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)5补液体积(ml)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对照品水分(%)0对照品稀释倍数50
标示量(mg)1000供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.654294683429277942919954295202428496042919240.10
211.334260414426865142645320.14
单位质量响应值RSD%判断
444758.96376392.9411.78数据不可信!(响应值差异过大,请重新称样测定!)
长期6月-供试品溶液-YA0011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%
5min1157320-1573203.8583.1214.453.863.1214.45
2107926-1079262.6472.65
3141383-1413833.4683.47
4119352-1193522.9272.93
5116657-1166572.8612.86
6121077-1210772.9702.97
10min1305226-3052267.4866.857.347.516.877.39
2254873-2548736.2516.26
3299824-2998247.3537.37
4263673-2636736.4676.48
5267509-2675096.5616.58
6284693-2846936.9827.00
15min1468773-46877311.49710.327.0911.5510.377.08
2395609-3956099.7039.75
3434462-43446210.65610.71
4415438-41543810.18910.24
5385024-3850249.4439.49
6424270-42427010.40610.46
20min1566063-56606313.88313.074.9014.0013.174.92
2512919-51291912.58012.67
3548128-54812813.44313.55
4523571-52357112.84112.94
5496795-49679512.18412.28
6549504-54950413.47713.58
30min1760679-76067918.65617.843.9918.8418.014.02
2704166-70416617.27017.43
3746598-74659818.31118.49
4720642-72064217.67417.84
5685365-68536516.80916.96
6746875-74687518.31818.49
45min1998617-99861724.49223.842.8324.7724.102.86
2946575-94657523.21623.46
3989114-98911424.25924.53
4977438-97743823.97324.22
5930144-93014422.81323.05
6990818-99081824.30124.56
60min11199145-119914529.41029.001.9229.8129.371.95
21144724-114472428.07628.43
31187023-118702329.11329.50
41192447-119244729.24629.62
51166431-116643128.60828.96
61204544-120454429.54329.92
120min11814453-181445344.50144.591.8045.0545.111.81
21783945-178394543.75344.25
31838230-183823045.08445.62
41840293-184029345.13545.65
51775433-177543343.54444.04
61855697-185569745.51346.04
180min12294351-229435156.27156.171.2857.0456.921.28
22236782-223678254.85955.58
32284311-228431156.02556.78
42295252-229525256.29357.04
52312469-231246956.71657.43
62319217-231921756.88157.64
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12643605-264360564.83765.591.6865.8966.621.66
22643121-264312164.82565.82
32691217-269121766.00567.04
42730210-273021066.96167.98
52621293-262129364.29065.29
62717529-271752966.65067.69
360min13213706-321370678.81979.651.4480.1981.001.44
23206864-320686478.65279.97
33266955-326695580.12581.49
43303380-330338081.01982.38
53199345-319934578.46779.79
63295150-329515080.81782.19
480min13522934-352293486.40487.821.7688.1789.571.74
23550680-355068087.08488.79
33590557-359055788.06289.83
43695637-369563790.63992.40
53534519-353451986.68888.40
63590547-359054788.06289.84
600min13779184-377918492.68893.331.4594.8995.521.44
23748982-374898291.94894.09
33855410-385541094.55896.77
43890623-389062395.42297.64
53773661-377366192.55394.70
63784432-378443292.81795.04
720min13901452-390145295.68795.652.1198.3598.302.08
23797143-379714393.12995.73
33895141-389514195.53298.21
44046735-404673599.250101.94
53860991-386099194.69597.30
63898171-389817195.60798.29
极限13914776-391477696.01495.411.5399.1698.541.51
23868312-386831294.87497.94
33833334-383333494.01697.18
43997666-399766698.047101.24
53852500-385250094.48797.57
63874144-387414495.01798.18
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)5补液体积(ml)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12500
标示量(mg)1000供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.811640216209163661642216431163660.56
213.811633016218162740.49
单位质量响应值RSD%判断
1185.081178.420.40数据可信
长期6月-供试品溶液-YA0011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%
5min114093-140930.3840.3312.860.380.3312.40
210819-108190.2940.29
313396-133960.3650.36
411228-112280.3060.31
510261-102610.2790.28
612841-128410.3490.35
10min117968-179680.4890.492.230.490.492.77
217375-173750.4730.47
318314-183140.4980.50
418211-182110.4960.50
517986-179860.4890.49
618545-185450.5050.51
15min118938-189380.5150.523.230.520.523.10
218171-181710.4950.50
318320-183200.4990.50
418961-189610.5160.52
519766-197660.5380.54
619452-194520.5290.53
20min118776-187760.5110.522.000.520.522.25
218650-186500.5080.51
318525-185250.5040.51
419079-190790.5190.53
519595-195950.5330.54
618942-189420.5150.52
30min118844-188440.5130.523.020.520.532.60
218402-184020.5010.51
318678-186780.5080.52
419297-192970.5250.53
520009-200090.5450.55
619303-193030.5250.53
45min118769-187690.5110.522.400.520.532.50
218677-186770.5080.52
318777-187770.5110.52
419412-194120.5280.54
519834-198340.5400.55
619216-192160.5230.54
60min118718-187180.5090.523.200.520.543.50
218597-185970.5060.52
318792-187920.5110.53
419280-192800.5250.54
520235-202350.5510.57
619102-191020.5200.53
120min118642-186420.5070.522.770.520.542.55
218707-187070.5090.53
318928-189280.5150.53
419175-191750.5220.54
520047-200470.5460.56
619379-193790.5270.54
180min118542-185420.5050.523.620.520.543.88
218524-185240.5040.52
318351-183510.4990.52
420170-201700.5490.57
518906-189060.5150.53
619334-193340.5260.55
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min118447-184470.5020.523.240.520.543.61
218745-187450.5100.53
318320-183200.4990.52
419375-193750.5270.55
519957-199570.5430.57
619167-191670.5220.54
360min118383-183830.5000.523.090.530.543.01
218659-186590.5080.53
318529-185290.5040.53
419191-191910.5220.55
519903-199030.5420.57
619328-193280.5260.55
480min118228-182280.4960.513.480.520.543.32
218423-184230.5010.53
318372-183720.5000.53
419169-191690.5220.55
519936-199360.5430.57
618896-188960.5140.54
600min118286-182860.4980.513.130.530.542.87
218227-182270.4960.53
318304-183040.4980.53
418816-188160.5120.54
519774-197740.5380.57
618753-187530.5100.54
720min118238-182380.4960.513.780.530.543.59
217843-178430.4860.52
318219-182190.4960.53
419245-192450.5240.56
519682-196820.5360.57
618465-184650.5030.54
极限118181-181810.4950.503.360.530.543.20
218211-182110.4960.53
317879-178790.4870.52
418696-186960.5090.54
519650-196500.5350.57
618427-184270.5010.54
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)5补液体积(ml)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对照品水分(%)0对照品稀释倍数50
标示量(mg)1000供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.654283163428661742804264285134428295342836590.06
211.334310307430649543084010.07
单位质量响应值RSD%判断
443902.49380264.8710.92数据不可信!(响应值差异过大,请重新称样测定!)
长期6月-供试品溶液-YA0011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%
5min1142190-1421903.4713.118.443.473.128.46
2137891-1378913.3663.37
3115116-1151162.8102.81
4128014-1280143.1253.13
5124107-1241073.0303.03
6118027-1180272.8812.88
10min1307921-3079217.5176.945.077.536.965.04
2274065-2740656.6916.71
3278478-2784786.7986.81
4296084-2960847.2287.24
5271471-2714716.6276.64
6278247-2782476.7936.81
15min1430246-43024610.50310.361.0010.5610.411.01
2419698-41969810.24610.30
3421229-42122910.28310.33
4424435-42443510.36210.41
5421794-42179410.29710.35
6428471-42847110.46010.51
20min1548326-54832613.38613.242.5213.4913.342.51
2536041-53604113.08613.19
3540248-54024813.18913.29
4559062-55906213.64813.75
5519922-51992212.69312.79
6550510-55051013.43913.54
30min1743111-74311118.14118.011.5118.3218.181.52
2731319-73131917.85318.02
3743363-74336318.14718.31
4748009-74800918.26118.43
5718058-71805817.53017.69
6742176-74217618.11818.29
45min1987721-98772124.11324.140.7624.3824.400.77
2983185-98318524.00224.26
3987632-98763224.11124.37
41002166-100216624.46524.73
5981029-98102923.94924.20
6991704-99170424.21024.47
60min11205876-120587629.43829.060.8529.8229.430.85
21186033-118603328.95429.33
31179311-117931128.79029.17
41194831-119483129.16929.55
51181012-118101228.83129.20
61194259-119425929.15529.53
120min11832939-183293944.74744.870.5545.2845.400.54
21845436-184543645.05245.57
31854840-185484045.28145.80
41831557-183155744.71345.24
51834773-183477344.79145.31
61828854-182885444.64745.17
180min12243111-224311154.76055.430.8155.5256.180.79
22284744-228474455.77656.52
32294190-229419056.00756.75
42274402-227440255.52456.28
52260465-226046555.18455.92
62265546-226554655.30856.06
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12716871-271687166.32665.481.0167.3666.501.00
22702926-270292665.98567.01
32694350-269435065.77666.80
42647143-264714364.62365.66
52658674-265867464.90565.92
62672532-267253265.24366.27
360min13222442-322244278.66877.511.8480.0378.861.81
23206870-320687078.28879.64
33228576-322857678.81780.17
43130816-313081676.43177.79
53179831-317983177.62878.97
63080848-308084875.21176.56
480min13650701-365070189.12388.481.2390.8890.221.19
23584246-358424687.50089.25
33579083-357908387.37489.12
43607506-360750688.06889.81
53628032-362803288.56990.30
63695949-369594990.22791.95
600min13806546-380654692.92793.501.0395.1395.681.00
23823484-382348493.34195.52
33889726-388972694.95897.14
43844891-384489193.86396.04
53841937-384193793.79195.96
63773581-377358192.12294.30
720min13893483-389348395.05094.930.5297.7297.580.51
23872853-387285394.54697.20
33878739-387873994.69097.35
43869145-386914594.45597.10
53924177-392417795.79998.44
63893225-389322595.04397.68
极限13940827-394082796.20595.241.7099.3598.361.64
23883761-388376194.81297.94
33834965-383496593.62196.76
43844190-384419093.84696.97
53891176-389117694.99398.11
64011706-401170697.936101.05
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)5补液体积(ml)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12500
标示量(mg)1000供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.811634716184163541628316475163290.66
213.811653916489165140.22
单位质量响应值RSD%判断
1182.401195.800.80数据可信
长期6月-供试品溶液-YA0011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%
5min113212-132120.3570.348.620.360.348.96
213428-134280.3630.36
313010-130100.3520.35
412821-128210.3470.35
510475-104750.2830.28
612933-129330.3500.35
10min118069-180690.4890.502.400.490.502.53
218088-180880.4890.49
318788-187880.5080.51
417910-179100.4840.49
518306-183060.4950.50
619020-190200.5140.52
15min119180-191800.5190.522.910.520.522.55
218959-189590.5130.52
319089-190890.5160.52
418225-182250.4930.50
519390-193900.5240.53
619919-199190.5390.54
20min119361-193610.5240.522.780.530.533.04
219250-192500.5210.53
319290-192900.5220.53
418318-183180.4950.50
519476-194760.5270.53
619918-199180.5390.55
30min119419-194190.5250.521.840.530.531.54
219090-190900.5160.53
319557-195570.5290.54
418812-188120.5090.52
519639-196390.5310.54
619755-197550.5340.54
45min119516-195160.5280.532.480.540.542.18
219035-190350.5150.53
319398-193980.5250.54
418777-187770.5080.52
519933-199330.5390.55
620005-200050.5410.55
60min119737-197370.5340.523.090.550.543.05
218920-189200.5120.53
319200-192000.5190.53
418376-183760.4970.51
519866-198660.5370.55
619804-198040.5360.55
120min119376-193760.5240.522.490.540.542.52
219177-191770.5190.54
319678-196780.5320.55
418530-185300.5010.52
519898-198980.5380.56
619605-196050.5300.55
180min119557-195570.5290.512.520.550.542.58
218744-187440.5070.53
319119-191190.5170.54
418227-182270.4930.51
519378-193780.5240.54
619169-191690.5180.54
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min119167-191670.5180.522.630.540.542.87
219148-191480.5180.54
319506-195060.5280.55
418209-182090.4920.51
519528-195280.5280.55
619399-193990.5250.55
360min119047-190470.5150.512.770.540.532.39
218707-187070.5060.53
319003-190030.5140.54
417815-178150.4820.51
519209-192090.5200.54
618395-183950.4980.52
480min119357-193570.5240.523.210.550.552.93
218622-186220.5040.53
319170-191700.5180.55
418458-184580.4990.53
519657-196570.5320.56
620070-200700.5430.57
600min118840-188400.5100.512.440.540.542.79
218787-187870.5080.54
319426-194260.5250.56
418305-183050.4950.52
519570-195700.5290.56
619207-192070.5190.55
720min118852-188520.5100.512.830.540.542.98
218207-182070.4920.52
318683-186830.5050.54
417957-179570.4860.52
519349-193490.5230.56
619111-191110.5170.55
极限118801-188010.5090.503.430.540.543.20
218280-182800.4940.53
318531-185310.5010.54
417658-176580.4780.51
519148-191480.5180.55
619456-194560.5260.56
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