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%
112.651643931644681645851646861646901645640.09
212.621656851657321657080.03
单位质量响应值RSD%判断
13009.0113130.590.66数据可信
供试品溶液-WK2170批-达格列净-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%
5min1132046-13204664.98560.9111.0564.9860.9111.05
2118557-11855758.34658.35
3123194-12319460.62860.63
4130480-13048064.21464.21
5138567-13856768.19468.19
699798-9979849.11449.11
10min1183545-18354590.32986.443.1590.4386.533.15
2167494-16749482.43082.52
3171954-17195484.62584.72
4176664-17666486.94387.04
5178641-17864187.91688.02
6175519-17551986.37986.45
15min1190470-19047093.73789.752.7493.9789.972.74
2175888-17588886.56186.77
3179292-17929288.23688.45
4181172-18117289.16289.39
5182577-18257789.85390.09
6184804-18480490.94991.15
20min1191787-19178794.38690.772.5794.7691.132.57
2178900-17890088.04388.38
3181450-18145089.29889.65
4182216-18221689.67590.04
5184237-18423790.67091.04
6188056-18805692.54992.89
30min1192719-19271994.84491.692.3595.3692.182.35
2182376-18237689.75490.23
3183482-18348290.29890.78
4183106-18310690.11390.61
5185397-18539791.24191.75
6190780-19078093.89094.37
45min1193138-19313895.05092.332.1595.7192.962.14
2183982-18398290.54491.15
3184020-18402090.56391.18
4186396-18639691.73292.36
5186039-18603991.55792.20
6192108-19210894.54495.16
60min1192715-19271594.84292.562.0295.6493.332.01
2184693-18469390.89491.64
3184586-18458690.84291.60
4188076-18807692.55993.33
5185737-18573791.40892.19
6192658-19265894.81495.58
120min1198591-19859197.73495.082.4398.6895.992.42
2190511-19051193.75894.64
3190225-19022593.61794.51
4188502-18850292.76993.68
5191782-19178294.38395.30
6199558-19955898.21099.11
180min1197813-19781397.35194.942.3598.4495.992.34
2191076-19107694.03695.06
3190466-19046693.73594.77
4188070-18807092.55693.60
5190774-19077493.88794.94
6199305-19930598.08599.14
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1197680-19768097.28694.832.3098.5296.022.29
2190824-19082493.91295.07
3190410-19041093.70894.88
4187760-18776092.40493.59
5190807-19080793.90395.10
6198707-19870797.79198.99
360min1196921-19692196.91294.482.3398.2995.822.32
2190085-19008593.54894.85
3189295-18929593.15994.47
4187527-18752792.28993.61
5189786-18978693.40194.74
6198286-19828697.58498.93
480min1195992-19599296.45594.172.3097.9895.652.29
2189551-18955193.28594.73
3188907-18890792.96894.42
4186860-18686091.96193.42
5189096-18909693.06194.54
6197742-19774297.31698.81
600min1195181-19518196.05693.682.2997.7395.302.27
2188963-18896392.99694.58
3187717-18771792.38393.98
4185768-18576891.42393.02
5188174-18817492.60794.23
6196371-19637196.64298.28
720min1194878-19487895.90793.282.4097.7295.042.38
2187495-18749592.27394.00
3186645-18664591.85593.59
4184093-18409390.59992.34
5188957-18895792.99394.75
6195177-19517796.05497.84
极限1194159-19415995.55392.942.4897.5194.842.47
2187080-18708092.06993.93
3186454-18645491.76193.63
4183715-18371590.41392.29
5186503-18650391.78593.68
6195228-19522896.07998.00
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%
19.359061989087909109139128399125259102530.31
29.379193629202189197900.07
单位质量响应值RSD%判断
97353.2698163.290.59数据可信
供试品溶液-WK2170批-二甲双胍-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%
5min133388-333883.4153.365.743.423.365.74
232850-328503.3603.36
331960-319603.2693.27
434475-344753.5273.53
534736-347363.5533.55
629616-296163.0303.03
10min180522-805228.2377.836.158.247.836.14
272409-724097.4077.41
375788-757887.7537.76
479870-798708.1708.18
580801-808018.2668.27
669632-696327.1237.13
15min1131482-13148213.45011.798.8813.4711.818.87
2108050-10805011.05311.07
3112966-11296611.55611.57
4117998-11799812.07112.09
5119198-11919812.19312.21
6101869-10186910.42110.44
20min1151058-15105815.45214.775.4015.4914.815.41
2137595-13759514.07514.11
3143929-14392914.72314.76
4149780-14978015.32215.36
5151361-15136115.48315.52
6132770-13277013.58213.61
30min1203269-20326920.79320.004.4720.8520.064.47
2187667-18766719.19719.25
3194189-19418919.86519.92
4201903-20190320.65420.71
5203217-20321720.78820.85
6182960-18296018.71618.77
45min1265602-26560227.17026.675.5527.2626.765.54
2248575-24857525.42825.51
3254781-25478126.06326.15
4284112-28411229.06329.15
5266495-26649527.26127.35
6244674-24467425.02925.11
60min1316835-31683532.41131.763.7132.5431.883.72
2299650-29965030.65330.77
3306028-30602831.30531.43
4325348-32534833.28133.41
5318460-31846032.57732.71
6296376-29637630.31830.43
120min1485632-48563249.67848.782.3549.8648.952.35
2466594-46659447.73047.90
3469381-46938148.01548.19
4484580-48458049.57049.75
5490144-49014450.13950.32
6464675-46467547.53447.70
180min1600648-60064861.44360.631.8061.7060.881.80
2583038-58303859.64259.88
3586113-58611359.95660.20
4599544-59954461.33061.59
5606015-60601561.99262.25
6580907-58090759.42459.66
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1689611-68961170.54469.861.4070.8970.201.41
2677694-67769469.32569.65
3676176-67617669.16969.50
4688679-68867970.44870.80
5694965-69496571.09171.44
6670394-67039468.57868.90
360min1815182-81518283.38982.861.0883.8483.311.09
2802143-80214382.05582.49
3802335-80233582.07582.51
4816810-81681083.55584.01
5821360-82136084.02184.48
6802413-80241382.08382.51
480min1896947-89694791.75391.460.8492.3392.030.85
2887336-88733690.77091.32
3886404-88640490.67591.24
4902681-90268192.34092.92
5902393-90239392.31092.89
6888968-88896890.93791.49
600min1943798-94379896.54696.360.6897.2697.060.69
2936645-93664595.81496.51
3934828-93482895.62896.32
4948636-94863697.04197.76
5949812-94981297.16197.88
6938127-93812795.96696.65
720min1968363-96836399.05998.860.6999.9299.710.69
2960839-96083998.28999.12
3958654-95865498.06598.91
4973554-97355499.590100.45
5974056-97405699.641100.51
6962999-96299998.51099.34
极限1966783-96678398.89798.840.5499.9199.830.55
2960568-96056898.26199.24
3960673-96067398.27299.26
4971390-97139099.368100.38
5972700-97270099.502100.52
6965013-96501398.71699.69
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%
112.651682991679671682911681101678221680980.13
212.621694161694691694420.03
单位质量响应值RSD%判断
13288.3813426.470.74数据可信
供试品溶液-WK2170批-达格列净-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%
5min1134084-13408464.56759.9610.8464.5759.9610.84
299025-9902547.68547.68
3125610-12561060.48760.49
4124636-12463660.01860.02
5137309-13730966.12066.12
6126480-12648060.90660.91
10min1176908-17690885.18982.305.1785.2982.395.17
2162112-16211278.06478.14
3162982-16298278.48378.57
4164374-16437479.15379.24
5176224-17622484.85984.96
6182832-18283288.04188.13
15min1182454-18245487.85986.553.6988.0886.763.70
2173516-17351683.55583.74
3173406-17340683.50283.71
4175138-17513884.33684.55
5184820-18482088.99989.23
6189039-18903991.03091.25
20min1183718-18371888.46888.053.4488.8288.393.45
2177566-17756685.50685.82
3176755-17675585.11585.45
4179026-17902686.20986.54
5187382-18738290.23290.59
6192673-19267392.78093.14
30min1183991-18399188.60089.112.8989.0989.582.90
2181292-18129287.30087.74
3179278-17927886.33086.79
4183202-18320288.22088.68
5188562-18856290.80191.30
6193918-19391893.38093.88
45min1184942-18494289.05889.892.4489.6890.502.45
2183639-18363988.43089.00
3181671-18167187.48288.07
4186229-18622989.67790.27
5189130-18913091.07491.71
6194414-19441493.61994.26
60min1185473-18547389.31390.262.4190.0791.002.41
2184354-18435488.77489.48
3182016-18201687.64988.37
4188701-18870190.86891.60
5189327-18932791.16991.94
6194746-19474693.77994.56
120min1190994-19099491.97292.972.3592.8693.852.35
2191208-19120892.07592.91
3187756-18775690.41391.27
4192118-19211892.51393.38
5195576-19557694.17895.08
6200752-20075296.67197.59
180min1189753-18975391.37492.722.4092.4093.742.41
2190767-19076791.86292.84
3187569-18756990.32391.31
4191720-19172092.32193.33
5194850-19485093.82994.87
6200589-20058996.59297.66
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1190008-19000891.49792.712.3692.6693.872.37
2190397-19039791.68492.80
3187640-18764090.35791.48
4191846-19184692.38293.53
5194897-19489793.85195.04
6200391-20039196.49797.71
360min1188819-18881990.92492.542.3592.2393.842.35
2190694-19069491.82793.08
3187050-18705090.07391.33
4192921-19292192.90094.18
5193725-19372593.28794.61
6199852-19985296.23797.59
480min1187995-18799590.52891.992.2491.9793.422.24
2189898-18989891.44492.83
3186177-18617789.65291.05
4190664-19066491.81393.24
5193184-19318493.02694.49
6198247-19824795.46496.96
600min1186822-18682289.96391.552.3891.5493.122.39
2188705-18870590.87092.40
3185277-18527789.21990.75
4189558-18955891.28092.84
5192387-19238792.64394.25
6197899-19789995.29796.94
720min1186444-18644489.78191.052.3191.4992.762.31
2187477-18747790.27891.94
3183951-18395188.58090.24
4188886-18888690.95792.65
5191284-19128492.11193.86
6196419-19641994.58496.37
极限1185823-18582389.48290.752.3291.3392.592.32
2187275-18727590.18191.98
3183521-18352188.37390.17
4187732-18773290.40192.23
5190219-19021991.59993.48
6196113-19611394.43796.36
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%
19.359300959288279291249288269267229287190.14
29.379230399225399227890.04
单位质量响应值RSD%判断
99328.2498483.350.61数据可信
供试品溶液-WK2170批-二甲双胍-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%
5min130645-306453.0983.4313.303.103.4313.29
242212-422124.2684.27
334189-341893.4573.46
433387-333873.3763.38
533847-338473.4223.42
629245-292452.9572.96
10min176814-768147.7677.562.767.777.572.74
272469-724697.3277.33
375432-754327.6277.63
477431-774317.8297.83
573331-733317.4147.42
673330-733307.4147.42
15min1112209-11220911.34511.331.1211.3611.341.13
2111531-11153111.27711.29
3112609-11260911.38611.40
4114134-11413411.54011.56
5110722-11072211.19511.21
6111010-11101011.22411.24
20min1142667-14266714.42514.552.4914.4614.582.49
2139630-13963014.11814.15
3144050-14405014.56514.60
4145159-14515914.67714.71
5141828-14182814.34014.37
6150085-15008515.17515.21
30min1192729-19272919.48619.480.7519.5419.540.74
2191499-19149919.36219.42
3190994-19099419.31119.37
4194914-19491419.70719.76
5192451-19245119.45819.51
6193675-19367519.58219.64
45min1253469-25346925.62825.720.7325.7125.800.74
2254857-25485725.76825.85
3251500-25150025.42925.51
4257179-25717926.00326.09
5254439-25443925.72625.81
6254608-25460825.74325.83
60min1304336-30433630.77130.940.9730.8931.060.97
2307024-30702431.04331.17
3302120-30212030.54730.67
4310924-31092431.43731.56
5305518-30551830.89031.01
6305955-30595530.93531.06
120min1467831-46783147.30247.670.8747.4747.840.87
2476302-47630248.15848.33
3465436-46543647.05947.23
4472425-47242547.76647.94
5474404-47440447.96648.13
6472172-47217247.74047.91
180min1579528-57952858.59559.210.9358.8359.450.93
2592133-59213359.86960.11
3578375-57837558.47858.72
4587335-58733559.38459.63
5587934-58793459.44559.69
6588086-58808659.46059.70
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1667702-66770267.51068.300.8567.8468.630.84
2681454-68145468.90169.23
3669140-66914067.65667.98
4678254-67825468.57768.91
5679015-67901568.65468.98
6677644-67764468.51568.85
360min1793983-79398380.27881.351.0080.7181.781.00
2814483-81448382.35182.79
3796242-79624280.50780.93
4810218-81021881.92082.36
5806152-80615281.50981.94
6806469-80646981.54181.97
480min1875329-87532988.50389.600.9789.0590.150.97
2898329-89832990.82891.39
3877856-87785688.75889.31
4891325-89132590.12090.68
5888399-88839989.82490.38
6885605-88560589.54290.10
600min1920791-92079193.09994.621.0693.7895.311.06
2949703-94970396.02396.72
3930232-93023294.05494.74
4940651-94065195.10795.80
5939196-93919694.96095.65
6934345-93434594.47095.16
720min1947719-94771995.82297.130.9896.6497.960.98
2973750-97375098.45499.29
3954784-95478496.53697.36
4967565-96756597.82998.66
5963205-96320597.38898.22
6957068-95706896.76797.60
极限1948695-94869595.92197.241.0496.8998.221.04
2977619-97761998.84599.83
3955596-95559696.61997.59
4966679-96667997.73998.72
5963380-96338097.40698.38
6958617-95861796.92497.90
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