盐酸达泊西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSZJ-4057-240226对照品来源自制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2000
标示量(mg)60供试品稀释倍数10系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.762101882098812097022094602093312097120.17
215.792100242107942104090.26
单位质量响应值RSD%判断
13306.6013325.460.11数据可信
供试品溶液-2024042221批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min128207-2820714.19420.6128.0614.1920.6028.08
234423-3442317.32117.32
351290-5129025.80925.81
436157-3615718.19418.19
558563-5856329.46829.47
637067-3706718.65218.65
10min1122602-12260261.69266.626.4361.7766.736.45
2141787-14178771.34671.44
3135700-13570068.28368.43
4122860-12286061.82261.92
5140892-14089270.89671.06
6130471-13047165.65265.76
15min1155981-15598178.48881.642.9178.9182.122.94
2162826-16282681.93382.43
3165721-16572183.38983.91
4163616-16361682.33082.77
5168018-16801884.54585.10
6157311-15731179.15779.63
20min1159466-15946680.24282.732.1881.1083.672.19
2163997-16399782.52283.47
3169174-16917485.12786.11
4167833-16783384.45285.35
5163711-16371182.37883.41
6162334-16233481.68582.59
30min1164789-16478982.92082.941.0984.2284.341.11
2163573-16357382.30883.71
3168302-16830284.68886.15
4164283-16428382.66684.04
5164650-16465082.85084.34
6163387-16338782.21583.58
45min1159240-15924080.12882.932.0081.8984.792.03
2164816-16481682.93484.80
3168286-16828684.68086.61
4165903-16590383.48185.31
5167447-16744784.25886.20
6163213-16321382.12783.95
60min1158902-15890279.95882.182.0682.1784.502.06
2161387-16138781.20883.53
3166956-16695684.01186.41
4167257-16725784.16286.46
5164005-16400582.52684.94
6161422-16142281.22683.50
极限1155183-15518378.08781.202.3480.7483.982.36
2160019-16001980.52083.30
3165277-16527783.16686.03
4162382-16238281.70984.47
5165045-16504583.04985.92
6160304-16030480.66383.39
盐酸达泊西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSZJ-4057-240226对照品来源自制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2000
标示量(mg)60供试品稀释倍数10系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.762088222095002102042105312108942099900.40
215.792094992089702092340.18
单位质量响应值RSD%判断
13324.2413251.040.39数据可信
供试品溶液-2024042221批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min161018-6101830.77031.206.4330.7731.206.44
258029-5802929.26229.26
364864-6486432.70932.71
468377-6837734.48034.48
560132-6013230.32330.32
658817-5881729.66029.66
10min1151945-15194576.62173.846.4276.7974.026.42
2135434-13543468.29568.46
3154312-15431277.81578.00
4154552-15455277.93678.13
5148503-14850374.88675.05
6133862-13386267.50367.67
15min1165166-16516683.28881.261.7783.8881.841.77
2163087-16308782.24082.78
3162455-16245581.92182.54
4159592-15959280.47781.10
5158079-15807979.71480.30
6158472-15847279.91380.45
20min1165202-16520283.30681.192.6184.3782.222.57
2165014-16501483.21284.21
3162346-16234681.86682.94
4154152-15415277.73478.81
5158670-15867080.01281.04
6160591-16059180.98181.96
30min1161620-16162081.50080.951.9183.0282.441.87
2164070-16407082.73584.20
3158577-15857779.96681.49
4156184-15618478.75980.26
5163499-16349982.44883.92
6159207-15920780.28381.72
45min1163151-16315182.27280.722.3084.2582.662.25
2162501-16250181.94483.87
3158890-15889080.12382.09
4154405-15440577.86279.80
5163718-16371882.55884.49
6157821-15782179.58481.46
60min1159465-15946580.41379.720.9382.8582.110.91
2159743-15974380.55482.93
3156458-15645878.89781.31
4156357-15635778.84681.22
5158686-15868680.02082.41
6157877-15787779.61381.93
极限1154280-15428077.79978.331.7680.6881.161.69
2157092-15709279.21782.04
3155126-15512678.22581.08
4150743-15074376.01578.83
5158639-15863979.99782.83
6156172-15617278.75381.52
盐酸达泊西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSZJ-4057-240226对照品来源自制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2000
标示量(mg)60供试品稀释倍数10系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.762087912086272087312085922084002086280.08
215.792108352109762109060.05
单位质量响应值RSD%判断
13237.8213356.930.64数据可信
供试品溶液-2024042321批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min150110-5011025.25127.518.8725.2527.518.87
256448-5644828.44528.44
361035-6103530.75630.76
457486-5748628.96828.97
547978-4797824.17624.18
654503-5450327.46427.46
10min1140916-14091671.00870.915.5971.1571.065.56
2133033-13303367.03667.19
3131655-13165566.34266.51
4141901-14190171.50571.67
5143494-14349472.30872.44
6153287-15328777.24277.39
15min1165888-16588883.59282.251.7884.1382.791.77
2165012-16501283.15183.68
3165674-16567483.48484.02
4159527-15952780.38780.94
5159743-15974380.49681.03
6163445-16344582.36182.94
20min1167307-16730784.30781.881.8385.3182.881.81
2158967-15896780.10581.10
3164517-16451782.90183.90
4161015-16101581.13782.14
5161321-16132181.29182.27
6161794-16179481.52982.57
30min1166839-16683984.07181.881.3685.5483.341.34
2162578-16257881.92483.36
3161506-16150681.38482.85
4160937-16093781.09782.55
5161249-16124981.25482.69
6161824-16182481.54483.04
45min1163935-16393582.60880.661.7684.5482.581.72
2158105-15810579.67081.56
3162904-16290482.08884.00
4159081-15908180.16282.07
5159774-15977480.51182.40
6156653-15665378.93880.88
60min1165066-16506683.17880.291.9985.5782.651.95
2158083-15808379.65981.99
3159818-15981880.53382.91
4156300-15630078.76181.11
5156942-15694279.08481.42
6159813-15981380.53182.91
极限1161423-16142381.34280.261.3284.2083.061.31
2157750-15775079.49182.27
3160186-16018680.71983.54
4159675-15967580.46183.25
5155833-15583378.52581.30
6160734-16073480.99583.83
盐酸达泊西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSZJ-4057-240226对照品来源自制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2000
标示量(mg)60供试品稀释倍数10系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.762097272101282104442107492104742103040.19
215.792128872131032129950.08
单位质量响应值RSD%判断
13344.1613489.230.77数据可信
供试品溶液-2024042321批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min157490-5749028.71225.3620.1228.7125.3620.12
248424-4842424.18424.18
338590-3859019.27319.27
462262-6226231.09531.10
558533-5853329.23329.23
639363-3936319.65919.66
10min1128388-12838864.12169.474.3164.2869.614.30
2136316-13631668.08068.21
3139637-13963769.73969.85
4143434-14343471.63571.81
5142984-14298471.41071.57
6143866-14386671.85171.96
15min1158077-15807778.94881.951.9479.4682.481.94
2165769-16576982.79083.30
3163132-16313281.47381.97
4166368-16636883.08983.66
5166135-16613582.97383.53
6165084-16508482.44882.96
20min1160455-16045580.13681.461.0981.0982.441.10
2164824-16482482.31883.29
3162456-16245681.13582.08
4165071-16507182.44183.47
5163683-16368381.74882.77
6162108-16210880.96281.93
30min1156766-15676678.29480.521.6079.6981.951.58
2163932-16393281.87283.30
3161840-16184080.82882.23
4161784-16178480.80082.29
5159918-15991879.86881.34
6163094-16309481.45482.87
45min1157030-15703078.42580.741.8680.2682.631.83
2165004-16500482.40884.29
3164658-16465882.23584.08
4160625-16062580.22182.16
5162401-16240181.10883.03
6160323-16032380.07081.94
60min1155935-15593577.87980.211.8480.1582.551.82
2165099-16509982.45584.80
3160926-16092680.37182.67
4161405-16140580.61083.00
5159738-15973879.77882.15
6160574-16057480.19582.51
极限1154732-15473277.27879.941.8379.9882.721.81
2159721-15972179.76982.57
3160589-16058980.20382.95
4160746-16074680.28183.11
5163558-16355881.68684.50
6161044-16104480.43083.19
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