达格列净二甲双胍缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号101568-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)80.4对照品水分(%)0对照品稀释倍数1250
标示量(mg)10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%
112.691642041638431642641642551645171642170.15
212.681659781651961655870.34
单位质量响应值RSD%判断
12940.6613058.910.65数据可信
供试品溶液-2025070821批-达格列净-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%
5min1184055-18405591.06890.452.3091.0790.452.30
2179454-17945488.79288.79
3179156-17915688.64488.64
4186871-18687192.46192.46
5188362-18836293.19993.20
6178988-17898888.56188.56
10min1189456-18945693.74092.831.1393.8892.971.13
2186973-18697392.51292.65
3184054-18405491.06891.20
4188318-18831893.17793.32
5189812-18981293.91794.06
6187067-18706792.55892.69
15min1189983-18998394.00193.772.2694.2894.042.26
2188241-18824193.13993.41
3184312-18431291.19591.46
4197322-19732297.63297.91
5188898-18889893.46493.75
6188307-18830793.17293.44
20min1191257-19125794.63293.521.2095.0593.941.19
2189845-18984593.93394.34
3184969-18496991.52091.93
4190273-19027394.14594.57
5189776-18977693.89994.32
6187981-18798193.01193.42
30min1190309-19030994.16393.611.1094.7294.171.09
2190589-19058994.30194.85
3185095-18509591.58392.13
4190229-19022994.12394.69
5189704-18970493.86394.42
6189245-18924593.63694.19
45min1188999-18899993.51493.321.1994.2294.021.19
2190966-19096694.48895.18
3184547-18454791.31291.99
4188334-18833493.18593.89
5188505-18850593.27093.97
6190296-19029694.15694.85
60min1190238-19023894.12793.331.2594.9794.171.25
2189381-18938193.70394.54
3184558-18455891.31792.13
4190357-19035794.18695.03
5187072-18707292.56193.40
6190198-19019894.10894.94
120min1190147-19014794.08293.561.2595.0794.541.24
2191838-19183894.91995.90
3184911-18491191.49292.45
4190020-19002094.02095.01
5189279-18927993.65394.63
6188389-18838993.21394.19
180min1190245-19024594.13193.821.6795.2594.941.66
2192468-19246895.23196.35
3183724-18372490.90492.00
4191365-19136594.68595.81
5188709-18870993.37194.49
6191186-19118694.59695.71
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1189164-18916493.59693.791.2894.8695.041.28
2193145-19314595.56696.83
3186008-18600892.03493.26
4191014-19101494.51195.78
5188303-18830393.17094.43
6189679-18967993.85195.11
360min1189100-18910093.56493.651.1894.9795.051.18
2192007-19200795.00396.41
3185311-18531191.69093.06
4190228-19022894.12295.54
5188882-18888293.45694.86
6190094-19009494.05695.45
480min1192179-19217995.08894.701.3696.6396.241.35
2194284-19428496.12997.68
3187179-18717992.61494.12
4193324-19332495.65497.21
5191659-19165994.83096.37
6189700-18970093.86195.40
600min1190463-19046394.23994.491.3795.9396.171.36
2194404-19440496.18997.88
3186448-18644892.25293.90
4192071-19207195.03496.73
5191241-19124194.62496.31
6191212-19121294.60996.29
720min1189861-18986193.94194.111.4295.7795.931.42
2193393-19339395.68897.52
3185389-18538991.72893.51
4190902-19090294.45696.30
5189938-18993893.97995.80
6191757-19175794.87996.70
极限1190544-19054494.27993.901.3096.2595.871.30
2192612-19261295.30297.28
3185415-18541591.74193.66
4189667-18966793.84595.83
5189170-18917093.59995.57
6191289-19128994.64796.61
达格列净二甲双胍缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100664-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数10
标示量(mg)1000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%
110.139485739487339474849519029508479495080.20
210.139597739575989586860.17
单位质量响应值RSD%判断
93732.2894638.300.69数据可信
供试品溶液-2025070821批-二甲双胍-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%
5min155448-554485.8875.4810.515.895.4810.51
245111-451114.7904.79
352302-523025.5535.55
448464-484645.1465.15
559898-598986.3606.36
648324-483245.1315.13
10min1103454-10345410.98410.492.9910.9910.502.98
294369-9436910.02010.03
398350-9835010.44210.45
497696-9769610.37310.38
599528-9952810.56710.58
699434-9943410.55810.57
15min1143921-14392115.28114.884.3515.3114.904.34
2131535-13153513.96613.99
3136108-13610814.45114.48
4148794-14879415.79815.82
5138430-13843014.69814.72
6141890-14189015.06515.09
20min1182795-18279519.40818.343.4119.4618.393.43
2164358-16435817.45117.49
3171981-17198118.26018.31
4173326-17332618.40318.45
5172390-17239018.30418.35
6171651-17165118.22518.27
30min1230655-23065524.49023.861.9624.5723.931.96
2218724-21872423.22323.29
3220638-22063823.42623.50
4224965-22496523.88623.96
5226169-22616924.01424.09
6227169-22716924.12024.19
45min1293615-29361531.17530.461.8131.2930.571.82
2280291-28029129.76029.86
3282214-28221429.96430.07
4285214-28521430.28330.39
5289974-28997430.78830.90
6290231-29023130.81630.93
60min1351033-35103337.27136.092.3137.4336.252.31
2328525-32852534.88235.03
3337013-33701335.78335.94
4341850-34185036.29636.45
5336080-33608035.68435.84
6345027-34502736.63436.79
120min1500389-50038953.12952.331.3853.3552.541.39
2482305-48230551.20951.41
3487026-48702651.71151.92
4495680-49568052.62952.84
5494626-49462652.51752.73
6496930-49693052.76252.97
180min1610436-61043664.81464.271.1165.1164.561.11
2597265-59726563.41563.69
3597932-59793263.48663.77
4610416-61041664.81265.10
5603788-60378864.10864.40
6612272-61227265.00965.30
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1697088-69708874.01473.150.9274.4173.540.93
2684806-68480672.71073.08
3682301-68230172.44472.82
4694274-69427473.71574.10
5683129-68312972.53272.92
6692196-69219673.49573.88
360min1824834-82483487.57886.241.2488.0886.731.24
2800284-80028484.97185.45
3805486-80548685.52386.01
4812945-81294586.31586.81
5806496-80649685.63186.12
6823312-82331287.41687.91
480min1915548-91554897.20995.511.0497.8596.141.05
2890876-89087694.59095.20
3893262-89326294.84395.46
4899207-89920795.47496.10
5893546-89354694.87395.50
6905077-90507796.09896.73
600min1950036-950036100.87199.810.72101.65100.570.72
2932523-93252399.01299.76
3934730-93473099.246100.00
4942552-942552100.077100.85
5936056-93605699.387100.15
6944289-944289100.261101.03
720min1971414-971414103.141102.011.05104.07102.921.05
2947488-947488100.601101.50
3956251-956251101.531102.44
4958938-958938101.816102.74
5956456-956456101.553102.47
6973848-973848103.399104.32
极限1973761-973761103.390101.811.02104.48102.881.02
2950633-950633100.935101.99
3957443-957443101.658102.72
4953823-953823101.273102.35
5949987-949987100.866101.93
6967839-967839102.761103.84
达格列净二甲双胍缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号101568-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)80.4对照品水分(%)0对照品稀释倍数1250
标示量(mg)10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%
112.691666471663041667541662231659011663660.21
212.681682831668221675520.62
单位质量响应值RSD%判断
13110.0113213.880.56数据可信
供试品溶液-2025070821批-达格列净-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%
5min1181744-18174488.81686.974.0288.8286.974.02
2184990-18499090.40390.40
3179836-17983687.88487.88
4170561-17056183.35183.35
5183075-18307589.46789.47
6167587-16758781.89881.90
10min1187717-18771791.73589.933.4291.8790.063.42
2190034-19003492.86893.00
3187206-18720691.48691.62
4177377-17737786.68286.81
5186960-18696091.36591.50
6174806-17480685.42685.55
15min1190000-19000092.85190.642.8693.1290.912.86
2189060-18906092.39292.67
3188883-18888392.30592.57
4179418-17941887.68087.93
5187443-18744391.60191.87
6178095-17809587.03387.28
20min1189220-18922092.47091.052.9192.8891.452.91
2189725-18972592.71793.13
3192262-19226293.95694.36
4183202-18320289.52989.92
5186156-18615690.97291.38
6177290-17729086.64087.02
30min1190224-19022492.96091.462.7493.5192.002.74
2190248-19024892.97293.52
3193525-19352594.57495.12
4181550-18155088.72289.24
5186568-18656891.17491.72
6180846-18084688.37788.89
45min1193177-19317794.40492.042.7895.0992.722.78
2191152-19115293.41494.11
3193721-19372194.66995.36
4183097-18309789.47890.13
5187469-18746991.61492.30
6181434-18143488.66589.31
60min1195037-19503795.31292.392.4596.1493.202.45
2189647-18964792.67893.51
3193564-19356494.59395.42
4186088-18608890.93991.73
5187078-18707891.42392.24
6182897-18289789.38090.16
120min1192498-19249894.07292.232.4695.0493.182.46
2190811-19081193.24794.22
3194831-19483195.21296.19
4184209-18420990.02190.95
5186353-18635391.06992.03
6183687-18368789.76690.68
180min1193224-19322494.42692.512.2395.5493.612.24
2189272-18927292.49593.61
3195010-19501095.29996.42
4187207-18720791.48692.55
5187684-18768491.71992.81
6183471-18347189.66090.71
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1194060-19406094.83592.602.3496.0993.832.34
2191654-19165493.65994.91
3193933-19393394.77396.03
4186602-18660291.19092.39
5187580-18758091.66892.90
6183136-18313689.49790.68
360min1191676-19167693.67092.422.0595.0793.792.06
2190631-19063193.15994.55
3194674-19467495.13596.54
4186986-18698691.37892.71
5186561-18656191.17092.54
6184203-18420390.01891.33
480min1195722-19572295.64794.151.6897.1995.661.68
2193199-19319994.41495.94
3197157-19715796.34997.89
4190171-19017192.93594.41
5189915-18991592.80994.31
6189804-18980492.75594.20
600min1194390-19439094.99693.432.0496.6895.082.05
2192543-19254394.09495.77
3195976-19597695.77197.46
4189646-18964692.67894.29
5189263-18926392.49194.13
6185290-18529090.54992.14
720min1194005-19400594.80892.762.3096.6394.552.30
2190815-19081593.24995.06
3195597-19559795.58697.42
4187137-18713791.45293.20
5186581-18658191.18092.96
6184765-18476590.29392.02
极限1193652-19365294.63692.792.0896.6094.722.09
2191175-19117593.42595.38
3194519-19451995.05997.04
4188026-18802691.88693.77
5187640-18764091.69893.62
6184233-18423390.03391.89
达格列净二甲双胍缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100664-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数10
标示量(mg)1000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%
110.139617699611819604219608819602419608990.07
210.139648209646659647420.02
单位质量响应值RSD%判断
94856.7695236.130.29数据可信
供试品溶液-2025070821批-二甲双胍-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%
5min149739-497395.2335.016.485.235.016.50
250422-504225.3055.31
345919-459194.8314.83
443931-439314.6224.62
550884-508845.3545.35
644785-447854.7124.71
10min195836-9583610.08310.163.3410.0910.173.36
298580-9858010.37210.38
396620-9662010.16610.17
494516-945169.9449.95
5101599-10159910.68910.70
692345-923459.7169.72
15min1136480-13648014.35914.222.4414.3814.252.44
2137011-13701114.41514.44
3132842-13284213.97714.00
4132716-13271613.96313.99
5140322-14032214.76414.79
6131831-13183113.87013.89
20min1168135-16813517.69017.912.3217.7317.952.32
2177011-17701118.62418.67
3167600-16760017.63417.68
4167645-16764517.63817.68
5173020-17302018.20418.25
6167786-16778617.65317.70
30min1220030-22003023.15023.291.0423.2223.361.04
2221123-22112323.26523.34
3223811-22381123.54823.62
4218788-21878823.01923.09
5224410-22441023.61123.68
6219738-21973823.11923.19
45min1285009-28500929.98630.111.0030.0930.221.00
2284805-28480529.96530.07
3288138-28813830.31630.42
4283748-28374829.85429.96
5291119-29111930.62930.74
6284431-28443129.92630.03
60min1346587-34658736.46535.900.9836.6236.050.98
2336408-33640835.39435.55
3339853-33985335.75735.91
4340895-34089535.86636.01
5342371-34237136.02236.18
6340991-34099135.87636.02
120min1493771-49377151.95152.150.2952.1652.360.28
2494347-49434752.01152.22
3496608-49660852.24952.45
4496194-49619452.20652.41
5497527-49752752.34652.55
6495602-49560252.14352.35
180min1609582-60958264.13563.910.4664.4264.190.46
2602028-60202863.34163.62
3609220-60922064.09764.38
4607359-60735963.90264.18
5608347-60834764.00564.29
6608091-60809163.97964.26
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1694751-69475173.09673.090.2973.4873.470.29
2696936-69693673.32673.71
3693476-69347672.96273.34
4693028-69302872.91573.29
5697176-69717673.35173.73
6692762-69276272.88773.26
360min1817977-81797786.06186.210.4486.5586.700.44
2822354-82235486.52287.01
3819836-81983686.25786.75
4824080-82408086.70387.19
5813893-81389385.63186.12
6818491-81849186.11586.60
480min1906425-90642595.36795.790.6995.9996.410.69
2908385-90838595.57396.19
3907080-90708095.43696.05
4912193-91219395.97496.59
5906307-90630795.35495.98
6922497-92249797.05897.67
600min1945379-94537999.465100.020.30100.23100.780.29
2953265-953265100.295101.06
3951461-951461100.105100.87
4951374-951374100.096100.86
5950161-95016199.968100.73
6952092-952092100.172100.93
720min1959900-959900100.993101.640.78101.90102.560.77
2973499-973499102.424103.34
3972391-972391102.307103.22
4958473-958473100.843101.75
5959475-959475100.948101.86
6972816-972816102.352103.26
极限1966481-966481101.686102.010.65102.75103.070.64
2979808-979808103.088104.15
3973190-973190102.391103.46
4965315-965315101.563102.62
5969891-969891102.044103.11
6962539-962539101.271102.34
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