达格列净二甲双胍缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号101568-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)80.4对照品水分(%)0对照品稀释倍数1250
标示量(mg)10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%
112.651654671650961651891651351653531652480.10
212.621680451679251679850.06
单位质量响应值RSD%判断
13063.0813311.011.33数据可信
供试品溶液-WK2170批-达格列净-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%
5min1110066-11006653.69063.6412.2953.6963.6412.29
2141168-14116868.86168.86
3140400-14040068.48668.49
4109756-10975653.53853.54
5137763-13776367.20067.20
6143604-14360470.04970.05
10min1183096-18309689.31388.784.1089.3988.874.10
2180823-18082388.20488.31
3184304-18430489.90290.01
4169903-16990382.87882.96
5180801-18080188.19488.29
6193039-19303994.16394.27
15min1195148-19514895.19292.733.2495.4192.963.25
2186355-18635590.90391.14
3190540-19054092.94493.18
4182188-18218888.87089.07
5187355-18735591.39191.62
6199024-19902497.08397.33
20min1199118-19911897.12994.053.3397.4994.423.33
2188445-18844591.92292.29
3192342-19234293.82394.20
4184502-18450289.99990.34
5191013-19101393.17593.55
6201433-20143398.25898.65
30min1203833-20383399.42994.953.7099.9395.463.69
2189162-18916292.27292.78
3193107-19310794.19794.71
4186545-18654590.99691.47
5192241-19224193.77494.28
6203031-20303199.03799.58
45min1205173-205173100.08295.733.15100.7396.383.14
2192331-19233193.81894.47
3194653-19465394.95195.61
4189596-18959692.48493.09
5193190-19319094.23794.89
6202507-20250798.78299.47
60min1205646-205646100.31395.593.28101.1296.393.27
2190005-19000592.68393.47
3194790-19479095.01795.82
4189895-18989592.63093.38
5193743-19374394.50795.30
6201759-20175998.41799.25
120min1212446-212446103.63098.323.50104.5899.263.49
2195760-19576095.49196.42
3198674-19867496.91297.86
4196042-19604295.62896.52
5198144-19814496.65497.59
6208353-208353101.633102.62
180min1212081-212081103.45298.433.24104.5699.523.23
2196631-19663195.91696.99
3199026-19902697.08498.17
4196383-19638395.79596.83
5198871-19887197.00898.09
6207720-207720101.325102.46
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1211354-211354103.09798.183.15104.3699.413.14
2196033-19603395.62496.84
3199169-19916997.15498.39
4196580-19658095.89197.06
5197627-19762796.40197.63
6206884-206884100.917102.20
360min1207888-207888101.40797.413.00102.8298.792.99
2193227-19322794.25595.61
3197686-19768696.43097.81
4195989-19598995.60296.92
5196982-19698296.08797.46
6206376-206376100.669102.11
480min1210440-210440102.65197.383.44104.2298.913.43
2194215-19421594.73796.24
3196587-19658795.89497.42
4194487-19448794.87096.33
5196058-19605895.63697.15
6206015-206015100.493102.08
600min1209067-209067101.98296.693.47103.7198.363.46
2192279-19227993.79395.43
3196719-19671995.95897.63
4192984-19298494.13795.74
5194014-19401494.63996.30
6204205-20420599.610101.35
720min1207891-207891101.40896.173.53103.2997.993.53
2191144-19114493.23995.02
3194202-19420294.73196.54
4191429-19142993.37895.12
5194599-19459994.92496.72
6203684-20368499.356101.25
极限1208093-208093101.50796.013.47103.5497.973.46
2191061-19106193.19895.12
3194336-19433694.79696.75
4191821-19182193.56995.45
5193398-19339894.33896.28
6202232-20223298.648100.69
达格列净二甲双胍缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100664-202106对照品来源中检院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10
标示量(mg)1000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%
19.358921428920568890388954748976118932640.38
29.379125209135019130100.08
单位质量响应值RSD%判断
95536.2697439.701.40数据可信
供试品溶液-WK2170批-二甲双胍-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%
5min130668-306683.1793.436.453.183.436.43
234529-345293.5793.58
331757-317573.2923.29
431741-317413.2903.29
536401-364013.7733.77
633689-336893.4923.49
10min169342-693427.1877.956.727.197.966.74
279788-797888.2708.28
377378-773788.0208.03
471614-716147.4237.43
582412-824128.5428.55
679887-798878.2808.29
15min1107118-10711811.10311.854.3011.1211.864.29
2115258-11525811.94611.96
3115259-11525911.94711.96
4109833-10983311.38411.40
5118895-11889512.32312.34
6119405-11940512.37612.39
20min1136118-13611814.10914.994.3714.1415.024.38
2145358-14535815.06615.10
3145905-14590515.12315.16
4138157-13815714.32014.35
5150263-15026315.57515.61
6151789-15178915.73315.77
30min1186058-18605819.28520.183.5519.3420.243.55
2192908-19290819.99520.05
3196945-19694520.41320.47
4188052-18805219.49219.55
5200648-20064820.79720.86
6203395-20339521.08221.14
45min1248218-24821825.72826.792.7025.8126.882.70
2262761-26276127.23527.32
3258955-25895526.84126.93
4252055-25205526.12526.21
5262518-26251827.21027.30
6266251-26625127.59727.69
60min1299086-29908631.00031.842.5631.1231.972.57
2301115-30111531.21131.34
3309091-30909132.03732.17
4301650-30165031.26631.39
5314171-31417132.56432.70
6318209-31820932.98233.12
120min1466827-46682748.38749.102.1348.5549.282.13
2459188-45918847.59547.77
3469266-46926648.63948.82
4481439-48143949.90150.07
5481787-48178749.93750.12
6483857-48385750.15250.33
180min1577735-57773559.88260.421.7460.1260.661.74
2567986-56798658.87259.12
3584852-58485260.62060.87
4580015-58001560.11960.36
5589428-58942861.09461.35
6597329-59732961.91362.17
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1665687-66568768.99869.181.3969.3369.521.38
2651635-65163567.54267.88
3673628-67362869.82270.16
4664534-66453468.87969.21
5670936-67093669.54269.89
6678046-67804670.27970.63
360min1776877-77687780.52381.541.8580.9681.991.85
2763192-76319279.10579.54
3796552-79655282.56383.01
4787401-78740181.61482.05
5793292-79329282.22582.68
6802960-80296083.22783.68
480min1868399-86839990.01089.891.3590.5690.461.36
2846883-84688387.77988.33
3872441-87244190.42891.00
4862443-86244389.39289.95
5872635-87263590.44991.02
6880941-88094191.30991.89
600min1910169-91016994.33994.151.3295.0394.851.32
2887046-88704691.94292.63
3915285-91528594.86995.57
4905257-90525793.83094.52
5910173-91017394.33995.05
6922260-92226095.59296.31
720min1929214-92921496.31396.141.4297.1496.981.42
2905669-90566993.87394.70
3933625-93362596.77097.62
4919315-91931595.28796.12
5935606-93560696.97697.83
6941941-94194197.63298.49
极限1933016-93301696.70796.381.2797.6897.361.27
2907034-90703494.01494.98
3935958-93595897.01298.00
4928982-92898296.28997.27
5934402-93440296.85197.85
6939774-93977497.40898.41
达格列净二甲双胍缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号101568-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)80.4对照品水分(%)0对照品稀释倍数1250
标示量(mg)10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%
112.651662491656971655191657631659351658330.17
212.621680921682171681540.06
单位质量响应值RSD%判断
13109.3313324.411.16数据可信
供试品溶液-WK2170批-达格列净-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%
5min1132921-13292164.69062.2310.4964.6962.2310.49
2142365-14236569.28769.29
3139799-13979968.03868.04
4127936-12793662.26462.26
5115220-11522056.07656.08
6108899-10889952.99953.00
10min1177882-17788286.57286.584.3086.6786.684.30
2187369-18736991.18991.29
3186040-18604090.54390.64
4173022-17302284.20784.30
5167599-16759981.56881.65
6175514-17551485.42085.50
15min1187514-18751491.26090.513.8391.4990.733.83
2191484-19148493.19293.43
3195971-19597195.37695.61
4179366-17936687.29487.51
5177438-17743886.35686.56
6184071-18407189.58489.79
20min1189515-18951592.23491.843.8092.6092.203.80
2194990-19499094.89895.28
3198317-19831796.51896.90
4180981-18098188.08088.43
5180773-18077387.97988.32
6187643-18764391.32391.66
30min1192972-19297293.91693.144.0594.4293.634.05
2196664-19666495.71396.24
3203029-20302998.81199.34
4184682-18468289.88290.36
5182484-18248488.81289.28
6188376-18837691.67992.16
45min1193622-19362294.23393.343.2694.8893.983.27
2194418-19441894.62095.29
3201843-20184398.23498.91
4185186-18518690.12790.74
5185734-18573490.39490.99
6189924-18992492.43393.05
60min1195825-19582595.30593.753.2696.0994.523.27
2196007-19600795.39396.20
3201269-20126997.95498.78
4184913-18491389.99490.75
5186321-18632190.67991.42
6191391-19139193.14793.90
120min1199140-19914096.91896.353.3997.8597.273.40
2202178-20217898.39799.35
3207935-207935101.198102.17
4189708-18970892.32893.22
5191854-19185493.37294.24
6197008-19700895.88096.78
180min1199578-19957897.13196.193.3498.2097.253.35
2201278-20127897.95999.06
3207485-207485100.979102.10
4189346-18934692.15193.18
5191875-19187593.38294.40
6196278-19627895.52596.56
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1199717-19971797.19995.853.4898.4297.063.48
2199397-19939797.04398.29
3207492-207492100.983102.25
4188085-18808591.53892.70
5191569-19156993.23394.39
6195463-19546395.12996.31
360min1200503-20050397.58195.773.6098.9597.123.60
2199829-19982997.25398.64
3206933-206933100.711102.13
4187484-18748491.24592.55
5190882-19088292.89994.19
6195107-19510794.95596.28
480min1198226-19822696.47395.413.4297.9896.913.42
2198985-19898596.84398.38
3206034-206034100.273101.85
4187501-18750191.25492.69
5189935-18993592.43893.87
6195624-19562495.20796.67
600min1197806-19780696.26994.993.3197.9296.633.31
2198166-19816696.44498.13
3204666-20466699.607101.33
4187329-18732991.17092.75
5188921-18892191.94593.52
6194183-19418394.50696.12
720min1197420-19742096.08194.183.4597.8895.963.45
2194816-19481694.81496.64
3203408-20340898.995100.87
4185811-18581190.43192.14
5186617-18661790.82392.53
6192988-19298893.92495.68
极限1195998-19599895.38993.933.3997.3395.853.39
2194304-19430494.56496.53
3203213-20321398.900100.92
4185518-18551890.28892.14
5186527-18652790.78092.62
6192494-19249493.68495.58
达格列净二甲双胍缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100664-202106对照品来源中检院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10
标示量(mg)1000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%
19.359023838981058994418982958995918995630.20
29.379168309150189159240.14
单位质量响应值RSD%判断
96209.9597750.691.13数据可信
供试品溶液-WK2170批-二甲双胍-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%
5min134100-341003.5163.6610.403.523.6610.34
236891-368913.8043.80
336387-363873.7523.75
441743-417434.3054.30
531928-319283.2923.29
632089-320893.3093.31
10min180765-807658.3298.226.028.338.226.01
285602-856028.8278.83
381576-815768.4128.42
482444-824448.5028.51
573629-736297.5937.60
674129-741297.6447.65
15min1118768-11876812.24711.985.7112.2712.005.72
2123522-12352212.73812.76
3121053-12105312.48312.50
4117538-11753812.12112.14
5107724-10772411.10911.12
6108330-10833011.17111.19
20min1149649-14964915.43215.114.4315.4715.144.42
2154333-15433315.91515.95
3149707-14970715.43815.47
4148151-14815115.27715.31
5138130-13813014.24414.28
6139038-13903814.33814.37
30min1201625-20162520.79220.966.8820.8521.026.88
2206697-20669721.31521.38
3216165-21616522.29122.35
4220289-22028922.71622.78
5187132-18713219.29719.35
6187625-18762519.34819.40
45min1263856-26385627.20926.682.8327.3026.772.85
2266809-26680927.51327.61
3260536-26053626.86726.96
4261787-26178726.99627.09
5249998-24999825.78025.86
6249382-24938225.71625.80
60min1315598-31559832.54532.012.6632.6832.142.67
2321142-32114233.11633.25
3311172-31117232.08832.22
4313274-31327432.30532.44
5299844-29984430.92031.04
6301694-30169431.11131.23
120min1487865-48786550.30948.902.2750.4949.082.27
2485557-48555750.07150.26
3470223-47022348.48948.67
4475470-47547049.03149.21
5463360-46336047.78247.95
6463031-46303147.74847.92
180min1602086-60208662.08760.501.8962.3460.751.90
2597236-59723661.58761.85
3581673-58167359.98260.24
4587575-58757560.59160.85
5575004-57500459.29559.53
6576577-57657759.45759.70
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1683433-68343370.47669.161.1870.8269.501.19
2676768-67676869.78870.14
3667947-66794768.87969.22
4667765-66776568.86069.21
5661809-66180968.24668.57
6666521-66652168.73269.06
360min1810625-81062583.59281.891.3384.0582.331.33
2803594-80359482.86783.32
3790237-79023781.48981.94
4789104-78910481.37381.82
5786559-78655981.11081.54
6784473-78447380.89581.33
480min1882732-88273291.02889.950.9291.6190.520.93
2881905-88190590.94291.52
3865459-86545989.24689.82
4870852-87085289.80290.38
5867214-86721489.42789.98
6865665-86566589.26889.82
600min1935996-93599696.52094.491.2497.2495.191.24
2921681-92168195.04495.76
3909185-90918593.75594.46
4916636-91663694.52495.23
5907046-90704693.53594.22
6907189-90718993.55094.24
720min1958847-95884798.87796.291.4399.7497.141.42
2929166-92916695.81696.68
3928403-92840395.73796.58
4934418-93441896.35797.21
5919646-91964694.83495.66
6932199-93219996.12996.96
极限1953188-95318898.29396.231.1299.3097.221.12
2929427-92942795.84396.85
3926034-92603495.49396.48
4935769-93576996.49797.49
5926792-92679295.57196.54
6928105-92810595.70696.68
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