4452293.85597.12
546410-4641097.835101.19
646372-4637297.755101.09
30min144310-4431093.40895.561.7197.6599.901.68
245605-4560596.138100.54
345888-4588896.734100.97
444532-4453293.87698.18
546282-4628297.565102.01
645365-4536595.632100.06
45min143777-4377792.28493.841.2297.5799.251.24
244963-4496394.784100.26
344682-4468294.19299.51
443892-4389292.52797.87
544832-4483294.508100.04
644956-4495694.770100.26
极限142822-4282290.27193.332.1596.5899.782.09
245025-4502594.915101.44
344995-4499594.852101.21
443347-4334791.37897.75
544891-4489194.633101.21
644551-4455193.916100.46
培哚普利氨氯地平片项目信息
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0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.471689661685441689911689081690021688820.12
214.321690051689701689880.02
单位质量响应值RSD%判断
11671.1811800.840.79数据可信
供试品溶液-2022082001批-5mg/5mg规格-氨氯地平
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1124832-12483268.95469.603.0968.9569.603.09
2129977-12997771.79671.80
3122597-12259767.72067.72
4129734-12973471.66271.66
5120708-12070866.67666.68
6128188-12818870.80870.81
10min1147043-14704381.22380.297.1281.9981.067.06
2150338-15033883.04383.84
3124574-12457468.81269.56
4150267-15026783.00483.80
5152002-15200283.96284.70
6147933-14793381.71582.50
15min1150407-15040783.08184.050.9684.7585.711.00
2152503-15250384.23985.96
3150495-15049583.13084.65
4152836-15283684.42386.14
5154183-15418385.16786.84
6152509-15250984.24385.94
20min1151066-15106683.44583.701.2386.0486.301.18
2152248-15224884.09886.75
3151973-15197383.94686.39
4148343-14834381.94184.60
5154008-15400885.07187.69
6151552-15155283.71486.34
30min1151104-15110483.46684.301.3186.9987.831.26
2151853-15185383.88087.47
3153230-15323084.64188.01
4150569-15056983.17186.74
5156148-15614886.25389.82
6152757-15275784.38087.94
45min1149442-14944282.54883.640.9586.9988.110.90
2150554-15055483.16387.69
3152278-15227884.11588.43
4150653-15065383.21787.71
5153225-15322584.63889.16
6152365-15236584.16388.66
极限1151217-15121783.52986.332.1988.8991.722.04
2155374-15537485.82591.27
3160258-16025888.52393.77
4154024-15402485.07990.50
5159307-15930787.99893.46
6157514-15751487.00792.44
培哚普利氨氯地平片项目信息
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%
110.274143641288414954149341579414580.27
210.184128141226412540.10
单位质量响应值RSD%判断
4036.814052.460.28数据可信
供试品溶液-2022082001批-5mg/5mg规格-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%
5min145947-4594796.92497.160.8196.9297.160.81
245352-4535295.66995.67
346345-4634597.76397.76
446233-4623397.52797.53
546265-4626597.59597.59
646220-4622097.50097.50
10min146609-4660998.32097.881.4399.4098.961.42
245470-4547095.91896.98
346080-4608097.20498.29
446119-4611997.28798.37
547388-4738899.964101.05
646727-4672798.56999.65
15min144946-4494694.81296.881.5796.9899.041.55
245597-4559796.18698.31
345432-4543295.83798.00
446186-4618697.42899.59
546797-4679798.717100.91
646599-4659998.299100.48
20min145026-4502694.98195.611.4698.2098.861.45
244745-4474594.38897.59
344925-4492594.76898.00
445279-4527995.51598.76
546588-4658898.276101.57
645390-4539095.74999.02
30min144722-4472294.34094.612.0598.6298.922.01
243864-4386492.53096.78
344000-4400092.81797.10
444614-4461494.11298.42
546039-4603997.118101.50
645872-4587296.766101.10
45min143384-4338491.51793.803.1396.8499.153.02
243697-4369792.17897.45
343881-4388192.56697.88
444230-4423093.30298.66
547201-4720199.569105.03
644395-4439593.65099.06
极限143281-4328191.30092.422.1197.6498.822.07
243159-4315991.04397.34
342851-4285190.39396.74
443825-4382592.44898.84
545292-4529295.542102.11
644461-4446193.789100.24
培哚普利氨氯地平片项目信息
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0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.471695701694811695501696041692551694920.09
214.321679021677321678170.08
单位质量响应值RSD%判断
11713.3411719.060.04数据可信
供试品溶液-2022082001批-5mg/5mg规格-氨氯地平
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1119339-11933966.03068.453.5866.0368.453.58
2124988-12498869.15569.16
3131736-13173672.88972.89
4120612-12061266.73466.73
5123601-12360168.38868.39
6121958-12195867.47967.48
10min1147786-14778681.76980.991.4782.5081.751.47
2143111-14311179.18379.95
3149136-14913682.51683.33
4145466-14546680.48681.23
5147390-14739081.55082.31
6145377-14537780.43681.19
15min1147629-14762981.68282.611.5783.3284.271.56
2145530-14553080.52182.17
3150959-15095983.52585.25
4149781-14978182.87384.51
5151912-15191284.05285.72
6150031-15003183.01184.65
20min1150969-15096983.53082.942.0886.0885.522.06
2145737-14573780.63683.18
3152374-15237484.30886.96
4148468-14846882.14784.70
5154096-15409685.26087.86
6147816-14781681.78684.35
30min1153137-15313784.73083.352.6188.2186.852.54
2144214-14421479.79383.23
3151564-15156483.86087.45
4147963-14796381.86785.34
5155073-15507385.80189.35
6151895-15189584.04387.52
45min1149755-14975582.85983.652.8187.2888.082.75
2145626-14562680.57484.90
3153655-15365585.01689.54
4150429-15042983.23287.61
5158106-15810687.47991.98
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