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1.000
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.994189041973419794198641962419580.10
29.984192341979419510.10
单位质量响应值RSD%判断
4200.004203.510.06数据可信
供试品溶液-24050601批-培哚普利-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min135812-3581272.71969.303.0872.7269.303.08
232839-3283966.68266.68
334628-3462870.31570.31
433299-3329967.61667.62
534301-3430169.65169.65
633897-3389768.83168.83
10min136180-3618073.46673.923.4674.2774.693.42
237875-3787576.90877.65
338070-3807077.30478.09
435598-3559872.28573.04
535370-3537071.82272.60
635315-3531571.71072.47
15min135864-3586472.82574.673.9074.4576.263.85
238166-3816677.49979.09
338912-3891279.01480.65
435752-3575272.59774.15
536505-3650574.12675.70
635425-3542571.93373.49
20min136094-3609473.29274.333.1275.7376.753.08
238150-3815077.46779.92
337772-3777276.69979.22
436596-3659674.31176.67
535299-3529971.67774.07
635728-3572872.54974.91
30min135997-3599773.09574.532.8876.3477.782.84
238002-3800277.16680.48
337842-3784276.84180.21
436636-3663674.39277.58
535286-3528671.65174.84
636461-3646174.03777.20
45min137217-3721775.57276.092.8679.6380.172.82
239173-3917379.54483.72
338198-3819877.56481.79
437374-3737475.89179.90
536216-3621673.54077.53
636663-3666374.44778.44
极限140459-4045982.15580.791.4087.0585.711.28
240016-4001681.25686.31
338870-3887078.92984.01
439972-3997281.16686.02
539426-3942680.05884.86
639978-3997881.17986.00
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4000
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%
113.757758877874778637783277864778040.16
213.897769477660776770.04
单位质量响应值RSD%判断
5658.475592.300.84数据可信
供试品溶液-24050601批-左氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min144396-44396102.325100.613.11102.32100.613.11
245087-45087103.917103.92
343795-43795100.939100.94
444448-44448102.444102.44
541362-4136295.33295.33
642820-4282098.69298.69
10min145558-45558105.003101.672.06106.14102.782.06
244481-44481102.520103.68
343523-43523100.312101.43
444501-44501102.567103.70
543124-4312499.393100.45
643474-43474100.200101.30
15min143952-43952101.30199.861.43103.60102.101.45
243777-43777100.898103.19
343607-43607100.506102.74
443485-43485100.225102.50
542406-4240697.73899.90
642722-4272298.466100.68
20min143839-43839101.04198.851.86104.47102.211.87
243451-43451100.147103.56
342538-4253898.042101.40
443411-43411100.054103.45
541781-4178196.29799.55
642311-4231197.519100.82
30min142047-4204796.91195.811.46101.46100.271.48
242020-4202096.848101.38
341893-4189396.556101.00
441652-4165296.000100.50
540450-4045093.23097.55
641364-4136495.33699.72
45min142513-4251397.98595.022.68103.61100.542.63
242532-4253298.028103.63
340924-4092494.32299.84
441223-4122395.011100.58
540100-4010092.42397.78
640063-4006392.33897.78
极限141756-4175696.24095.811.15102.96102.381.17
242355-4235597.620104.31
341255-4125595.085101.65
441373-4137395.357101.98
540990-4099094.474100.86
641682-4168296.069102.54
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1.000
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.994180341810418534185241846418330.06
29.984197741997419870.04
单位质量响应值RSD%判断
4187.494207.110.34数据可信
供试品溶液-24050601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%
5min139788-3978880.87977.824.3980.8877.824.39
238495-3849578.25178.25
340380-4038082.08282.08
437664-3766476.56176.56
537650-3765076.53376.53
635720-3572072.61072.61
10min140969-4096983.28081.203.9284.1882.063.92
239939-3993981.18682.06
340914-4091483.16884.08
440408-4040882.13982.99
540593-4059382.51583.37
636843-3684374.89275.70
15min141073-4107383.49180.434.0185.3182.204.00
239370-3937080.02981.80
340027-4002781.36583.20
439878-3987881.06282.83
540502-4050282.33084.10
636555-3655574.30775.95
20min140446-4044682.21679.583.8784.9782.243.87
239112-3911279.50582.17
339783-3978380.86983.61
439211-3921179.70682.37
540092-4009281.49784.18
636235-3623573.65776.12
30min140123-4012381.56079.193.6785.2382.743.67
238962-3896279.20082.74
339945-3994581.19884.84
438367-3836777.99081.54
539947-3994781.20284.79
636405-3640574.00277.29
45min139618-3961880.53379.113.3185.1083.533.32
239203-3920379.69084.11
339132-3913279.54584.09
438606-3860678.47682.89
540363-4036382.04886.54
636580-3658074.35878.46
极限140679-4067982.69081.292.6088.1686.592.58
239623-3962380.54385.85
339706-3970680.71286.14
439042-3904279.36284.65
541746-4174684.85990.26
639137-3913779.55684.49
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4000
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%
113.757752977581776007763977633775960.06
213.897775777756777560.01
单位质量响应值RSD%判断
5643.355597.980.58数据可信
供试品溶液-24050601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%
5min134645-3464579.91680.901.7379.9280.901.73
235945-3594582.91582.91
335079-3507980.91780.92
434203-3420378.89678.90
535441-3544181.75281.75
635123-3512381.01981.02
10min139092-3909290.17490.660.9291.0691.560.91
239008-3900889.98090.90
338899-3889989.72990.63
439434-3943490.96391.84
539834-3983491.88592.79
639541-3954191.21092.11
15min138934-3893489.80991.671.9791.7093.581.93
239501-3950191.11793.04
339130-3913090.26192.16
441016-4101694.61296.50
540291-4029192.94094.87
639571-3957191.27993.19
20min139053-3905390.08491.421.7792.9794.341.73
239225-3922590.48193.41
339256-3925690.55293.45
440910-4091094.36797.31
539957-3995792.16995.13
639396-3939690.87593.80
30min138866-3886689.65390.951.3393.5494.891.31
239411-3941190.91094.85
339363-3936390.79994.70
440417-4041793.23097.22
539357-3935790.78594.77
639160-3916090.33194.27
45min138636-3863689.12291.232.3294.0196.182.25
240344-4034493.06298.01
338628-3862889.10494.02
440760-4076094.02199.04
539912-3991292.06597.06
639017-3901790.00194.94
极限138490-3849088.78590.771.9594.6696.741.90
239157-3915790.32496.31
338612-3861289.06794.97
440544-4054493.52399.59
539594-3959491.33297.35
639714-3971491.60997.55
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1.000
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.994216942449423714248142521423980.33
29.984212742034420800.16
单位质量响应值RSD%判断
4244.044216.430.47数据可信
供试品溶液-24050601批-培哚普利-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min139544-3954479.75783.742.8979.7683.742.90
242171-4217185.05685.06
342030-4203084.77284.77
442658-4265886.03886.04
540564-4056481.81581.81
642151-4215185.01685.02
10min142254-4225485.22383.801.9686.1184.731.94
241741-4174184.18985.13
341916-4191684.54285.48
442203-4220385.12086.08
540175-4017581.03081.94
640991-4099182.67683.62
15min141866-4186684.44182.971.6886.2784.831.66
241609-4160983.92285.80
341370-4137083.44085.32
441356-4135683.41285.31
540043-4004380.76482.57
640572-4057281.83183.69
20min140753-4075382.19681.491.9984.9784.281.94
241321-4132183.34286.15
341087-4108782.87085.68
439273-3927379.21182.04
539701-3970180.07482.78
640288-4028881.25884.03
30min137420-3742075.47377.962.5979.1681.652.50
240338-4033881.35985.10
338163-3816376.97280.70
439024-3902478.70982.42
538815-3881578.28781.88
638159-3815976.96480.64
45min139929-3992980.53480.122.0285.0684.681.95
240710-4071082.10986.75
338966-3896678.59283.18
440496-4049681.67886.26
539505-3950579.67984.15
638736-3873678.12882.66
极限140062-4006280.80278.593.1386.2284.032.95
239682-3968280.03685.59
337518-3751875.67181.13
440054-4005480.78686.28
539046-3904678.75384.10
637417-3741775.46780.87
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4000
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%
113.757803078270781417815878149781500.11
213.897791077903779060.01
单位质量响应值RSD%判断
5683.645608.780.94数据可信
供试品溶液-24050601批-左氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min139191-3919189.99696.433.5890.0096.423.58
241770-4177095.91895.92
342151-4215196.79396.79
442441-4244197.45997.46
542853-4285398.40598.40
643541-4354199.98599.98
10min141817-4181796.02697.501.4097.0398.581.41
242435-4243597.44598.51
342216-4221696.94298.02
442009-4200996.46797.55
542879-4287998.46599.56
643405-4340599.672100.78
15min141735-4173595.83896.661.8297.9098.821.82
241875-4187596.15998.31
341744-4174495.85898.01
441389-4138995.04397.20
542276-4227697.08099.27
643544-4354499.992102.21
20min140290-4029092.51996.012.3895.6599.242.36
241573-4157395.46698.68
341272-4127294.77497.99
442096-4209696.66799.88
542512-4251297.622100.89
643106-4310698.986102.32
30min137081-3708185.15089.914.2189.3194.214.09
240493-4049392.98697.26
337693-3769386.55690.83
438381-3838188.13692.42
541032-4103294.22398.57
640250-4025092.42896.86
45min139763-3976391.30993.181.4496.4298.481.47
241211-4121194.63499.95
340244-4024492.41497.65
440276-4027692.48797.75
540783-4078393.65199.05
641199-4119994.607100.06
极限139867-3986791.54891.392.1897.6797.722.10
240210-4021092.33698.70
338073-3807387.42893.69
440038-4003891.94198.23
540222-4022292.36398.80
640387-4038792.74299.25
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1.000
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.994177141779418414180941789417980.07
29.984193441935419340.01
单位质量响应值RSD%判断
4183.984201.800.31数据可信
供试品溶液-24050601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%
5min139594-3959480.56982.051.2180.5782.061.21
240742-4074282.90582.91
340909-4090983.24583.24
440469-4046982.35082.35
540213-4021381.82981.83
640017-4001781.43081.43
10min137812-3781276.94381.222.7077.8482.142.69
240686-4068682.79183.71
340412-4041282.23483.16
440614-4061482.64583.56
540134-4013481.66882.58
639836-3983681.06281.97
15min138597-3859778.54080.471.5980.2982.291.58
240303-4030382.01283.85
339004-3900479.36881.21
439862-3986281.11482.95
539805-3980580.99882.82
639709-3970980.80382.61
20min138249-3824977.83278.680.7380.4581.390.75
238597-3859778.54081.29
338872-3887279.10081.82
438875-3887579.10681.84
538955-3895579.26981.99
638447-3844778.23580.94
30min139781-3978180.95080.130.6584.4483.720.60
239575-3957580.53084.16
339334-3933480.04083.64
439317-3931780.00583.62
539158-3915879.68283.28
639111-3911179.58683.16
45min137578-3757876.46778.101.4580.8582.571.40
237866-3786677.05381.57
338475-3847578.29282.78
439062-3906279.48783.99
538691-3869178.73283.21
638605-3860578.55783.01
极限135901-3590173.05476.442.4178.2981.782.31
238588-3858878.52283.90
337554-3755476.41881.78
437553-3755376.41681.80
537755-3775576.82782.18
638047-3804777.42182.75
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4000
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%
113.757752877542776007758777586775690.05
213.897738477451774180.07
单位质量响应值RSD%判断
5641.385573.650.86数据可信
供试品溶液-24050601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%
5min133593-3359377.67380.122.3777.6780.122.37
235343-3534381.71981.72
335262-3526281.53281.53
434246-3424679.18279.18
535515-3551582.11682.12
633957-3395778.51478.51
10min136259-3625983.83789.483.4784.7090.373.45
239779-3977991.97692.88
338835-3883589.79390.70
439610-3961091.58592.46
539552-3955291.45192.36
638157-3815788.22589.10
15min137680-3768087.12289.672.5388.9291.552.51
239393-3939391.08393.01
337590-3759086.91488.82
439359-3935991.00492.90
539985-3998592.45294.38
638681-3868189.43791.29
20min137721-3772187.21789.231.5089.9892.111.49
238224-3822488.38091.32
338396-3839688.77891.65
438918-3891889.98592.89
539147-3914790.51493.47
639147-3914790.51493.36
30min139916-3991692.29291.731.1796.0295.601.15
239648-3964891.67395.60
339375-3937591.04194.90
439537-3953791.41695.32
540443-4044393.51197.47
639114-3911490.43894.29
45min137859-3785987.53689.911.9592.2994.801.94
239111-3911190.43195.37
338705-3870589.49294.36
439282-3928290.82695.75
540015-4001592.52197.52
638336-3833688.63993.50
极限137075-3707585.72389.972.7991.4595.862.71
240202-4020292.95498.90
339159-3915990.54296.40
438805-3880589.72495.66
539696-3969691.78497.81
638528-3852889.08394.92
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