达格列净片项目信息
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1000
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%
112.602130162130342119852130642128862127970.22
212.662089272112872101070.80
单位质量响应值RSD%判断
16888.6516596.131.24数据可信
供试品溶液-1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%
5min1151031-15103172.53371.222.4272.5371.222.42
2147075-14707570.63370.63
3144162-14416269.23469.23
4146159-14615970.19470.19
5147364-14736470.77270.77
6153991-15399173.95573.95
10min1163995-16399578.75978.281.8978.8778.381.89
2162862-16286278.21578.32
3159158-15915876.43676.54
4161403-16140377.51577.62
5162206-16220677.90078.01
6168304-16830480.82980.94
15min1170045-17004581.66581.281.7381.8981.501.73
2169262-16926281.28981.51
3165681-16568179.56979.79
4167865-16786580.61880.84
5168210-16821080.78481.01
6174371-17437183.74383.97
20min1174873-17487383.98483.061.7784.3383.401.77
2173404-17340483.27883.62
3168535-16853580.94081.28
4172524-17252482.85583.20
5170995-17099582.12182.47
6177317-17731785.15785.52
30min1177830-17783085.40484.702.0285.8885.172.01
2176330-17633084.68385.15
3172214-17221482.70783.17
4175563-17556384.31584.78
5173871-17387183.50283.97
6182419-18241987.60888.09
45min1180711-18071186.78786.352.1087.3986.952.10
2180351-18035186.61487.21
3175505-17550584.28784.87
4178205-17820585.58486.18
5177622-17762285.30485.90
6186449-18644989.54390.16
极限1204154-20415498.04696.791.1898.7897.521.18
2202427-20242797.21797.94
3201198-20119896.62697.34
4201053-20105396.55797.28
5197339-19733994.77395.49
6203044-20304497.51398.26
达格列净片项目信息
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1000
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%
112.602103082102352104212102162097822101920.12
212.662122082101572111820.69
单位质量响应值RSD%判断
16681.9016681.040.01数据可信
供试品溶液-1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%
5min1149758-14975872.17971.311.5272.1871.311.52
2148909-14890971.77071.77
3147488-14748871.08571.09
4149367-14936771.99171.99
5148569-14856971.60671.61
6143663-14366369.24269.24
10min1166174-16617480.09179.540.8780.2079.650.87
2166309-16630980.15680.26
3164687-16468779.37479.48
4166310-16631080.15780.26
5163410-16341078.75978.87
6163325-16332578.71878.82
15min1172561-17256183.17082.550.8483.4082.770.85
2173064-17306483.41283.64
3170661-17066182.25482.48
4171817-17181782.81183.04
5170003-17000381.93782.16
6169492-16949281.69081.91
20min1174989-17498984.34084.060.5584.6984.410.55
2174807-17480784.25284.61
3174811-17481184.25484.60
4175310-17531084.49484.85
5172810-17281083.29083.64
6173745-17374583.74084.08
30min1177318-17731885.46285.690.7685.9486.170.76
2178442-17844286.00486.48
3176425-17642585.03285.51
4180171-18017186.83787.32
5177486-17748685.54386.02
6176960-17696085.29085.76
45min1181845-18184587.64487.850.9288.2588.450.92
2181575-18157587.51488.12
3180932-18093287.20487.81
4185206-18520689.26489.87
5183221-18322188.30788.91
6180847-18084787.16387.76
极限1197673-19767395.27396.551.1896.0197.281.17
2198042-19804295.45196.19
3200116-20011696.45097.18
4202077-20207797.39598.14
5203811-20381198.23198.97
6200200-20020096.49197.22
达格列净片项目信息
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1000
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%
112.602083432074732084142089352086932083720.27
212.662081292088002084640.23
单位质量响应值RSD%判断
16537.4616466.350.31数据可信
供试品溶液-1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%
5min1150941-15094173.54173.292.3973.5473.292.39
2143998-14399870.15970.16
3152742-15274274.41974.42
4151760-15176073.94073.94
5154149-15414975.10475.10
6149012-14901272.60172.60
10min1164983-16498380.38381.562.7780.4981.672.76
2161490-16149078.68178.79
3174379-17437984.96185.07
4169924-16992482.79082.90
5169108-16910882.39382.51
6164551-16455180.17280.28
15min1170522-17052283.08285.193.5583.3185.423.54
2166803-16680381.27081.49
3183248-18324889.28289.52
4179915-17991587.65887.89
5176695-17669586.08986.33
6171891-17189183.74983.98
20min1174478-17447885.00987.253.1885.3687.613.18
2174295-17429584.92085.26
3187008-18700891.11491.49
4184545-18454589.91490.28
5179920-17992087.66088.03
6174177-17417784.86285.22
30min1175732-17573285.62089.323.1886.1089.813.18
2180512-18051287.94988.42
3189801-18980192.47592.98
4190107-19010792.62493.13
5184303-18430389.79690.29
6179463-17946387.43887.92
45min1178539-17853986.98890.502.9587.6091.122.95
2184311-18431189.80090.40
3192713-19271393.89394.54
4191271-19127193.19193.83
5185939-18593990.59391.22
6181676-18167688.51689.13
极限1194470-19447094.74996.791.1595.4997.551.16
2198138-19813896.53797.28
3200334-20033497.60698.40
4199335-19933597.12097.90
5200888-20088897.87698.64
6198809-19880996.86397.61
达格列净片项目信息
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1000
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%
112.602093222093642079842083842075412085190.39
212.662115302124382119840.31
单位质量响应值RSD%判断
16549.1316744.390.83数据可信
供试品溶液-1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%
5min1158869-15886976.73374.142.0176.7374.142.01
2153188-15318873.98973.99
3154680-15468074.70974.71
4150431-15043172.65772.66
5150741-15074172.80772.81
6153065-15306573.92973.93
10min1179413-17941386.65585.072.8386.7785.182.82
2178989-17898986.45186.56
3178883-17888386.39986.51
4172772-17277283.44883.56
5167440-16744080.87280.98
6179304-17930486.60386.71
15min1187722-18772290.66989.072.9790.9189.312.97
2187674-18767490.64590.89
3187683-18768390.65090.89
4179942-17994286.91187.14
5175302-17530284.67084.90
6188202-18820290.90091.14
20min1191997-19199792.73390.753.1093.1191.123.10
2192901-19290193.17093.55
3188231-18823190.91491.29
4184205-18420588.97089.33
5178050-17805085.99786.35
6191957-19195792.71493.09
30min1193470-19347093.44592.532.7993.9693.042.79
2195863-19586394.60195.12
3191583-19158392.53393.05
4190781-19078192.14692.64
5181595-18159587.70988.20
6196111-19611194.72095.24
45min1195908-19590894.62294.192.6995.2894.832.69
2197819-19781995.54596.20
3196868-19686895.08695.74
4195315-19531594.33694.97
5184725-18472589.22189.84
6199402-19940296.31096.97
极限1202341-20234197.72998.430.5898.5399.220.56
2204125-20412598.59199.39
3203943-20394398.50399.30
4203329-20332998.20798.98
5205807-20580799.403100.16
6203230-20323098.15998.96
达格列净片项目信息
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1000
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%
112.602111872116092118962114482123572116990.22
212.662109622119332114480.33
单位质量响应值RSD%判断
16801.5116702.050.42数据可信
供试品溶液-1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%
5min1149849-14984971.92172.262.4771.9272.252.46
2148738-14873871.38771.39
3147034-14703470.56970.57
4156796-15679675.25575.25
5147837-14783770.95570.95
6153021-15302173.44373.44
10min1170262-17026281.71882.542.8981.8382.652.89
2173242-17324283.14883.26
3166494-16649479.90980.02
4178308-17830885.57985.69
5166876-16687680.09380.20
6176705-17670584.81084.92
15min1179431-17943186.11886.223.1486.3586.453.13
2182559-18255987.62087.85
3174256-17425683.63583.86
4184918-18491888.75288.99
5171646-17164682.38282.61
6185032-18503288.80789.04
20min1183268-18326887.96088.463.1288.3288.823.12
2188672-18867290.55490.92
3182663-18266387.67088.02
4189027-18902790.72491.10
5174063-17406383.54283.89
6188126-18812690.29290.66
30min1188145-18814590.30190.173.1190.7990.673.10
2191926-19192692.11592.61
3185830-18583089.19089.67
4192559-19255992.41992.93
5177226-17722685.06085.54
6191589-19158991.95492.46
45min1193628-19362892.93291.783.1393.5692.413.13
2195776-19577693.96394.60
3189327-18932790.86891.48
4195312-19531293.74194.39
5179946-17994686.36686.97
6193375-19337592.81193.45
极限1195168-19516893.67295.391.9194.4496.161.91
2200042-20004296.01196.79
3200924-20092496.43497.19
4204575-20457598.18698.98
5194894-19489493.54094.27
6196898-19689894.50295.29
达格列净片项目信息
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1000
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%
112.602126002123782124922125592133952126850.20
212.662139992150032145010.34
单位质量响应值RSD%判断
16879.7616943.210.27数据可信
供试品溶液-1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%
5min1150971-15097171.77471.621.9271.7771.621.91
2147471-14747170.11070.11
3149013-14901370.84370.84
4149572-14957271.10971.11
5155866-15586674.10274.10
6150995-15099571.78671.79
10min1166431-16643179.12479.611.4679.2379.721.46
2169132-16913280.40880.51
3166388-16638879.10479.21
4163553-16355377.75677.86
5169848-16984880.74980.86
6169426-16942680.54880.66
15min1173504-17350482.48783.381.6982.7183.601.69
2180427-18042785.77886.00
3174715-17471583.06383.29
4171725-17172581.64181.86
5176267-17626783.80184.03
6175599-17559983.48383.71
20min1177182-17718284.23684.951.9984.5985.301.99
2184745-18474587.83188.19
3178332-17833284.78285.13
4173832-17383282.64382.99
5178747-17874784.98085.34
6179225-17922585.20785.56
30min1182655-18265586.83887.391.8287.3187.871.81
2189886-18988690.27590.76
3182651-18265186.83687.31
4179811-17981185.48585.96
5183852-18385287.40787.89
6184049-18404987.50087.98
45min1186100-18610088.47588.752.2789.0889.362.26
2193999-19399992.23192.85
3186205-18620588.52589.13
4180818-18081885.96486.56
5185864-18586488.36388.98
6187115-18711588.95889.57
极限1200470-20047095.30795.760.9896.0596.500.97
2201205-20120595.65796.42
3205087-20508797.50298.24
4199285-19928594.74495.47
5201615-20161595.85196.60
6200872-20087295.49896.24
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