培哚普利左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DPAEA-2-05221204-B对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.87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1.000
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.974203241989419824194841897419700.13
210.034142341385414040.07
单位质量响应值RSD%判断
4209.634128.021.39数据可信
供试品溶液-2024052721批-培哚普利-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%
5min147872-4787299.09199.291.7799.0999.291.77
249220-49220101.881101.88
346600-4660096.45896.46
448298-4829899.97399.97
547809-4780998.96198.96
648011-4801199.37999.38
10min149159-49159101.755101.160.76102.86102.260.76
249459-49459102.376103.51
348759-48759100.927102.00
448732-48732100.871101.98
548460-48460100.308101.41
648650-48650100.702101.81
15min148948-48948101.318100.031.44103.55102.261.40
247661-4766198.654100.92
348307-4830799.992102.18
448998-48998101.422103.65
547341-4734197.992100.21
648707-48707100.820103.04
20min146941-4694197.16498.151.76100.52101.491.70
248427-48427100.240103.61
347935-4793599.222102.53
447297-4729797.901101.26
547813-4781398.969102.27
646088-4608895.39898.74
30min147353-4735398.01797.551.74102.45101.981.68
247464-4746498.247102.73
347455-4745598.228102.63
448192-4819299.754104.20
546265-4626595.765100.17
646037-4603795.29399.70
45min146295-4629595.82795.882.01101.35101.391.92
247225-4722597.752103.32
347185-4718597.669103.17
445644-4564494.479100.03
546715-4671596.696102.16
644861-4486192.85998.32
极限147791-4779198.92495.352.43105.51101.922.30
246390-4639096.024102.68
346051-4605195.322101.91
445666-4566694.525101.13
546142-4614295.510102.05
644340-4434091.78098.27
培哚普利左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100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数8000
标示量(mg)2.5 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%
114.294026740324400634027740224402310.25
214.293963839642396400.01
单位质量响应值RSD%判断
2815.332773.971.05数据可信
供试品溶液-2024052721批-左氨氯地平-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%
5min141945-4194594.76995.580.9394.7795.580.93
242619-4261996.29296.29
342500-4250096.02396.02
441796-4179694.43394.43
542774-4277496.64296.64
642183-4218395.30795.31
10min142015-4201594.92795.511.4495.9896.571.43
243168-4316897.53398.60
342902-4290296.93298.00
441849-4184994.55295.60
541976-4197694.83995.91
641726-4172694.27595.33
15min141610-4161094.01294.410.8296.1296.530.79
241371-4137193.47295.63
342293-4229395.55697.70
442049-4204995.00497.10
541572-4157293.92796.05
641815-4181594.47696.58
20min140046-4004690.47992.832.0093.6396.001.96
241862-4186294.58297.77
341746-4174694.32097.53
440908-4090892.42695.58
541760-4176094.35197.52
640209-4020990.84794.00
30min140624-4062491.78592.261.6095.9496.461.54
240846-4084692.28696.53
341648-4164894.09898.35
441547-4154793.87098.05
540090-4009090.57894.80
640251-4025190.94295.11
45min139887-3988790.12090.922.2895.3096.142.20
241306-4130693.32698.59
341478-4147893.71499.01
439680-3968089.65294.88
539780-3978089.87895.10
639311-3931188.81893.99
极限141130-4113092.92890.942.8199.1197.182.68
240636-4063691.81298.12
341298-4129893.30799.65
439300-3930088.79395.01
540697-4069791.95098.17
638442-3844286.85593.02
培哚普利左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DPAEA-2-05221204-B对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.87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1.000
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.974186941836417754182841869418350.10
210.034186941812418400.10
单位质量响应值RSD%判断
4196.094171.490.42数据可信
供试品溶液-2024052721批-培哚普利-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%
5min149004-49004101.06398.862.01101.0698.862.02
247539-4753998.04198.04
347088-4708897.11197.11
447348-4734897.64797.65
549312-49312101.698101.70
647317-4731797.58497.58
10min148765-48765100.57099.331.75101.69100.421.75
247339-4733997.62998.72
347471-4747197.90198.98
447945-4794598.87999.96
549539-49539102.166103.30
647911-4791198.80999.89
15min148082-4808299.16199.991.20101.40102.201.18
247987-4798798.965101.14
347897-4789798.780100.95
449311-49311101.696103.88
548748-48748100.535102.80
648890-48890100.828103.01
20min147991-4799198.97499.261.15102.32102.581.15
247644-4764498.258101.53
347549-4754998.062101.33
448587-48587100.203103.52
548971-48971100.995104.38
648040-4804099.075102.38
30min147325-4732597.60097.151.05102.04101.571.04
246164-4616495.20699.57
346978-4697896.884101.24
447482-4748297.924102.35
547283-4728397.513102.02
647419-4741997.794102.20
45min147061-4706197.05697.281.79102.58102.781.75
246490-4649095.878101.30
346183-4618395.245100.68
447775-4777598.528104.04
548478-4847899.978105.57
647042-4704297.016102.51
极限146827-4682796.57395.801.11103.18102.381.11
245881-4588194.622101.11
346190-4619095.259101.75
446349-4634995.587102.20
547286-4728697.520104.22
646190-4619095.259101.83
培哚普利左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100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数8000
标示量(mg)2.5 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%
114.294005440148399404018140099400840.24
214.294020340065401340.25
单位质量响应值RSD%判断
2805.042808.540.09数据可信
供试品溶液-2024052721批-左氨氯地平-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%
5min143084-4308496.91694.352.2796.9294.352.27
241745-4174593.90493.90
341457-4145793.25693.26
441114-4111492.48592.48
543171-4317197.11297.11
641090-4109092.43192.43
10min142244-4224495.02794.651.3096.1095.701.31
241365-4136593.05094.09
341876-4187694.19995.24
441927-4192794.31495.34
543022-4302296.77797.86
642026-4202694.53695.56
15min141955-4195594.37795.761.1696.5197.861.11
242360-4236095.28897.37
342445-4244595.47997.56
443316-4331697.43899.51
542356-4235695.27997.43
642985-4298596.69498.77
20min141702-4170293.80895.110.9696.9998.270.94
242485-4248595.56998.70
342074-4207494.64497.79
442453-4245395.49798.66
542861-4286196.41599.63
642106-4210694.71697.87
30min141115-4111592.48792.871.0596.7197.091.00
240597-4059791.32295.52
341684-4168493.76797.96
441505-4150593.36497.58
541089-4108992.42996.71
641716-4171693.83998.04
45min141288-4128892.87693.941.0998.1399.191.07
241451-4145193.24398.46
341534-4153493.43098.67
441996-4199694.46999.73
542541-4254195.695101.01
641750-4175093.91699.16
极限141672-4167293.74093.040.74100.0299.340.70
241109-4110992.47498.72
341587-4158793.54999.82
440976-4097692.17498.48
541632-4163293.650100.02
641202-4120292.68398.97
培哚普利左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DPAEA-2-05221204-B对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.87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1.000
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.974205741985419004196342055419920.16
210.034221941976420980.41
单位质量响应值RSD%判断
4211.844197.210.25数据可信
供试品溶液-2024052721批-培哚普利-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min147031-4703196.51596.971.7896.5196.971.78
245995-4599594.38994.39
346884-4688496.21396.21
448505-4850599.54099.54
547604-4760497.69197.69
647492-4749297.46197.46
10min149211-49211100.989100.331.17102.06101.411.15
249318-49318101.208102.26
349382-49382101.339102.41
448837-48837100.221101.33
547858-4785898.21299.30
648736-48736100.014101.10
15min149132-49132100.826100.120.68103.02102.310.66
249189-49189100.943103.12
348648-4864899.833102.03
448825-48825100.196102.42
548583-4858399.700101.88
648346-4834699.213101.41
20min149113-49113100.78798.391.32104.10101.701.28
247983-4798398.469101.76
347634-4763497.752101.06
448000-4800098.503101.84
547292-4729297.050100.33
647656-4765697.797101.09
30min147919-4791998.33798.601.00102.77103.000.97
248208-4820898.930103.32
347431-4743197.336101.73
448878-48878100.305104.73
547877-4787798.251102.61
647979-4797998.460102.84
45min146949-4694996.34795.490.84101.87100.980.82
246235-4623594.881100.37
346630-4663095.692101.16
446837-4683796.117101.66
545913-4591394.22199.68
646616-4661695.663101.14
极限146185-4618594.77991.019.04101.3897.578.45
245780-4578093.948100.49
345993-4599394.385100.92
446656-4665695.745102.36
545266-4526692.89399.39
636221-3622174.33180.87
培哚普利左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100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数8000
标示量(mg)2.5 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%
114.294026740223405224039340501403810.34
214.294028640042401640.43
单位质量响应值RSD%判断
2825.822810.640.39数据可信
供试品溶液-2024052721批-左氨氯地平-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min111802-1180226.44123.1110.2626.4423.1110.26
28625-862519.32319.32
39790-979021.93321.93
410381-1038123.25723.26
510751-1075124.08624.09
610548-1054823.63123.63
10min121219-2121947.53845.573.2147.8345.833.21
220501-2050145.93046.14
320070-2007044.96445.21
419558-1955843.81744.08
519780-1978044.31444.58
620918-2091846.86447.13
15min124327-2432754.50151.753.9655.3252.523.93
223878-2387853.49554.22
322827-2282751.14151.88
421829-2182948.90549.65
522512-2251250.43551.19
623234-2323452.05252.84
20min125249-2524956.56754.993.2357.9956.333.19
225475-2547557.07358.39
324123-2412354.04455.36
424586-2458655.08156.37
523282-2328252.16053.48
624567-2456755.03956.40
30min128260-2826063.31360.503.9465.3762.453.90
228188-2818863.15165.10
325749-2574957.68759.60
426468-2646859.29861.20
526131-2613158.54360.44
627227-2722760.99862.97
45min129385-2938565.83362.793.6068.5965.413.57
228775-2877564.46667.12
327829-2782962.34764.90
427115-2711560.74763.31
526724-2672459.87162.42
628327-2832763.46366.11
极限133285-3328574.57069.9112.6478.0673.2312.06
233326-3332674.66278.03
333318-3331874.64477.89
432259-3225972.27275.51
531786-3178671.21274.43
623264-2326452.12055.48
培哚普利左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DPAEA-2-05221204-B对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.87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1.000
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.974033440285402064025040224402600.13
210.034045940498404780.07
单位质量响应值RSD%判断
4038.114035.690.05数据可信
供试品溶液-2024052721批-培哚普利-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min146965-46965100.38198.312.01100.3898.302.01
246929-46929100.304100.30
345694-4569497.66497.66
446330-4633099.02499.02
545455-4545597.15497.15
644594-4459495.31395.31
10min148175-48175102.967100.851.53104.08101.941.53
247371-47371101.249102.36
347238-47238100.964102.05
447585-47585101.706102.81
546179-4617998.70199.78
646564-4656499.524100.58
15min146533-4653399.45899.540.97101.72101.760.96
246034-4603498.391100.63
346492-4649299.370101.58
447263-47263101.018103.25
546904-46904100.251102.43
646205-4620598.757100.92
20min146878-46878100.19599.070.99103.56102.390.99
246187-4618798.718102.05
346070-4607098.468101.78
446968-46968100.387103.74
545871-4587198.043101.33
646149-4614998.637101.90
30min145700-4570097.67798.060.79102.15102.470.78
245758-4575897.801102.23
345723-4572397.726102.13
446462-4646299.306103.77
546152-4615298.643103.02
645467-4546797.179101.54
45min145368-4536896.96894.361.87102.5399.861.80
243855-4385593.73499.25
344153-4415394.37199.86
444435-4443594.973100.54
542830-4283091.54397.02
644234-4423494.54499.98
极限145134-4513496.46794.081.59103.11100.641.55
243848-4384893.719100.28
343777-4377793.567100.11
444419-4441994.939101.57
543853-4385393.729100.22
643058-4305892.03098.52
培哚普利左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100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数8000
标示量(mg)2.5 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%
114.293873638741387523875638713387400.05
214.293877038705387380.12
单位质量响应值RSD%判断
2710.992710.850.01数据可信
供试品溶液-2024052721批-左氨氯地平-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min110200-1020023.75623.126.9723.7623.126.97
210983-1098325.58025.58
310051-1005123.40923.41
49521-952122.17522.17
58918-891820.77020.77
69901-990123.06023.06
10min119583-1958345.60945.622.3345.8745.882.32
219237-1923744.80345.09
320317-2031747.31947.58
418994-1899444.23844.48
519756-1975646.01246.24
619650-1965045.76546.02
15min121934-2193451.08551.213.7451.8651.983.67
220770-2077048.37449.16
322417-2241752.21053.00
421288-2128849.58050.32
522760-2276053.00953.75
622768-2276853.02753.79
20min123491-2349154.71155.604.1556.0556.934.08
222612-2261252.66453.98
324559-2455957.19958.56
422959-2295953.47254.76
525041-2504158.32159.65
624569-2456957.22258.58
30min124656-2465657.42460.185.0159.3762.134.92
224293-2429356.57958.48
326636-2663662.03664.04
425355-2535559.05260.94
527684-2768464.47766.46
626399-2639961.48463.47
45min126162-2616260.93260.894.6063.5263.514.53
224676-2467657.47160.00
326965-2696562.80265.49
424669-2466957.45559.99
527175-2717563.29165.99
627215-2721563.38466.06
极限130293-3029370.55371.073.3373.8174.373.30
229023-2902367.59570.77
331040-3104072.29375.68
430273-3027370.50773.68
532104-3210474.77178.17
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