左氨氯地平叶酸片项目信息
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5000
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
117.18 1864911864741863111862011865401864030.08
216.951848581852291850440.15
单位质量响应值RSD%判断
10850.0010917.050.44数据可信
供试品溶液-24051101批-左氨氯地平-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1108835-108835101.021100.461.63101.02100.461.63
2108152-108152100.388100.39
3107697-10769799.96599.97
4107811-107811100.071100.07
5105746-10574698.15498.15
6111152-111152103.172103.17
10min1109040-109040101.212101.371.99102.33102.481.98
2107837-107837100.095101.21
3110561-110561102.624103.73
4106518-10651898.87199.98
5108607-108607100.810101.90
6112688-112688104.598105.74
15min1107958-107958100.20799.501.20102.45101.741.19
2106887-10688799.213101.44
3107153-10715399.460101.71
4104859-10485997.33199.54
5108501-108501100.711102.92
6107826-107826100.085102.39
20min1106611-10661198.95799.270.83102.32102.620.83
2106946-10694699.268102.60
3107409-10740999.698103.05
4105369-10536997.804101.10
5107759-107759100.023103.35
6107601-10760199.876103.30
30min1105755-10575598.16398.551.48102.62103.001.46
2105603-10560398.022102.45
3107951-107951100.201104.66
4104242-10424296.758101.14
5105311-10531197.750102.19
6108202-108202100.434104.96
45min1102168-10216894.83395.811.71100.38101.361.65
2101577-10157794.28599.81
3104191-10419196.711102.29
4101422-10142294.14199.59
5105799-10579998.203103.73
6104169-10416996.690102.34
60min1101451-10145194.16896.541.51100.77103.151.45
2103723-10372396.276102.85
3104764-10476497.243103.89
4103155-10315595.749102.25
5105349-10534997.786104.40
6105574-10557497.995104.72
90min1102556-10255695.19394.780.70102.84102.460.72
2101675-10167594.376102.01
3102785-10278595.406103.14
4100924-10092493.678101.24
5102122-10212294.790102.50
6102607-10260795.241103.05
极限1101045-10104593.79193.441.22102.50102.181.20
299558-9955892.410101.10
3102022-10202294.698103.49
498986-9898691.880100.48
5100539-10053993.321102.08
6101865-10186594.552103.42
左氨氯地平叶酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100074-202217 对照品来源中检院对照品使用方法直接使用
对照品含量(%)91.2对照品水分(%)0对照品稀释倍数20000
标示量(mg)0.8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%
116.071969121969221968251968311969381968860.03
216.041979411977651978530.07
单位质量响应值RSD%判断
12251.7712334.980.48数据可信
供试品溶液-24051101批-叶酸-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min117372-1737214.49915.169.7514.5015.169.74
220027-2002716.71516.71
318923-1892315.79315.79
418064-1806415.07615.08
515130-1513012.62812.63
619505-1950516.27916.28
10min136792-3679230.70733.848.3630.8734.018.35
242821-4282135.73935.92
345432-4543237.91838.09
441372-4137234.52934.70
536904-3690430.80030.94
639986-3998633.37333.55
15min148536-4853640.50844.016.5641.0144.556.57
256085-5608546.80947.39
357275-5727547.80248.40
452862-5286244.11944.67
549636-4963641.42641.91
651986-5198643.38843.94
20min154809-5480945.74450.466.6846.7051.496.68
264736-6473654.02955.13
365315-6531554.51255.64
459653-5965349.78750.83
557827-5782748.26349.21
660402-6040250.41251.45
30min162414-6241452.09157.236.4453.5558.826.44
272604-7260460.59662.30
374174-7417461.90663.64
466672-6667255.64557.24
565937-6593755.03156.51
669620-6962058.10559.70
45min167201-6720156.08661.185.8158.1363.415.81
277502-7750264.68467.06
377714-7771464.86167.28
469804-6980458.25960.47
572491-7249160.50162.59
675093-7509362.67364.91
60min170145-7014558.54364.016.4361.2166.926.41
283049-8304969.31372.41
381363-8136367.90671.05
473315-7331561.18964.05
574703-7470362.34865.11
677604-7760464.76967.70
90min174908-7490862.51965.895.6565.8369.515.66
285625-8562571.46375.33
383093-8309369.35073.25
474947-7494762.55166.09
576774-7677464.07667.53
678341-7834165.38469.04
极限187841-8784173.31375.054.6277.3279.414.67
294444-9444478.82383.48
395300-9530079.53884.21
484692-8469270.68474.92
587676-8767673.17577.34
689612-8961274.79179.17
左氨氯地平叶酸片项目信息
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5000
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
117.18 1860841865881865121859911862391862830.15
216.951847421847961847690.03
单位质量响应值RSD%判断
10843.0210900.830.38数据可信
供试品溶液-24051102批-左氨氯地平-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1111879-111879103.958102.941.47103.96102.941.47
2111006-111006103.146103.15
3108185-108185100.525100.53
4112921-112921104.926104.93
5110031-110031102.240102.24
6110693-110693102.856102.86
10min1109429-109429101.681103.050.86102.84104.190.85
2110026-110026102.236103.38
3111663-111663103.757104.87
4111723-111723103.813104.98
5111418-111418103.529104.67
6111141-111141103.272104.41
15min1107055-10705599.475101.181.06101.76103.461.05
2108680-108680100.985103.27
3109139-109139101.412103.68
4110652-110652102.817105.14
5108730-108730101.031103.32
6109053-109053101.332103.62
20min1106283-10628398.758100.791.36102.15104.211.33
2109492-109492101.740105.14
3108465-108465100.785104.18
4109885-109885102.105105.57
5107142-10714299.556102.96
6109579-109579101.820105.24
30min1106550-10655099.00699.791.16103.49104.321.11
2106705-10670599.150103.68
3107200-10720099.610104.13
4107578-10757899.961104.56
5109786-109786102.013106.53
6106532-10653298.989103.54
45min1106519-10651998.97799.000.61104.56104.640.58
2106698-10669899.143104.78
3106862-10686299.296104.92
4107133-10713399.548105.25
5105297-10529797.842103.49
6106732-10673299.175104.82
60min1103841-10384196.48997.680.83103.18104.420.81
2104696-10469697.283104.02
3105503-10550398.033104.76
4106446-10644698.909105.72
5105220-10522097.770104.51
6105011-10501197.576104.33
90min1100205-10020593.11096.281.66100.87104.101.58
2104093-10409396.723104.54
3104359-10435996.970104.79
4104981-10498197.548105.46
5104297-10429796.912104.73
6103740-10374096.395104.23
极限197204-9720490.32294.422.2099.12103.322.06
2101749-10174994.545103.44
3102792-10279295.514104.41
4103108-10310895.808104.80
5102012-10201294.789103.69
6102852-10285295.570104.47
左氨氯地平叶酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100074-202217 对照品来源中检院对照品使用方法直接使用
对照品含量(%)91.2对照品水分(%)0对照品稀释倍数20000
标示量(mg)0.8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%
116.071965491964791970711965811967011966760.12
216.041974631975261974940.03
单位质量响应值RSD%判断
12238.7112312.590.43数据可信
供试品溶液-24051102批-叶酸-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min115800-1580013.20613.537.8813.2113.537.88
217546-1754614.66514.67
314154-1415411.83011.83
416414-1641413.71913.72
515707-1570713.12813.13
617496-1749614.62314.62
10min136021-3602130.10729.714.4530.2529.864.46
236671-3667130.65030.81
332862-3286227.46627.60
435478-3547829.65329.81
534894-3489429.16529.31
637371-3737131.23531.40
15min145685-4568538.18438.703.4338.6739.183.44
247628-4762839.80840.31
343815-4381536.62137.06
446144-4614438.56839.05
546220-4622038.63139.10
648351-4835140.41240.92
20min152035-5203543.49144.524.1844.4045.434.17
255428-5542846.32747.27
350507-5050742.21443.06
452190-5219043.62144.53
553070-5307044.35645.26
656381-5638147.12448.08
30min159916-5991650.07851.003.1251.4752.403.13
262330-6233052.09653.56
359094-5909449.39150.70
459070-5907049.37150.77
562098-6209851.90253.29
663569-6356953.13254.61
45min167617-6761756.51556.422.8458.4658.402.84
268312-6831257.09659.14
366854-6685455.87757.74
464516-6451653.92355.87
567353-6735356.29458.26
670386-7038658.82960.90
60min167485-6748556.40558.854.1658.9861.454.06
270095-7009558.58661.26
370591-7059159.00161.48
466875-6687555.89558.44
573835-7383561.71264.31
673564-7356461.48564.21
90min166508-6650855.58860.745.1058.7963.994.91
273086-7308661.08664.41
375669-7566963.24566.38
470608-7060859.01562.18
573438-7343861.38064.66
676728-7672864.13067.54
极限176900-7690064.27472.286.0668.0976.205.86
287823-8782373.40377.41
388769-8876974.19478.03
484682-8468270.77874.60
588724-8872474.15678.12
691961-9196176.86280.98
左氨氯地平叶酸片项目信息
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5000
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
117.18 1857131858121857251858081859641858040.06
216.951844381846441845410.08
单位质量响应值RSD%判断
10815.1310887.370.48数据可信
供试品溶液-24051103批-左氨氯地平-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1109720-109720102.146101.810.63102.15101.810.63
2110286-110286102.673102.67
3109313-109313101.767101.77
4108336-108336100.858100.86
5108874-108874101.358101.36
6109599-109599102.033102.03
10min1109733-109733102.158101.800.83103.29102.930.82
2110738-110738103.094104.23
3109376-109376101.826102.96
4108033-108033100.575101.70
5109295-109295101.750102.88
6108895-108895101.378102.51
15min1108322-108322100.844100.430.85103.11102.700.84
2108360-108360100.880103.17
3107640-107640100.210102.47
4106401-10640199.056101.29
5109039-109039101.512103.77
6107530-107530100.107102.37
20min1106222-10622298.88999.190.59102.28102.570.59
2107229-10722999.827103.23
3107292-10729299.886103.26
4105991-10599198.674102.01
5106696-10669699.331102.72
6105830-10583098.525101.90
30min1105374-10537498.10097.700.94102.59102.180.92
2106738-10673899.370103.89
3104470-10447097.258101.74
4104258-10425897.061101.50
5104669-10466997.444101.93
6104131-10413196.943101.41
45min1105950-10595098.63697.121.15104.22102.691.11
2104833-10483397.596103.22
3104442-10444297.232102.80
4102817-10281795.719101.23
5103043-10304395.930101.50
6104874-10487497.634103.18
60min1102380-10238095.31395.231.20101.99101.871.15
2103195-10319596.071102.78
3103307-10330796.176102.82
4100346-10034693.419100.00
5101290-10129094.298100.93
6103218-10321896.093102.72
90min1101539-10153994.53094.510.75102.26102.210.72
2101875-10187594.843102.61
3102762-10276295.668103.38
4100965-10096593.995101.61
5101378-10137894.380102.06
6100577-10057793.634101.33
极限1101272-10127294.28194.510.89103.07103.260.86
2102608-10260895.525104.35
3101981-10198194.941103.72
4100006-10000693.103101.76
5101261-10126194.271103.00
6101996-10199694.955103.69
左氨氯地平叶酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100074-202217 对照品来源中检院对照品使用方法直接使用
对照品含量(%)91.2对照品水分(%)0对照品稀释倍数20000
标示量(mg)0.8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%
116.071964571960131964121963121969031964190.17
216.041971431971951971690.02
单位质量响应值RSD%判断
12222.7112292.330.41数据可信
供试品溶液-24051103批-叶酸-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min119570-1957016.38117.067.3016.3817.067.29
221423-2142317.93217.93
322860-2286019.13519.13
420147-2014716.86416.86
518970-1897015.87915.88
619319-1931916.17116.17
10min139778-3977833.29632.946.8633.4833.136.86
240756-4075634.11534.31
343409-4340936.33536.55
439398-3939832.97833.17
536012-3601230.14430.32
636769-3676930.77730.96
15min152119-5211943.62643.737.5744.1844.297.55
253263-5326344.58345.16
359261-5926149.60450.22
451729-5172943.29943.85
548284-4828440.41640.93
648808-4880840.85441.38
20min159853-5985350.10051.129.2151.1452.179.16
261912-6191251.82352.90
371747-7174760.05561.22
459778-5977850.03751.07
556576-5657647.35748.32
656593-5659347.37148.35
30min168595-6859557.41759.6310.5059.0161.2410.43
271993-7199360.26161.91
385852-8585271.86273.70
468654-6865457.46659.06
565709-6570955.00156.49
666620-6662055.76457.27
45min175596-7559663.27766.1512.6665.5168.4212.51
278124-7812465.39367.71
398992-9899282.86185.49
474779-7477962.59364.82
571650-7165059.97462.07
675011-7501162.78764.91
60min176463-7646364.00368.3013.7866.9471.3113.59
281414-8141468.14771.19
3103977-10397787.03390.59
476152-7615263.74366.67
573877-7387761.83864.60
677705-7770565.04267.86
90min179444-7944466.49871.3313.6470.1475.1013.47
284949-8494971.10674.91
3108454-10845490.78195.30
480483-8048367.36871.00
577939-7793965.23868.69
680053-8005367.00870.55
极限192873-9287377.73981.808.7782.1286.368.87
2100407-10040784.04588.64
3113778-11377895.237100.77
493347-9334778.13682.52
590298-9029875.58379.76
695622-9562280.04084.33
左氨氯地平叶酸片项目信息
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5000
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
117.18 1856951856661856671855671858171856820.05
216.951847011848711847860.07
单位质量响应值RSD%判断
10808.0310901.830.62数据可信
供试品溶液-24051301批-左氨氯地平-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1113943-113943106.042105.201.71106.04105.201.71
2112920-112920105.090105.09
3116077-116077108.028108.03
4113134-113134105.289105.29
5110454-110454102.795102.80
6111718-111718103.972103.97
10min1109756-109756102.146104.622.23103.32105.792.20
2112463-112463104.665105.83
3114917-114917106.949108.15
4109421-109421101.834103.00
5115393-115393107.392108.53
6112543-112543104.739105.89
15min1107283-10728399.844102.512.46102.16104.842.43
2111259-111259103.544105.88
3112747-112747104.929107.32
4107491-107491100.038102.34
5113463-113463105.596107.93
6108613-108613101.082103.40
20min1111678-111678103.934103.022.86107.36106.492.81
2110937-110937103.245106.73
3112851-112851105.026108.58
4105076-10507697.790101.20
5114076-114076106.166109.67
6109547-109547101.951105.39
30min1102201-10220195.115100.143.4499.69104.753.35
2107603-107603100.142104.77
3111928-111928104.167108.89
4104937-10493797.661102.16
5111244-111244103.530108.22
6107662-107662100.197104.77
45min1102152-10215295.06999.022.99100.70104.742.93
2105316-10531698.014103.75
3110435-110435102.778108.66
4104150-10415096.928102.51
5109505-109505101.912107.75
6106794-10679499.389105.08
60min1102256-10225695.16698.872.74101.86105.702.69
2105608-10560898.285105.12
3108631-108631101.099108.12
4104351-10435197.115103.78
5110325-110325102.675109.65
6106272-10627298.903105.70
90min199085-9908592.21597.173.5599.96105.103.43
2103221-10322196.064103.99
3107142-10714299.713107.86
4101773-10177394.716102.46
5109020-109020101.461109.57
6106212-10621298.847106.74
极限1101435-10143594.40294.580.96103.17103.590.97
2102718-10271895.596104.59
3102124-10212495.043104.29
499997-9999793.063101.86
5101226-10122694.207103.45
6102287-10228795.195104.18
左氨氯地平叶酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100074-202217 对照品来源中检院对照品使用方法直接使用
对照品含量(%)91.2对照品水分(%)0对照品稀释倍数20000
标示量(mg)0.8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%
116.071961471960241962541960181960581961000.06
216.041973501972601973050.04
单位质量响应值RSD%判断
12202.8612300.810.57数据可信
供试品溶液-24051301批-叶酸-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min126734-2673422.38821.833.6822.3921.833.68
227311-2731122.87122.87
326290-2629022.01622.02
425968-2596821.74721.75
525562-2556221.40721.41
624552-2455220.56120.56
10min148012-4801240.20739.603.0740.4639.843.06
248777-4877740.84841.10
346967-4696739.33239.58
446952-4695239.31939.56
544731-4473137.45937.70
648287-4828740.43740.67
15min158901-5890149.32651.053.7950.0251.733.77
265070-6507054.49255.20
361167-6116751.22451.91
461157-6115751.21551.89
558629-5862949.09849.75
660817-6081750.93151.61
20min172619-7261960.81459.883.6762.0661.133.65
275713-7571363.40564.72
371861-7186160.17961.43
468404-6840457.28458.53
569136-6913657.89759.10
671289-7128959.70060.94
30min175182-7518262.96068.285.1464.8870.205.05
286747-8674772.64574.66
384012-8401270.35572.27
481141-8114167.95169.83
578475-7847565.71867.56
683661-8366170.06171.97
45min181160-8116067.96774.485.2870.5977.165.18
294214-9421478.89881.72
390671-9067175.93178.63
489298-8929874.78277.42
586113-8611372.11474.69
692207-9220777.21879.90
60min185034-8503471.21177.525.1274.5881.025.05
297923-9792382.00585.71
395134-9513479.66983.21
492503-9250377.46680.94
589236-8923674.73078.10
695588-9558880.04983.59
90min186806-8680672.69578.924.9276.8683.284.85
299060-9906082.95787.57
396801-9680181.06585.49
492814-9281477.72682.06
591856-9185676.92481.13
698075-9807582.13286.56
极限193055-9305577.92881.958.8082.9087.198.41
2100670-10067084.30589.84
3113941-11394195.419100.75
493268-9326878.10683.30
590418-9041875.72080.78
695777-9577780.20785.55
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