培哚普利左氨氯地平项目信息
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%
19.604124741223411964116741110411890.13
29.584105141054410520.01
单位质量响应值RSD%判断
4290.524285.180.09数据可信
长期3月-供试品溶液-24050602批-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%
5min148431-4843197.45699.741.7497.4699.741.74
249561-4956199.73099.73
349957-49957100.527100.53
450887-50887102.398102.40
549697-49697100.004100.00
648860-4886098.31998.32
10min147933-4793396.45499.292.0897.54100.402.07
249261-4926199.126100.23
349483-4948399.573100.69
451082-51082102.791103.93
549382-4938299.370100.48
648906-4890698.41299.50
15min147548-4754895.67998.382.1297.83100.592.11
248831-4883198.261100.47
349594-4959499.796102.02
450261-50261101.139103.42
549232-4923299.068101.28
647874-4787496.33598.52
20min147410-4741095.40297.601.7598.62100.901.76
248460-4846097.515100.82
348913-4891398.426101.76
449795-49795100.201103.60
548654-4865497.905101.22
647768-4776896.12299.38
30min146987-4698794.55095.952.5298.83100.342.48
246997-4699794.57198.96
348878-4887898.356102.78
449520-4952099.648104.16
546990-4699094.55698.96
646709-4670993.99198.32
45min146210-4621092.98794.971.8198.32100.421.81
247439-4743995.460100.90
347899-4789996.386101.90
448314-4831497.221102.84
547018-4701894.613100.07
646288-4628893.14498.51
极限146199-4619992.96594.031.9699.33100.541.94
246111-4611192.78899.28
347052-4705294.681101.27
448459-4845997.513104.22
546270-4627093.10899.61
646277-4627793.12299.53
培哚普利左氨氯地平项目信息
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%
113.693824838181380903812238254381790.20
213.653838538404383940.04
单位质量响应值RSD%判断
2788.822812.750.61数据可信
长期3月-供试品溶液-24050602批-左氨氯地平-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%
5min133021-3302174.44077.292.3774.4477.292.37
234353-3435377.44377.44
333883-3388376.38476.38
435313-3531379.60779.61
534958-3495878.80778.81
634191-3419177.07877.08
10min138047-3804785.77187.021.4586.6087.881.45
238306-3830686.35587.22
338166-3816686.03986.89
439320-3932088.64089.53
539265-3926588.51789.39
638513-3851386.82187.68
15min138157-3815786.01987.622.1487.8089.452.12
237772-3777285.15186.97
339415-3941588.85590.66
439364-3936488.74090.61
539924-3992490.00291.86
638581-3858186.97588.80
20min138816-3881687.50487.781.4990.2490.581.49
238089-3808985.86588.63
339213-3921388.39991.19
439165-3916588.29191.15
539763-3976389.63992.50
638576-3857686.96389.75
30min138494-3849486.77886.871.9390.4990.651.89
237639-3763984.85188.57
339370-3937088.75392.53
439335-3933588.67492.51
538623-3862387.06990.92
637756-3775685.11588.87
45min138536-3853686.87386.811.5391.5591.551.51
237782-3778285.17389.84
338805-3880587.48092.24
438975-3897587.86392.68
539142-3914288.23993.06
637816-3781685.25089.95
极限139165-3916588.29190.201.6293.9395.901.57
239444-3944488.92094.53
340420-4042091.12096.85
440790-4079091.95497.75
539767-3976789.64895.45
640489-4048991.27696.92
培哚普利左氨氯地平项目信息
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%
19.604112841120411294107741112411130.06
29.584133141421413760.16
单位质量响应值RSD%判断
4282.604319.000.60数据可信
长期3月-供试品溶液-24050701批-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%
5min150415-50415101.14599.371.34101.1499.361.34
248564-4856497.43197.43
350041-50041100.394100.39
449635-4963599.58099.58
549096-4909698.49998.50
649423-4942399.15599.15
10min150041-50041100.39498.811.38101.5299.921.37
248228-4822896.75797.84
348678-4867897.66098.78
449478-4947899.265100.37
549738-4973899.787100.88
649351-4935199.010100.11
15min149579-4957999.46897.331.68101.7199.541.66
247088-4708894.47096.63
348760-4876097.824100.03
448726-4872697.75699.97
548520-4852097.34399.55
648419-4841997.14099.34
20min148848-4884898.00196.561.27101.3599.851.27
247056-4705694.40697.61
348179-4817996.65999.95
448546-4854697.395100.69
548083-4808396.46699.75
648073-4807396.44699.73
30min147967-4796796.23394.712.10100.6799.062.06
245243-4524390.76895.02
347609-4760995.51599.88
447704-4770495.706100.08
547343-4734394.98299.34
647375-4737595.04699.40
45min147154-4715494.60294.001.07100.1199.401.08
245878-4587892.04297.31
347218-4721894.731100.15
446950-4695094.19399.63
547083-4708394.46099.87
646825-4682593.94299.35
极限147438-4743895.17293.341.24101.7399.791.24
245706-4570691.69797.98
346516-4651693.32299.80
446308-4630892.90599.39
546794-4679493.880100.34
646386-4638693.06299.51
培哚普利左氨氯地平项目信息
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%
113.693843838423384773844638474384520.07
213.653846538406384360.11
单位质量响应值RSD%判断
2808.772815.820.18数据可信
长期3月-供试品溶液-24050701批-左氨氯地平-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%
5min137743-3774384.73682.762.4484.7482.762.44
235994-3599480.80980.81
336102-3610281.05281.05
436727-3672782.45582.45
538170-3817085.69485.69
636439-3643981.80881.81
10min139977-3997789.75186.763.9990.6987.683.97
237424-3742484.02084.92
336666-3666682.31883.22
438690-3869086.86287.78
540783-4078391.56192.51
638321-3832186.03386.94
15min140086-4008689.99686.393.4791.9388.273.46
236975-3697583.01284.84
337557-3755784.31886.13
438297-3829785.98087.86
540131-4013190.09792.07
637838-3783884.94986.81
20min139931-3993189.64886.193.2292.5989.043.22
237082-3708283.25286.01
337225-3722583.57386.32
438360-3836086.12188.96
539794-3979489.34092.31
637955-3795585.21288.02
30min139004-3900487.56785.223.3491.5089.023.32
236006-3600680.83684.51
337499-3749984.18887.87
438240-3824085.85289.65
539554-3955488.80292.76
637452-3745284.08287.84
45min139185-3918587.97385.842.4792.8890.592.50
236814-3681482.65087.23
337953-3795385.20789.82
438086-3808685.50690.25
539401-3940188.45893.41
637976-3797685.25989.95
极限140018-4001889.84388.381.6895.7394.081.77
238690-3869086.86292.36
338899-3889987.33192.89
439310-3931088.25493.95
540322-4032290.52696.46
638964-3896487.47793.11
培哚普利左氨氯地平项目信息
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%
19.604136941353413724132941320413490.06
29.584138741383413850.01
单位质量响应值RSD%判断
4307.194319.940.21数据可信
长期3月-供试品溶液-24050702批-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%
5min148870-4887097.75498.711.3797.7598.701.37
249385-4938598.78498.78
348718-4871897.44997.45
450224-50224100.462100.46
550090-50090100.194100.19
648789-4878997.59297.59
10min148208-4820896.42998.351.8497.5299.441.83
249765-4976599.544100.64
348289-4828996.59197.67
450187-50187100.388101.50
549962-4996299.938101.05
648588-4858897.18998.27
15min147736-4773695.48596.981.6597.6499.171.65
249006-4900698.026100.23
347616-4761695.24597.40
449500-4950099.014101.25
549049-4904998.112100.34
647980-4798095.97398.14
20min147326-4732694.66595.951.8897.8899.221.87
248356-4835696.725100.02
346669-4666993.35196.57
448973-4897397.960101.29
548804-4880497.622100.94
647693-4769395.39998.63
30min146505-4650593.02394.381.3997.2998.721.40
247571-4757195.15599.52
346653-4665393.31997.57
448036-4803696.085100.51
547679-4767995.37199.77
646664-4666493.34197.63
45min146308-4630892.62993.581.3597.9398.961.36
246990-4699093.99399.42
346076-4607692.16597.45
447547-4754795.107100.60
547432-4743294.877100.34
646344-4634492.70198.03
极限145644-4564491.30192.241.2297.6398.661.25
246458-4645892.92999.40
345521-4552191.05597.37
446715-4671593.44399.99
546676-4667693.36599.88
645654-4565491.32197.68
培哚普利左氨氯地平项目信息
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%
113.693850738477384593842138463384650.09
213.653847438639385560.31
单位质量响应值RSD%判断
2809.722824.620.38数据可信
长期3月-供试品溶液-24050702批-左氨氯地平-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%
5min135653-3565379.90678.982.3679.9178.982.37
234850-3485078.10678.11
335838-3583880.32080.32
433836-3383675.83375.83
536129-3612980.97280.97
635121-3512178.71378.71
10min137322-3732283.64681.192.9284.5382.062.88
236146-3614681.01181.88
337225-3722583.42984.32
435699-3569980.00980.85
534489-3448977.29778.20
636466-3646681.72882.60
15min137152-3715283.26582.132.4185.0883.912.38
236389-3638981.55583.32
336908-3690882.71884.54
435178-3517878.84180.57
537783-3778384.67986.44
636467-3646781.73083.51
20min137199-3719983.37181.912.7786.1184.602.73
236420-3642081.62584.30
336692-3669282.23484.97
434850-3485078.10680.71
537848-3784884.82587.52
636280-3628081.31184.00
30min136747-3674782.35880.912.4386.0384.512.41
236052-3605280.80084.38
336352-3635281.47285.12
434585-3458577.51280.99
537082-3708283.10886.75
635786-3578680.20483.80
45min136774-3677482.41881.042.4387.0085.542.40
235429-3542979.40483.88
336757-3675782.38086.94
435098-3509878.66283.00
537248-3724883.48088.05
635647-3564779.89284.38
极限138891-3889187.16386.193.3292.6691.593.23
237989-3798985.14190.50
339874-3987489.36694.84
436161-3616181.04486.25
538848-3884887.06692.56
638975-3897587.35192.72
培哚普利左氨氯地平项目信息
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%
19.604142141485414824141041453414500.09
29.584146641429414480.07
单位质量响应值RSD%判断
4317.714326.510.15数据可信
长期3月-供试品溶液-2024052721批-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%
5min150363-50363100.54198.441.35100.5498.441.35
249660-4966099.13799.14
348473-4847396.76896.77
448800-4880097.42097.42
549240-4924098.29998.30
649335-4933598.48898.49
10min148285-4828596.39298.010.8497.5199.100.82
249296-4929698.41199.51
349351-4935198.52099.60
449283-4928398.38599.47
549059-4905997.93799.03
649284-4928498.38799.48
15min148583-4858396.98796.890.6899.1899.080.67
248451-4845196.72498.92
348648-4864897.11799.29
447943-4794395.70997.89
548919-4891997.65899.84
648666-4866697.15399.34
20min148657-4865797.13596.180.89100.4099.440.87
248762-4876297.344100.61
347809-4780995.44298.69
447812-4781295.44898.69
548116-4811696.05599.32
647908-4790895.64098.91
30min147594-4759495.01394.411.2199.3698.741.17
248009-4800995.841100.19
347593-4759395.01199.32
446795-4679593.41897.72
546461-4646192.75197.08
647296-4729694.41898.75
45min147237-4723794.30093.440.6899.7098.820.65
246498-4649892.82598.24
347125-4712594.07699.44
446475-4647592.77998.12
546709-4670993.24698.61
646788-4678893.40498.78
极限146874-4687493.57592.610.84100.0299.020.81
246807-4680793.44299.89
346407-4640792.64399.05
445920-4592091.67198.04
546093-4609392.01698.42
646229-4622992.28898.70
培哚普利左氨氯地平项目信息
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%
113.693866738465384863841038403384860.28
213.653869838655386760.08
单位质量响应值RSD%判断
2811.252833.410.56数据可信
长期3月-供试品溶液-2024052721批-左氨氯地平-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%
5min134081-3408176.24374.482.1076.2474.482.10
234118-3411876.32676.33
332822-3282273.42773.43
432367-3236772.40972.41
533292-3329274.47874.48
633078-3307874.00074.00
10min136180-3618080.93979.781.6481.7980.611.65
236421-3642181.47882.33
335826-3582680.14780.96
434887-3488778.04778.85
535419-3541979.23780.06
635244-3524478.84579.67
15min135247-3524778.85279.201.5280.6080.921.52
236110-3611080.78382.54
335558-3555879.54881.25
434549-3454977.29078.96
535752-3575279.98281.69
635206-3520678.76080.46
20min136022-3602280.58679.402.1183.2182.002.10
236574-3657481.82184.47
335581-3558179.59982.19
434557-3455777.30879.84
535412-3541279.22181.82
634813-3481377.88180.45
30min135663-3566379.78378.592.4283.3082.072.38
236211-3621181.00884.57
335763-3576380.00683.48
434226-3422676.56879.96
534333-3433376.80780.28
634584-3458477.36980.81
45min135855-3585580.21278.701.2584.6283.061.25
235155-3515578.64683.11
335517-3551779.45683.82
434656-3465677.53081.77
534991-3499178.27982.61
634912-3491278.10282.40
极限138177-3817785.40785.571.0290.7090.791.03
238865-3886586.94692.28
338553-3855386.24891.49
438031-3803185.08090.18
537798-3779884.55989.76
638078-3807885.18590.35
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