托伐普坦口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101242-201201对照品来源工作对照品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1000
标示量(mg)15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%
1 16.451964951948471970101965561952541960320.48
2 16.521954791975361965080.75
单位质量响应值RSD%判断
11916.8411895.160.13数据可信
供试品溶液-3B85SDC1批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min118041-180419.0929.443.859.099.443.87
218372-183729.2599.26
318893-188939.5219.52
420092-2009210.12510.13
518470-184709.3089.31
618523-185239.3359.33
10min135923-3592318.10318.251.2818.1218.271.28
235940-3594018.11218.13
337057-3705718.67518.69
435816-3581618.04918.07
536172-3617218.22918.24
636415-3641518.35118.37
15min156986-5698628.71827.233.0228.7627.283.01
253593-5359327.00827.05
354756-5475627.59427.64
452945-5294526.68226.73
553404-5340426.91326.96
652537-5253726.47626.52
20min167825-6782534.18034.491.4634.2734.581.45
267806-6780634.17134.26
369631-6963135.09035.18
469609-6960935.07935.17
568479-6847934.51034.60
667261-6726133.89633.99
30min190548-9054845.63145.810.7445.7845.960.74
290387-9038745.55045.70
391901-9190146.31346.46
490111-9011145.41145.56
591058-9105845.88946.04
691367-9136746.04446.19
45min1116737-11673758.82958.930.7859.0659.160.77
2116345-11634558.63258.86
3117865-11786559.39859.63
4116453-11645358.68658.91
5118240-11824059.58759.81
6116004-11600458.46058.68
60min1134633-13463367.84868.400.6368.1768.720.62
2136089-13608968.58268.90
3137092-13709269.08769.41
4135612-13561268.34168.66
5135810-13581068.44168.77
6135142-13514268.10568.43
90min1161700-16170081.48881.570.4581.9382.010.44
2162694-16269481.98982.42
3162490-16249081.88782.33
4160907-16090781.08981.53
5162172-16217281.72682.16
6161205-16120581.23981.67
120min1176044-17604488.71788.841.0589.2989.411.05
2173395-17339587.38287.95
3178301-17830189.85490.43
4175912-17591288.65189.22
5178326-17832689.86790.44
6175760-17576088.57489.14
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1190659-19065996.08296.360.8696.8097.080.86
2190079-19007995.79096.51
3192129-19212996.82397.55
4191156-19115696.33397.05
5193929-19392997.73098.45
6189291-18929195.39396.11
240min1193758-19375897.64498.740.8998.5399.630.88
2195743-19574398.64499.52
3197633-19763399.597100.49
4194491-19449198.01398.89
5198203-19820399.884100.77
6195825-19582598.68699.56
极限1194737-19473798.13798.891.0599.1899.941.05
2195060-19506098.30099.34
3197593-19759399.577100.63
4194971-19497198.25599.30
5199840-199840100.709101.76
6195171-19517198.35699.40
托伐普坦口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101242-201201对照品来源工作对照品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1000
标示量(mg)15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%
1 16.451981741973031956011978511973981972650.51
2 16.522012592033742023160.74
单位质量响应值RSD%判断
11991.7912246.731.49数据可信
供试品溶液-3B85SDC1批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min118580-185809.2009.057.299.209.057.31
218436-184369.1289.13
317682-176828.7558.75
419812-198129.8109.81
519152-191529.4839.48
615982-159827.9137.91
10min135019-3501917.33917.521.8917.3517.531.89
235741-3574117.69717.71
335239-3523917.44817.46
436242-3624217.94517.96
535680-3568017.66617.68
634331-3433116.99817.01
15min151980-5198025.73726.061.5925.7826.101.59
253577-5357726.52826.57
352888-5288826.18726.23
453457-5345726.46826.51
552457-5245725.97326.02
651449-5144925.47425.52
20min167285-6728533.31533.381.2733.4033.471.28
267765-6776533.55333.64
367295-6729533.32033.41
467628-6762833.48533.58
568582-6858233.95734.05
665981-6598132.66932.75
30min193080-9308046.08745.021.3346.2345.171.33
290770-9077044.94345.09
391274-9127445.19345.34
490580-9058044.84945.00
590398-9039844.75944.90
689470-8947044.30044.44
45min1113834-11383456.36357.541.0656.5857.761.06
2117161-11716158.01058.23
3116777-11677757.82058.04
4116462-11646257.66457.89
5116952-11695257.90758.13
6116030-11603057.45057.66
60min1136079-13607967.37767.400.4867.6967.710.48
2136309-13630967.49167.81
3137031-13703167.84968.16
4135701-13570167.19067.51
5136466-13646667.56967.89
6135138-13513866.91167.22
90min1160827-16082779.63179.780.2380.0680.200.23
2160863-16086379.64980.08
3161234-16123479.83380.26
4161702-16170280.06480.49
5161307-16130779.86980.30
6160783-16078379.60980.03
120min1176733-17673387.50787.770.6988.0788.330.68
2178054-17805488.16188.72
3177195-17719587.73588.30
4175895-17589587.09287.65
5179227-17922788.74189.30
6176463-17646387.37387.93
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1190818-19081894.48194.540.4595.1895.250.45
2190177-19017794.16394.87
3192301-19230195.21595.92
4190389-19038994.26894.98
5190313-19031394.23194.94
6191659-19165994.89795.59
240min1197399-19739997.73997.560.4198.6098.420.41
2196298-19629897.19498.06
3197503-19750397.79198.66
4195797-19579796.94697.81
5197343-19734397.71198.58
6197885-19788597.98098.84
极限1197591-19759197.83497.610.5798.8698.630.56
2196232-19623297.16198.19
3197036-19703697.55998.59
4195468-19546896.78397.81
5198253-19825398.16299.19
6198206-19820698.13999.16
托伐普坦口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101242-201201对照品来源工作对照品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1000
标示量(mg)15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%
1 16.451970411991001985731969951987351980890.51
2 16.521986861964401975630.81
单位质量响应值RSD%判断
12041.8811959.020.49数据可信
供试品溶液-3B85SDC1批-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%
5min126762-2676213.38114.1119.5813.3814.1119.59
226544-2654413.27213.27
324247-2424712.12312.12
428719-2871914.35914.36
538934-3893419.46619.47
624118-2411812.05912.06
10min150035-5003525.01724.322.1925.0424.342.20
248862-4886224.43024.45
347628-4762823.81323.83
449494-4949424.74624.77
548603-4860324.30124.33
647263-4726323.63123.65
15min171690-7169035.84434.682.0935.9134.742.09
268942-6894234.47034.53
368926-6892634.46234.52
469803-6980334.90134.97
569556-6955634.77734.85
667261-6726133.63033.69
20min187961-8796143.97943.191.5744.1043.311.57
285319-8531942.65842.78
388173-8817344.08544.20
485962-8596242.98043.10
585883-8588342.94043.07
684990-8499042.49442.61
30min1112662-11266256.33055.021.4156.5355.211.41
2109782-10978254.89055.08
3107935-10793553.96654.16
4110423-11042355.21055.41
5109958-10995854.97855.18
6109446-10944654.72254.91
45min1137711-13771168.85467.671.9369.1467.961.92
2133897-13389766.94767.23
3132293-13229366.14566.43
4139245-13924569.62169.91
5134167-13416767.08267.38
6134761-13476167.37967.66
60min1160834-16083480.41576.542.5980.8276.942.59
2152741-15274176.36976.76
3150002-15000274.99975.39
4152709-15270976.35376.76
5151842-15184275.91976.32
6150412-15041275.20475.59
90min1174290-17429087.14386.210.6987.6886.740.69
2173087-17308786.54187.06
3171114-17111485.55586.07
4172378-17237886.18786.72
5172395-17239586.19586.73
6171266-17126685.63186.15
120min1183839-18383991.91791.660.5992.6092.340.59
2184506-18450692.25192.92
3182013-18201391.00491.66
4184298-18429892.14792.82
5183228-18322891.61292.29
6182120-18212091.05891.72
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1193208-19320896.60295.781.2097.4496.601.19
2194280-19428097.13797.96
3189486-18948694.74195.55
4190544-19054495.27096.10
5193131-19313196.56397.39
6188701-18870194.34895.16
240min1195573-19557397.78497.560.8698.7898.540.86
2196811-19681198.40399.38
3193025-19302596.51097.48
4196833-19683398.41499.40
5195209-19520997.60298.59
6193276-19327696.63697.60
极限1195678-19567897.83697.621.1199.0098.761.10
2196512-19651298.25399.40
3193698-19369896.84797.98
4198635-19863599.315100.47
5192699-19269996.34797.50
6194193-19419397.09498.22
托伐普坦口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101242-201201对照品来源工作对照品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1000
标示量(mg)15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%
1 16.451979491963291985941980331961551974120.56
2 16.521999591990431995010.33
单位质量响应值RSD%判断
12000.7312076.330.45数据可信
供试品溶液-3B85SDC1批-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%
5min115644-156447.79712.3219.577.8012.3219.56
227393-2739313.65313.65
324182-2418212.05212.05
425494-2549412.70612.71
525924-2592412.92112.92
629734-2973414.82014.82
10min149161-4916124.50224.622.3624.5224.642.37
250092-5009224.96624.99
347879-4787923.86323.88
448342-4834224.09424.12
549917-4991724.87924.90
650992-5099225.41525.44
15min172702-7270236.23534.933.5836.2935.003.57
270895-7089535.33435.40
365766-6576632.77832.84
468592-6859234.18734.25
571104-7110435.43935.50
671483-7148335.62735.69
20min188790-8879044.25343.053.4144.3743.173.40
287990-8799043.85543.98
380759-8075940.25140.37
485799-8579942.76342.88
586900-8690043.31143.43
687992-8799243.85643.98
30min1112818-11281856.22955.162.6056.4255.352.60
2111096-11109655.37155.57
3105172-10517252.41852.60
4110140-11014054.89455.08
5112452-11245256.04756.24
6112321-11232155.98156.18
45min1146370-14637072.95168.194.6173.2368.484.60
2136488-13648868.02668.31
3126727-12672763.16163.43
4135283-13528367.42667.71
5138124-13812468.84269.13
6137926-13792668.74369.04
60min1156158-15615877.83076.153.5778.2376.553.57
2152360-15236075.93776.34
3142345-14234570.94571.32
4152858-15285876.18576.58
5156543-15654378.02278.42
6156494-15649477.99778.40
90min1176114-17611487.77686.123.5388.3186.653.53
2173698-17369886.57287.10
3160712-16071280.10080.59
4173214-17321486.33186.85
5176726-17672688.08188.61
6176333-17633387.88588.42
120min1187305-18730593.35491.592.7094.0392.262.71
2183045-18304591.23091.90
3174380-17438086.91287.54
4184157-18415791.78592.45
5187976-18797693.68894.37
6185776-18577692.59293.28
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1196351-19635197.86295.863.6798.7096.683.67
2193584-19358496.48397.31
3178296-17829688.86489.63
4192979-19297996.18297.00
5196778-19677898.07598.91
6196003-19600397.68998.53
240min1198708-19870899.03796.305.51100.0397.285.48
2194869-19486997.12498.11
3171825-17182585.63886.56
4195872-19587297.62498.60
5199414-19941499.389100.39
6198623-19862398.995100.00
极限1199824-19982499.59396.884.94100.7698.024.92
2195841-19584197.60898.76
3175190-17519087.31688.38
4196314-19631497.84498.98
5200746-200746100.053101.22
6198314-19831498.841100.01
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