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-D对照品来源自制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%
114.273709983703943709213706433705883707090.07
214.323713003714633713820.04
单位质量响应值RSD%判断
25978.2125934.500.12数据可信
供试品溶液-2026032521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%
5min1263747-26374769.88071.712.9969.8871.712.99
2280393-28039374.29074.29
3258964-25896468.61268.61
4270619-27061971.70071.70
5273082-27308272.35372.35
6277090-27709073.41573.41
10min1314840-31484083.41784.583.0083.5384.703.00
2328591-32859187.06087.18
3303036-30303680.28980.40
4319401-31940184.62584.74
5328382-32838287.00487.13
6321134-32113485.08485.21
15min1333409-33340988.33689.112.9088.5989.372.90
2340036-34003690.09290.36
3318765-31876584.45684.70
4339407-33940789.92690.19
5347668-34766892.11492.38
6338680-33868089.73390.00
20min1347777-34777792.14391.823.0692.5592.233.05
2349312-34931292.55092.97
3326139-32613986.41086.80
4351892-35189293.23393.64
5356753-35675394.52194.94
6347530-34753092.07892.49
30min1357961-35796194.84193.682.8595.4094.242.84
2352426-35242693.37593.95
3334282-33428288.56889.10
4359677-35967795.29695.86
5362107-36210795.94096.52
6354989-35498994.05494.62
45min1363960-36396096.43194.882.6197.1595.602.61
2355986-35598694.31895.05
3340461-34046190.20590.89
4363083-36308396.19896.92
5365790-36579096.91697.65
6359409-35940995.22595.95
60min1362261-36226195.98195.482.5396.8696.352.53
2357000-35700094.58795.47
3343571-34357191.02991.86
4365579-36557996.86097.74
5368571-36857197.65398.55
6365166-36516696.75097.63
极限1363397-36339796.28295.722.1497.3296.762.14
2361520-36152095.78496.83
3345926-34592691.65392.64
4365656-36565696.88097.93
5365293-36529396.78497.84
6365895-36589596.94497.99
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-D对照品来源自制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%
114.273710723746633746463715783746583733230.50
214.323717123724503720810.15
单位质量响应值RSD%判断
26161.3925983.310.49数据可信
供试品溶液-2026032521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%
5min1273061-27306172.02670.092.2072.0370.092.20
2270510-27051071.35371.35
3266411-26641170.27270.27
4266192-26619270.21470.21
5257687-25768767.97167.97
6260426-26042668.69368.69
10min1320974-32097484.66482.551.8184.7882.671.81
2316429-31642983.46583.58
3309115-30911581.53681.65
4315298-31529883.16783.28
5305347-30534780.54280.66
6310614-31061481.93282.05
15min1335135-33513588.40086.961.5388.6687.221.53
2333250-33325087.90288.16
3325287-32528785.80286.05
4333916-33391688.07888.33
5323304-32330485.27985.53
6327208-32720886.30986.56
20min1341540-34154090.08989.411.1790.5089.811.17
2342181-34218190.25890.66
3333459-33345987.95888.35
4343334-34333490.56290.96
5335931-33593188.61089.00
6337404-33740488.99889.39
30min1347151-34715191.56991.481.0392.1392.031.03
2351193-35119392.63593.19
3343784-34378490.68191.22
4350985-35098592.58093.13
5344032-34403290.74691.28
6343785-34378590.68191.22
45min1351685-35168592.76592.481.0193.4893.181.01
2356952-35695294.15494.86
3347203-34720391.58392.28
4350854-35085492.54693.25
5348137-34813791.82992.52
6348893-34889392.02992.72
60min1352045-35204592.86093.111.0593.7393.961.05
2359093-35909394.71995.59
3350101-35010192.34793.19
4355827-35582793.85894.72
5350273-35027392.39393.23
6350587-35058792.47593.32
极限1351850-35185092.80994.111.0193.8395.121.01
2361777-36177795.42796.45
3356027-35602793.91094.91
4359975-35997594.95295.97
5354660-35466093.55094.55
6356406-35640694.01095.01
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-D对照品来源自制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%
114.273710213737213711353743473720213724490.41
214.323707623712793710200.10
单位质量响应值RSD%判断
26100.1425909.220.52数据可信
供试品溶液-2026032521批-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%
5min1262040-26204069.29969.512.5469.3069.502.54
2266030-26603070.35470.35
3264660-26466069.99269.99
4272925-27292572.17872.18
5256577-25657767.85467.85
6254685-25468567.35467.35
10min1309440-30944081.83583.462.0881.9583.582.08
2314198-31419883.09383.21
3316821-31682183.78683.90
4327103-32710386.50686.63
5316653-31665383.74283.86
6309376-30937681.81881.93
15min1328199-32819986.79688.662.1887.0588.912.18
2333573-33357388.21788.47
3333364-33336488.16188.42
4348599-34859992.19092.45
5337628-33762889.28989.54
6330054-33005487.28687.53
20min1335854-33585488.82090.531.9489.2290.941.93
2338479-33847989.51489.92
3344644-34464491.14591.55
4350885-35088592.79593.21
5348518-34851892.16992.57
6335595-33559588.75189.15
30min1342913-34291390.68792.431.8291.2392.991.82
2344895-34489591.21191.76
3348128-34812892.06692.62
4360234-36023495.26795.84
5353523-35352393.49394.05
6347414-34741491.87792.42
45min1350471-35047192.68694.091.2393.3894.801.23
2352537-35253793.23293.94
3352876-35287693.32294.03
4360406-36040695.31396.04
5357692-35769294.59595.31
6360626-36062695.37196.07
60min1354267-35426793.68994.191.0694.5495.061.06
2351663-35166393.00193.86
3356665-35666594.32495.19
4361945-36194595.72096.61
5358740-35874094.87295.74
6353687-35368793.53694.39
极限1362367-36236795.83295.240.8896.8496.260.88
2357587-35758794.56795.58
3356836-35683694.36995.39
4364290-36429096.34097.39
5362101-36210195.76196.79
6357675-35767594.59195.60
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-D对照品来源自制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%
114.273702953701973707373741203707113712120.45
214.323699863729463714660.57
单位质量响应值RSD%判断
26013.4525940.360.20数据可信
供试品溶液-2026032521批-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%
5min1255414-25541467.61869.303.0267.6269.303.02
2271795-27179571.95571.95
3268770-26877071.15471.15
4252790-25279066.92466.92
5265339-26533970.24670.25
6256424-25642467.88667.89
10min1303221-30322180.27583.533.0280.3983.653.02
2327722-32772286.76186.88
3325156-32515686.08286.20
4307997-30799781.53981.65
5313584-31358483.01883.14
6315422-31542283.50583.62
15min1323535-32353585.65388.532.6885.9088.782.68
2342482-34248290.66990.93
3346875-34687591.83292.09
4326869-32686986.53586.78
5332110-33211087.92388.18
6334442-33444288.54088.79
20min1333005-33300588.16090.692.4188.5591.102.41
2351220-35122092.98293.40
3352153-35215393.22993.64
4334023-33402388.42988.82
5340384-34038490.11390.52
6344649-34464991.24291.64
30min1337765-33776589.42092.292.3189.9692.852.31
2354628-35462893.88494.45
3358958-35895895.03095.60
4341179-34117990.32490.86
5348231-34823192.19192.74
6350962-35096292.91493.47
45min1348254-34825492.19793.681.5492.8894.381.55
2356068-35606894.26594.99
3362259-36225995.90496.63
4347601-34760192.02492.71
5353835-35383593.67494.38
6355090-35509094.00694.71
60min1351705-35170593.11094.421.4293.9595.291.42
2358782-35878294.98495.87
3362366-36236695.93396.82
4349256-34925692.46293.30
5358958-35895895.03095.89
6358951-35895195.02995.89
极限1354176-35417693.76494.661.4094.7695.681.41
2356796-35679694.45895.50
3363720-36372096.29197.34
4350505-35050592.79393.79
5362564-36256495.98597.01
6357578-35757894.66595.69
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