培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号101072-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)2供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.411669651653211663251655311652801658840.45
216.471643051642911642980.01
单位质量响应值RSD%判断
10108.719975.590.94数据可信
长期6月-供试品溶液-2023110721批-培哚普-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%
5min155532-5553234.49431.9610.2434.4931.9610.24
245531-4553128.28228.28
352909-5290932.86532.86
459108-5910836.71536.72
547959-4795929.79029.79
647697-4769729.62729.63
10min1142970-14297088.80789.312.6088.9589.442.59
2140733-14073387.41887.53
3143250-14325088.98189.11
4141483-14148387.88388.03
5143157-14315788.92389.04
6151097-15109793.85593.97
15min1164545-164545102.209101.721.07102.70102.211.06
2164891-164891102.424102.89
3165430-165430102.758103.25
4160864-16086499.922100.42
5162469-162469100.919101.39
6164368-164368102.099102.59
20min1165593-165593102.860101.531.80103.76102.421.78
2164287-164287102.048102.92
3166603-166603103.487104.39
4162796-162796101.122102.02
5163156-163156101.346102.22
6158245-15824598.29599.20
30min1166548-166548103.453100.732.06104.77102.022.04
2163910-163910101.814103.09
3161453-161453100.288101.60
4164229-164229102.012103.31
5157984-15798498.13399.42
6158818-15881898.65199.95
45min1159350-15935098.98298.860.91100.71100.560.91
2159652-15965299.169100.86
3161281-161281100.181101.89
4159573-15957399.120100.83
5157655-15765597.92999.61
6157371-15737197.75299.44
60min1165577-165577102.85099.722.51104.97101.822.47
2158648-15864898.546100.63
3165706-165706102.930105.04
4158993-15899398.760100.87
5157143-15714397.61199.68
6157211-15721197.65399.73
极限1160128-16012899.46598.320.98102.00100.820.98
2157894-15789498.077100.56
3160024-16002499.400101.93
4158335-15833598.351100.85
5156445-15644597.17799.64
6156910-15691097.46699.94
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号100275-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.2对照品水分(%)0对照品稀释倍数10000
标示量(mg)0.625供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.303075743064993067333067283064923068050.15
212.353064313062873063590.04
单位质量响应值RSD%判断
24943.5024806.400.39数据可信
长期6月-供试品溶液-2023110721批-利吲达帕胺-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%
5min139079-3907912.34211.409.1112.3411.409.12
230883-308839.7549.75
335899-3589911.33811.34
440046-4004612.64712.65
536054-3605411.38711.39
634590-3459010.92410.92
10min1124566-12456639.34137.805.6339.3937.855.63
2108603-10860334.29934.34
3117009-11700936.95437.00
4128191-12819140.48640.54
5120192-12019237.95938.00
6119583-11958337.76737.81
15min1182476-18247657.63057.181.3957.8457.381.38
2178326-17832656.31956.50
3179044-17904456.54656.74
4180142-18014256.89357.11
5181221-18122157.23457.43
6185164-18516458.47958.67
20min1214413-21441367.71667.601.6868.1568.021.66
2214150-21415067.63368.03
3212732-21273267.18567.60
4209554-20955466.18266.62
5212951-21295167.25567.68
6220423-22042369.61470.04
30min1249197-24919778.70278.471.6479.4179.171.62
2249971-24997178.94679.62
3246504-24650477.85178.54
4242746-24274676.66577.37
5247466-24746678.15578.85
6254933-25493380.51381.22
45min1270264-27026485.35585.771.6986.3886.781.68
2275096-27509686.88187.87
3270958-27095885.57586.57
4265257-26525783.77484.79
5269473-26947385.10686.11
6278388-27838887.92188.95
60min1283660-28366089.58689.441.5790.9590.801.55
2285921-28592190.30091.64
3282967-28296789.36790.71
4276955-27695587.46988.82
5280092-28009288.45989.81
6289668-28966891.48492.86
极限1295595-29559593.35592.611.4195.0894.321.40
2295332-29533293.27294.97
3293078-29307892.56194.26
4289042-28904291.28692.98
5287844-28784490.90892.61
6298529-29852994.28296.03
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号101072-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)2供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.411653951654311650771652921650691652530.11
216.471638711638741638720.01
单位质量响应值RSD%判断
10070.269949.730.86数据可信
长期6月-供试品溶液-2023110821批-培哚普
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min163018-6301839.27050.7544.7539.2750.7544.75
2152683-15268395.14495.14
370702-7070244.05844.06
484941-8494152.93152.93
553120-5312033.10233.10
664223-6422340.02140.02
10min1139830-13983087.13596.505.5487.2996.705.56
2160007-16000799.708100.09
3162199-162199101.074101.25
4157727-15772798.28898.50
5159812-15981299.58799.72
6149579-14957993.21093.37
15min1152074-15207494.76599.062.2495.2799.652.26
2159300-15930099.268100.05
3162499-162499101.261101.84
4159934-15993499.663100.27
5160197-16019799.827100.36
6159794-15979499.576100.11
20min1156041-15604197.23799.611.3598.12100.591.36
2159297-15929799.266100.44
3162541-162541101.287102.27
4160621-160621100.091101.09
5160060-16006099.741100.67
6160492-160492100.011100.94
30min1157932-15793298.41599.340.9199.69100.730.91
2159019-15901999.093100.67
3161803-161803100.828102.22
4158027-15802798.47499.88
5159720-15972099.529100.86
6160034-16003499.725101.06
45min1157762-15776298.30999.350.8599.98101.130.85
2158387-15838798.699100.67
3161693-161693100.759102.55
4159825-15982599.595101.39
5159362-15936299.306101.03
6159547-15954799.422101.15
60min1157395-15739598.08199.090.82100.14101.270.82
2158052-15805298.490100.85
3160910-160910100.271102.47
4160087-16008799.758101.95
5158808-15880898.961101.09
6158832-15883298.976101.10
极限1157137-15713797.92098.720.73100.37101.300.72
2157566-15756698.187100.95
3160444-16044499.981102.58
4158620-15862098.844101.44
5158377-15837798.693101.21
6158409-15840998.713101.24
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号100275-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.2对照品水分(%)0对照品稀释倍数10000
标示量(mg)0.625供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.303072923070893071473069363070643071060.05
212.353056213053193054700.07
单位质量响应值RSD%判断
24967.9724734.410.67数据可信
长期6月-供试品溶液-2023110821批-利吲达帕胺
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min145294-4529414.31916.8030.8514.3216.8030.86
284867-8486726.82926.83
350473-5047315.95615.96
452995-5299516.75316.75
537836-3783611.96111.96
647335-4733514.96414.96
10min1127695-12769540.36844.8810.1040.4344.9510.12
2165903-16590352.44752.55
3145858-14585846.11046.17
4148119-14811946.82546.89
5133684-13368442.26142.31
6130633-13063341.29741.36
15min1173789-17378954.94059.705.5955.1659.955.63
2203981-20398164.48464.80
3195370-19537061.76262.01
4191996-19199660.69560.95
5185040-18504058.49658.71
6182985-18298557.84758.07
20min1203111-20311164.20968.394.0564.6568.884.08
2227824-22782472.02272.60
3222555-22255570.35670.85
4219289-21928969.32469.82
5213010-21301067.33967.79
6212226-21222667.09167.55
30min1238420-23842075.37178.292.5976.0779.052.63
2255277-25527780.70081.56
3254512-25451280.45981.24
4247567-24756778.26379.04
5246007-24600777.77078.49
6244189-24418977.19577.92
45min1266511-26651184.25286.161.8085.2587.231.84
2276934-27693487.54788.73
3278473-27847388.03389.13
4274419-27441986.75287.84
5271179-27117985.72786.76
6267702-26770284.62885.66
60min1279621-27962188.39689.781.4689.7391.201.51
2287659-28765990.93792.47
3288822-28882291.30592.76
4286169-28616990.46691.90
5282642-28264289.35190.73
6279143-27914388.24589.62
极限1293423-29342392.75993.110.9994.4594.891.03
2297042-29704293.90395.80
3297335-29733593.99695.81
4296384-29638493.69595.49
5293184-29318492.68494.42
6289883-28988391.64093.37
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号101072-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)2供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.411633781634551635111635611635231634860.05
216.471644691644091644390.03
单位质量响应值RSD%判断
9962.589984.150.16数据可信
长期6月-供试品溶液-2023110822批-培哚普
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min149417-4941730.90643.5344.3830.9143.5344.39
2130563-13056381.65681.66
365788-6578841.14541.14
465660-6566041.06541.06
559131-5913136.98136.98
647073-4707329.44029.44
10min1157326-15732698.39496.743.4998.5296.923.49
2157461-15746198.47998.81
3151645-15164594.84195.01
4145816-14581691.19691.36
5161212-161212100.825100.97
6154661-15466196.72896.85
15min1159476-15947699.73999.172.19100.2699.732.17
2157743-15774398.65599.38
3157018-15701898.20298.75
4153153-15315395.78496.31
5163258-163258102.104102.66
6160738-160738100.528101.03
20min1158800-15880099.31699.061.91100.23100.021.90
2157541-15754198.52999.64
3156754-15675498.03798.97
4153986-15398696.30597.22
5162512-162512101.638102.60
6160796-160796100.564101.47
30min1158795-15879599.31398.951.86100.63100.301.83
2156652-15665297.97399.48
3156926-15692698.14499.47
4154149-15414996.40797.70
5162350-162350101.536102.90
6160414-160414100.326101.63
45min1158576-15857699.17698.721.83100.89100.471.80
2156517-15651797.88899.79
3156383-15638397.80499.53
4153894-15389496.24897.93
5162122-162122101.394103.17
6159568-15956899.796101.51
60min1158252-15825298.97399.101.88101.08101.241.89
2160399-160399100.316102.61
3155888-15588897.49599.61
4154149-15414996.40798.48
5162034-162034101.339103.52
6159981-159981100.055102.16
极限1157880-15788098.74198.331.66101.24100.871.63
2155733-15573397.398100.09
3155722-15572297.39199.89
4153839-15383996.21398.67
5160803-160803100.569103.15
6159344-15934499.656102.17
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号100275-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.2对照品水分(%)0对照品稀释倍数10000
标示量(mg)0.625供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.303049593048843048543052303049003049650.06
212.353059343058833059080.02
单位质量响应值RSD%判断
24793.9024769.880.07数据可信
长期6月-供试品溶液-2023110822批-利吲达帕胺
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min134642-3464210.98214.7632.7110.9814.7632.70
276152-7615224.14124.14
343769-4376913.87513.88
446965-4696514.88814.89
541918-4191813.28813.29
635962-3596211.40011.40
10min1129488-12948841.04843.798.0241.0943.858.05
2159887-15988750.68550.78
3136456-13645643.25743.31
4134892-13489242.76242.82
5137124-13712443.46943.52
6131052-13105241.54441.59
15min1180825-18082557.32359.783.9557.5360.013.98
2201682-20168263.93464.23
3190155-19015560.28060.51
4182643-18264357.89958.13
5189779-18977960.16160.39
6186313-18631359.06259.27
20min1210107-21010766.60568.942.5967.0469.422.62
2225667-22566771.53872.09
3219847-21984769.69370.16
4212100-21210067.23767.70
5218838-21883869.37369.84
6218366-21836669.22369.67
30min1240497-24049776.23978.852.2676.9479.602.27
2252808-25280880.14280.98
3252556-25255680.06280.81
4242926-24292677.00977.74
5250280-25028079.34080.09
6253402-25340280.33081.05
45min1262001-26200183.05685.862.2084.0686.932.20
2272052-27205286.24287.40
3275710-27571087.40288.47
4265747-26574784.24385.28
5271968-27196886.21587.28
6277667-27766788.02289.07
60min1271823-27182386.16989.142.2787.5190.542.26
2281265-28126589.16390.67
3286418-28641890.79692.21
4277074-27707487.83489.21
5280923-28092389.05490.46
6289610-28961091.80893.21
极限1282834-28283489.66092.172.3891.3593.942.37
2291223-29122392.31994.18
3297398-29739894.27796.06
4285792-28579290.59892.33
5286919-28691990.95592.72
6300348-30034895.21296.98
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