艾托格列净片项目信息
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741-2407001对照品来源原料对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0.41对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7719
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.493705013720543703223697343695243704270.27
214.573700993708043704520.14
单位质量响应值RSD%判断
25564.3225425.670.39数据可信
供试品溶液-25102001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%
5min1237390-23739064.03558.7614.3364.0358.7614.33
2173547-17354746.81346.81
3231701-23170162.50062.50
4231938-23193862.56462.56
5248842-24884267.12467.12
6183573-18357349.51849.52
10min1297535-29753580.25976.908.5380.3777.008.53
2274270-27427073.98374.06
3296914-29691480.09180.20
4293097-29309779.06279.17
5307879-30787983.04983.16
6240863-24086364.97265.05
15min1315478-31547885.09982.067.2785.3482.297.28
2301307-30130781.27681.48
3313455-31345584.55384.79
4310652-31065283.79784.03
5322993-32299387.12687.38
6261453-26145370.52670.72
20min1320282-32028286.39584.766.4986.7885.126.50
2312607-31260784.32484.66
3323599-32359987.28987.67
4321807-32180786.80687.18
5332400-33240089.66390.06
6274674-27467474.09274.40
30min1327679-32767988.39088.551.5988.9289.051.61
2320338-32033886.41086.89
3330943-33094389.27089.79
4327752-32775288.41088.93
5336197-33619790.68891.23
6326640-32664088.11088.54
45min1331043-33104389.29790.361.6589.9791.021.64
2327333-32733388.29788.92
3338142-33814291.21291.89
4332694-33269489.74390.41
5341836-34183692.20992.90
6338919-33891991.42292.00
60min1333694-33369490.01291.001.1890.8391.801.18
2332344-33234489.64890.42
3339761-33976191.64992.47
4336502-33650290.77091.59
5342858-34285892.48493.33
6339019-33901991.44992.18
极限1333357-33335789.92192.241.5390.8993.191.51
2347358-34735893.69894.62
3340016-34001691.71892.70
4340713-34071391.90692.87
5347148-34714893.64294.65
6343107-34310792.55293.43
艾托格列净片项目信息
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741-2407001对照品来源原料对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0.41对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7719
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.493703423710663718873717883708913711950.18
214.573730393699993715190.58
单位质量响应值RSD%判断
25617.3225498.900.33数据可信
供试品溶液-25102002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%
5min1237595-23759563.93264.113.9963.9364.113.99
2246267-24626766.26566.27
3240459-24045964.70264.70
4221439-22143959.58559.58
5235930-23593063.48463.48
6247855-24785566.69266.69
10min1295294-29529479.45780.333.6379.5680.443.63
2306619-30661982.50582.62
3305163-30516382.11382.22
4278912-27891275.04975.15
5297749-29774980.11880.22
6307458-30745882.73082.84
15min1317103-31710385.32685.453.5985.5685.693.59
2322935-32293586.89587.14
3324392-32439287.28787.53
4296355-29635579.74379.97
5316086-31608685.05285.29
6328486-32848688.38988.64
20min1325097-32509787.47787.743.1587.8688.123.16
2331622-33162289.23289.63
3330397-33039788.90389.29
4306503-30650382.47382.83
5327112-32711288.01988.40
6335700-33570090.33090.73
30min1332830-33283089.55790.322.3190.0890.852.31
2344022-34402292.56993.11
3337629-33762990.84991.39
4323393-32339387.01887.51
5332882-33288289.57190.10
6343304-34330492.37692.92
45min1334893-33489390.11391.852.2090.7992.532.20
2347225-34722593.43194.13
3344690-34469092.74993.44
4330111-33011188.82689.47
5341634-34163491.92692.60
6349484-34948494.03994.74
60min1340021-34002191.49292.602.1292.3293.432.13
2353449-35344995.10695.96
3345864-34586493.06593.91
4333710-33371089.79490.58
5341248-34124891.82392.65
6350501-35050194.31295.17
极限1339435-33943591.33593.281.8592.3194.271.86
2354129-35412995.28996.30
3347786-34778693.58294.58
4341463-34146391.88092.82
5343051-34305192.30893.29
6354140-35414095.29296.31
艾托格列净片项目信息
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741-2407001对照品来源原料对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0.41对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7719
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.493699763720643709243712563716203711680.22
214.573696553683383689960.26
单位质量响应值RSD%判断
25615.4625325.740.81数据可信
供试品溶液-25102003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%
5min1254202-25420268.63768.254.7968.6468.254.79
2259618-25961870.10070.10
3228513-22851361.70161.70
4255727-25572769.04969.05
5258731-25873169.86069.86
6259806-25980670.15070.15
10min1309605-30960583.59782.173.1483.7182.283.14
2307175-30717582.94083.06
3285336-28533677.04477.15
4305994-30599482.62282.74
5311490-31149084.10684.22
6306218-30621882.68282.80
15min1324054-32405487.49885.633.0287.7585.883.03
2318866-31886686.09786.35
3299024-29902480.74080.97
4319931-31993186.38586.64
5325442-32544287.87388.13
6315532-31553285.19785.45
20min1330518-33051889.24387.821.7989.6488.211.80
2327350-32735088.38888.79
3314466-31446684.90985.27
4325290-32529087.83288.23
5329613-32961388.99989.40
6324132-32413287.51987.92
30min1340447-34044791.92490.511.4592.4791.051.45
2336443-33644390.84391.39
3329960-32996089.09389.60
4336941-33694190.97891.52
5338889-33888991.50492.05
6328553-32855388.71389.26
45min1341142-34114292.11291.611.1492.8192.301.14
2342453-34245392.46693.16
3335068-33506890.47291.13
4339387-33938791.63892.33
5343396-34339692.72193.42
6334225-33422590.24490.93
60min1344674-34467493.06692.801.5693.9293.641.56
2344717-34471793.07793.93
3338841-33884191.49192.30
4347052-34705293.70894.56
5350653-35065394.68095.54
6336126-33612690.75891.60
极限1341696-34169692.26193.812.5393.2794.802.51
2358263-35826396.73597.74
3343254-34325492.68293.64
4351610-35161094.93895.94
5354527-35452795.72696.74
6335193-33519390.50691.50
艾托格列净片项目信息
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741-2407001对照品来源原料对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0.41对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7719
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.493702003696783702083728403691843704220.39
214.573719043708443713740.21
单位质量响应值RSD%判断
25563.9825488.950.21数据可信
供试品溶液-B111406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%
5min1214157-21415757.69657.154.9857.7057.154.97
2211370-21137056.94556.95
3206355-20635555.59455.59
4231967-23196762.49562.49
5206322-20632255.58555.59
6202610-20261054.58554.59
10min1320571-32057186.36580.354.6686.4680.444.66
2284153-28415376.55476.65
3290024-29002478.13678.23
4306314-30631482.52482.63
5301322-30132281.18081.27
6287066-28706677.33977.43
15min1357544-35754496.32688.394.9596.5788.624.95
2314222-31422284.65584.88
3321067-32106786.49986.72
4328574-32857488.52288.76
5332663-33266389.62389.85
6314431-31443184.71184.93
20min1369015-36901599.41792.344.2799.8292.724.27
2327569-32756988.25188.61
3342233-34223392.20192.57
4337744-33774490.99291.38
5347309-34730993.56993.95
6332721-33272189.63990.00
30min1373049-373049100.50494.803.35101.0795.343.35
2339131-33913191.36691.88
3350372-35037294.39494.91
4345437-34543793.06593.61
5355972-35597295.90396.44
6347375-34737593.58794.10
45min1378034-378034101.84796.982.89102.5897.672.90
2348423-34842393.86994.53
3353176-35317695.15095.83
4361991-36199197.52598.22
5362892-36289297.76798.46
6355282-35528295.71796.38
60min1377805-377805101.78597.242.76102.6998.092.77
2350040-35004094.30595.12
3357270-35727096.25397.09
4364527-36452798.20899.07
5362914-36291497.77398.63
6353096-35309695.12895.95
极限1378187-378187101.88898.392.46102.9699.402.46
2354300-35430095.45296.43
3369084-36908499.435100.43
4369958-36995899.671100.69
5356851-35685196.14097.16
6362817-36281797.74798.73
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