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%
114.493848953845503853543850443846783849040.09
214.603869683853263861470.31
单位质量响应值RSD%判断
26563.4226448.420.31数据可信
供试品溶液-2026032321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%
5min1230950-23095060.16860.766.5860.1760.766.57
2210294-21029454.78754.79
3222774-22277458.03858.04
4244535-24453563.70763.71
5252789-25278965.85865.86
6238066-23806662.02262.02
10min1303688-30368879.11876.944.6579.2277.054.66
2274018-27401871.38871.48
3283430-28343073.84173.94
4300023-30002378.16378.27
5310434-31043480.87680.99
6300451-30045178.27578.38
15min1324649-32464984.57981.723.9984.8181.953.99
2295223-29522376.91377.12
3302301-30230178.75778.98
4315062-31506282.08182.32
5326680-32668085.10885.35
6318198-31819882.89883.13
20min1333103-33310386.78284.133.6587.1584.503.65
2306274-30627479.79280.13
3312278-31227881.35681.71
4322779-32277984.09284.47
5336435-33643587.65088.04
6326720-32672085.11985.49
30min1344798-34479889.82886.983.3590.3587.493.35
2320560-32056083.51483.99
3322458-32245884.00884.49
4333628-33362886.91887.43
5347880-34788090.63191.16
6333977-33397787.00987.52
45min1354166-35416692.26990.173.2192.9490.823.21
2343264-34326489.42990.04
3331682-33168286.41187.04
4341762-34176289.03789.70
5363442-36344294.68695.37
6342260-34226089.16789.83
60min1361713-36171394.23592.583.5095.0693.383.49
2357782-35778293.21193.97
3339035-33903588.32789.10
4350238-35023891.24692.05
5374966-37496697.68898.53
6348423-34842390.77391.58
极限1373799-37379997.38496.942.2698.3697.902.27
2363673-36367394.74695.66
3365904-36590495.32796.24
4365372-36537295.18896.15
5381076-38107699.280100.28
6382816-38281699.733100.69
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%
114.493857463867473857833858793858383859990.11
214.603867273859843863560.14
单位质量响应值RSD%判断
26638.9926462.740.47数据可信
供试品溶液-2026032421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%
5min1256905-25690566.81762.754.4366.8262.754.44
2238365-23836561.99562.00
3240666-24066662.59462.59
4250608-25060865.17965.18
5230007-23000759.82159.82
6231089-23108960.10360.10
10min1318744-31874482.90179.063.1283.0179.173.12
2298429-29842977.61777.72
3306865-30686579.81179.92
4309542-30954280.50780.62
5293531-29353176.34376.44
6296827-29682777.20077.30
15min1336531-33653187.52784.152.8887.7884.392.88
2315080-31508081.94882.18
3326804-32680484.99785.23
4330168-33016885.87286.11
5312183-31218381.19481.42
6320601-32060183.38483.61
20min1343023-34302389.21586.312.3489.6186.682.35
2324874-32487484.49584.86
3333960-33396086.85887.24
4337489-33748987.77688.16
5322746-32274683.94284.30
6328922-32892285.54885.92
30min1348508-34850890.64288.482.0391.1989.002.03
2334076-33407686.88887.40
3344298-34429889.54790.07
4345150-34515089.76890.30
5331035-33103586.09786.60
6338002-33800287.90988.42
45min1359521-35952193.50690.941.9394.2091.611.94
2343158-34315889.25089.91
3352593-35259391.70492.38
4354105-35410592.09892.78
5343320-34332089.29389.94
6345253-34525389.79590.45
60min1362011-36201194.15492.031.6095.0092.851.61
2348263-34826390.57891.38
3357570-35757092.99993.82
4356579-35657992.74193.58
5349020-34902090.77591.57
6349640-34964090.93691.74
极限1377865-37786598.27796.500.9899.2997.470.99
2367538-36753895.59196.55
3370722-37072296.41997.40
4368674-36867495.88796.88
5369901-36990196.20697.15
6371419-37141996.60197.56
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%
114.493857503876773854933853123875023863470.30
214.603840173839043839600.03
单位质量响应值RSD%判断
26663.0126298.630.98数据可信
供试品溶液-2026032421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%
5min1237325-23732561.89062.353.9861.8962.343.98
2238792-23879262.27362.27
3246259-24625964.22064.22
4221276-22127657.70557.70
5245667-24566764.06664.07
6245124-24512463.92463.92
10min1302162-30216278.79980.952.3278.9081.052.32
2304888-30488879.51079.61
3315933-31593382.39082.50
4311616-31161681.26481.36
5321124-32112483.74483.85
6306691-30669179.98080.09
15min1319232-31923283.25086.212.6783.4886.442.67
2324392-32439284.59684.83
3336886-33688687.85488.10
4335654-33565487.53387.76
5341906-34190689.16389.41
6325369-32536984.85185.09
20min1329524-32952485.93488.472.3086.3188.852.30
2333196-33319686.89287.27
3345127-34512790.00390.39
4344762-34476289.90890.29
5348376-34837690.85091.25
6334426-33442687.21387.59
30min1340416-34041688.77590.721.8889.2991.251.88
2341402-34140289.03289.55
3353126-35312692.08992.63
4352959-35295992.04692.57
5354925-35492592.55893.10
6344466-34446689.83190.36
45min1346096-34609690.25692.892.0890.9293.582.07
2350401-35040191.37992.05
3358793-35879393.56794.26
4365485-36548595.31295.99
5362432-36243294.51695.22
6354073-35407392.33693.01
60min1350325-35032591.35993.681.6792.1794.521.67
2354542-35454292.45893.28
3362462-36246294.52495.37
4365069-36506995.20496.04
5364852-36485295.14796.01
6358186-35818693.40994.24
极限1371425-37142596.86197.751.5197.8398.741.50
2368430-36843096.08097.06
3377839-37783998.53499.54
4382881-38288199.849100.85
5378200-37820098.62899.64
6370291-37029196.56697.55
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%
114.493772723770093771943767863769383770400.06
214.603743233744643743940.03
单位质量响应值RSD%判断
26020.7025643.421.04数据可信
供试品溶液-2026032321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%
5min1223582-22358259.77161.262.7459.7761.262.73
2235190-23519062.87462.87
3233101-23310162.31662.32
4226799-22679960.63160.63
5220872-22087259.04759.05
6235368-23536862.92262.92
10min1289010-28901077.26279.392.1177.3679.492.11
2302322-30232280.82180.93
3300733-30073380.39680.50
4298336-29833679.75579.86
5289184-28918477.30977.41
6302160-30216080.77880.88
15min1306782-30678282.01384.822.3682.2485.062.36
2323405-32340586.45786.70
3322196-32219686.13486.37
4319263-31926385.35085.58
5308977-30897782.60082.83
6323159-32315986.39186.63
20min1315032-31503284.21987.412.6784.5887.782.67
2332436-33243688.87189.25
3332062-33206288.77189.15
4329687-32968788.13788.51
5316948-31694884.73185.10
6335551-33555189.70490.09
30min1324060-32406086.63290.062.7787.1490.582.76
2342130-34213091.46391.99
3342098-34209891.45491.98
4341924-34192491.40891.93
5325907-32590787.12687.63
6345136-34513692.26792.80
45min1331074-33107488.50792.583.1989.1693.253.19
2350934-35093493.81794.50
3353849-35384994.59695.28
4354187-35418794.68695.36
5333279-33327989.09789.75
6354545-35454594.78295.47
60min1336274-33627489.89794.023.3590.6994.843.34
2356416-35641695.28296.12
3356683-35668395.35396.19
4362331-36233196.86397.70
5337374-33737490.19190.99
6361097-36109796.53397.38
极限1348884-34888493.26997.953.6294.2298.933.61
2373260-37326099.785100.78
3375018-375018100.255101.25
4372337-37233799.538100.53
5350202-35020293.62194.57
6378719-378719101.244102.25
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%
114.493736053728943734443732093730803732460.08
214.603726263724353725300.04
单位质量响应值RSD%判断
25758.8725515.750.68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%
5min1265536-26553671.52466.154.3671.5266.144.36
2239082-23908264.39864.40
3240225-24022564.70664.71
4242898-24289865.42665.43
5249202-24920267.12467.12
6236465-23646563.69363.69
10min1315023-31502384.85381.362.8484.9781.472.84
2300577-30057780.96281.07
3299894-29989480.77880.89
4300303-30030380.88981.00
5307172-30717282.73982.85
6289287-28928777.92178.03
15min1330622-33062289.05586.352.7889.3286.602.78
2320855-32085586.42486.67
3318104-31810485.68385.93
4321532-32153286.60786.85
5327440-32744088.19888.45
6305029-30502982.16282.40
20min1336792-33679290.71788.642.8191.1389.042.81
2330868-33086889.12189.51
3324524-32452487.41387.80
4334229-33422990.02790.41
5335654-33565490.41190.81
6312518-31251884.17984.55
30min1343059-34305992.40591.153.4292.9791.693.42
2341286-34128691.92892.46
3331159-33115989.20089.73
4351209-35120994.60095.14
5344881-34488192.89693.44
6318900-31890085.89886.41
45min1348402-34840293.84493.023.7794.5693.723.75
2348451-34845193.85794.55
3335653-33565390.41091.09
4364044-36404498.05898.75
5349384-34938494.10994.81
6326219-32621987.86988.53
60min1351072-35107294.56393.963.6395.4394.813.61
2353554-35355495.23296.08
3339258-33925891.38192.21
4367264-36726498.92599.78
5351371-35137194.64495.50
6330579-33057989.04489.85
极限1356566-35656696.04396.972.2097.0797.972.20
2364259-36425998.11599.12
3355287-35528795.69996.68
4373833-373833100.694101.72
5358265-35826596.50197.52
6351843-35184394.77195.72
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%
114.493737153735663734803735963738093736330.04
214.603724853729263727060.09
单位质量响应值RSD%判断
25785.5825527.810.72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%
5min1248470-24847066.87768.953.0166.8868.953.01
2260923-26092370.22870.23
3245761-24576166.14766.15
4255035-25503568.64468.64
5263863-26386371.02071.02
6262970-26297070.77970.78
10min1324844-32484487.43387.051.8487.5487.161.84
2323412-32341287.04887.16
3314922-31492284.76284.87
4319801-31980186.07686.19
5324794-32479487.41987.54
6332748-33274889.56089.68
15min1346459-34645993.25192.491.6993.5192.761.69
2342627-34262792.21992.48
3334564-33456490.04990.30
4342015-34201592.05592.31
5343975-34397592.58292.85
6352258-35225894.81295.08
20min1354136-35413695.31794.391.6795.7394.801.67
2349150-34915093.97594.39
3341801-34180191.99792.40
4350651-35065194.37994.79
5349104-34910493.96394.38
6359282-35928296.70297.13
30min1359652-35965296.80295.581.7097.3796.161.70
2353323-35332395.09895.67
3346292-34629293.20693.76
4355582-35558295.70696.27
5352330-35233094.83195.41
6363591-36359197.86298.45
45min1361206-36120697.22095.951.4197.9596.681.41
2354919-35491995.52896.26
3349739-34973994.13494.84
4356408-35640895.92996.66
5353453-35345395.13395.87
6363270-36327097.77598.52
60min1362503-36250397.56996.161.3698.4697.051.36
2354109-35410995.31096.20
3352694-35269494.92995.80
4357115-35711596.11997.01
5353245-35324595.07795.97
6363854-36385497.93398.85
极限1361376-36137697.26696.281.3298.3297.341.32
2352826-35282694.96496.01
3361034-36103497.17498.20
4356264-35626495.89096.94
5351930-35193094.72395.77
6362956-36295697.69198.77
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