依折麦布贝派度酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DSMF-387-240606对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数2000
标示量(mg)10供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.159774649778239779039781129774999777600.03
211.179738689747769743220.07
单位质量响应值RSD%判断
87691.4887226.680.38数据可信
供试品溶液-2024092721批-依折麦布-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%
5min153543-535435.4965.278.535.505.278.57
254440-544405.5885.59
352819-528195.4225.42
444463-444634.5644.56
555299-552995.6765.68
647312-473124.8574.86
10min170874-708747.2757.313.417.347.373.45
273990-739907.5957.66
373956-739567.5917.65
468313-683137.0127.06
571303-713037.3197.38
668844-688447.0677.12
15min174197-741977.6167.662.967.767.803.01
276594-765947.8628.01
375567-755677.7577.90
471626-716267.3527.48
577082-770827.9128.06
672545-725457.4477.58
20min174528-745287.6508.149.517.888.379.32
276712-767127.8748.11
394054-940549.6559.89
475224-752247.7227.93
580467-804678.2608.49
674954-749547.6947.91
30min175573-755737.7578.4913.378.078.8013.00
279384-793848.1498.47
3104888-10488810.76711.10
477064-770647.9118.21
581260-812608.3418.67
677946-779468.0018.30
45min179726-797268.1849.4114.088.589.8213.72
283809-838098.6039.01
3116224-11622411.93012.39
493087-930879.5559.94
590227-902279.2629.68
687051-870518.9369.33
60min189998-899989.23811.8021.609.7312.3220.84
290424-904249.2829.79
3133571-13357113.71114.30
499845-9984510.24910.74
5148502-14850215.24415.76
6127475-12747513.08513.57
极限1124695-12469512.80016.0923.4913.3916.7322.79
2137149-13714914.07814.69
3159279-15927916.35017.09
4126279-12627912.96213.57
5221674-22167422.75523.44
6171197-17119717.57318.21
依折麦布贝派度酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号BEMA-231010D对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数100
标示量(mg)180供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.162607262610112605572617622607652609640.19
210.192596342593672595000.08
单位质量响应值RSD%判断
25685.4325466.140.61数据可信
供试品溶液-2024092721批-贝派度酸-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%
5min198035-9803538.22534.1017.0938.2234.1017.09
281807-8180731.89731.90
391935-9193535.84635.85
463769-6376924.86424.86
5106611-10661141.56841.57
682536-8253632.18132.18
10min1202333-20233378.89174.728.5679.3275.108.61
2184873-18487372.08372.44
3198295-19829577.31777.71
4165098-16509864.37364.65
5212025-21202582.67083.13
6187130-18713072.96373.32
15min1231584-23158490.29689.545.7491.6090.755.80
2228059-22805988.92290.08
3225058-22505887.75289.01
4211162-21116282.33483.33
5251986-25198698.25199.63
6230005-23000589.68190.85
20min1240118-24011893.62493.022.1795.9395.222.29
2239143-23914393.24495.39
3235330-23533091.75793.99
4230393-23039389.83291.74
5245438-24543895.69898.17
6240936-24093693.94396.11
30min1241995-24199594.35695.052.3597.7098.292.45
2245075-24507595.55798.74
3240067-24006793.60496.86
4236827-23682792.34195.25
5253517-25351798.848102.38
6245209-24520995.60998.82
45min1239973-23997393.56795.081.3697.9699.371.37
2245296-24529695.64399.88
3239806-23980693.50297.79
4244812-24481295.45499.38
5248220-24822096.783101.42
6245024-24502495.53799.81
60min1238251-23825192.89694.231.2498.3399.581.27
2241818-24181894.28799.59
3238553-23855393.01498.34
4241370-24137094.11299.10
5245447-24544795.702101.41
6244574-24457495.361100.69
极限1240693-24069393.84894.011.45100.31100.411.28
2239993-23999393.57599.93
3236708-23670892.29498.66
4247310-24731096.428102.46
5241929-24192994.330101.10
6240093-24009393.614100.01
依折麦布贝派度酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DSMF-387-240606对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数2000
标示量(mg)10供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.159758929757709746609758249740679752430.09
211.179707119704229705660.03
单位质量响应值RSD%判断
87465.7486890.420.47数据可信
供试品溶液-2024092721批-依折麦布-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%
5min145712-457124.7075.1515.104.715.1515.08
248061-480614.9494.95
358698-586986.0456.04
438471-384713.9623.96
557102-571025.8805.88
651814-518145.3365.34
10min169994-699947.2087.726.327.267.786.40
276786-767867.9077.96
379753-797538.2138.28
468565-685657.0617.10
579452-794528.1828.25
675250-752507.7497.81
15min177138-771387.9448.102.378.088.242.48
280653-806538.3068.45
379267-792678.1638.32
475851-758517.8117.93
580336-803368.2738.43
678706-787068.1058.25
20min178346-783468.0688.161.228.298.391.35
279609-796098.1988.43
379636-796368.2018.45
478004-780048.0338.24
580638-806388.3048.55
678953-789538.1318.37
30min179679-796798.2058.140.768.528.460.74
279347-793478.1718.50
378868-788688.1228.46
478938-789388.1298.43
579388-793888.1758.52
677975-779758.0308.36
45min180191-801918.2588.071.638.668.481.45
278438-784388.0788.49
377554-775547.9878.42
479043-790438.1408.53
578388-783888.0728.50
676445-764457.8728.29
60min177938-779388.0267.911.438.528.411.33
277017-770177.9318.44
376530-765307.8818.40
477428-774287.9748.45
577223-772237.9528.47
674793-747937.7028.20
极限177966-779668.0297.892.168.618.481.98
277226-772267.9538.55
375513-755137.7768.38
477890-778908.0218.59
577189-771897.9498.56
673757-737577.5958.18
依折麦布贝派度酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号BEMA-231010D对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数100
标示量(mg)180供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.162603152602082596832600862599872600560.10
210.192592312587782590040.13
单位质量响应值RSD%判断
25596.0625417.470.50数据可信
供试品溶液-2024092721批-贝派度酸-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%
5min14977-49771.9462.7428.791.952.7428.71
27114-71142.7812.78
39361-93613.6603.66
44339-43391.6961.70
58850-88503.4603.46
67446-74462.9112.91
10min112997-129975.0815.689.775.105.729.87
214591-145915.7045.74
316174-161746.3236.36
412681-126814.9584.98
515646-156466.1176.16
615127-151275.9145.95
15min116252-162526.3546.574.276.436.664.42
217075-170756.6766.77
317052-170526.6676.78
415616-156166.1056.18
517520-175206.8506.96
617248-172486.7436.84
20min117218-172186.7326.851.966.887.012.18
217708-177086.9237.09
317640-176406.8977.08
416961-169616.6316.77
517837-178376.9747.16
617706-177066.9227.10
30min117760-177606.9436.961.467.177.211.42
218003-180037.0387.28
317364-173646.7897.05
417751-177516.9407.16
518109-181097.0807.34
617868-178686.9867.24
45min117921-179217.0067.071.797.317.401.60
217942-179427.0157.34
318017-180177.0447.38
418684-186847.3057.60
518220-182207.1237.46
617781-177816.9527.28
60min117822-178226.9687.111.457.357.511.54
218420-184207.2017.60
318312-183127.1597.57
417934-179347.0117.39
518459-184597.2177.63
618246-182467.1337.54
极限118150-181507.0967.130.757.557.600.85
218059-180597.0607.54
318217-182177.1227.62
418160-181607.1007.55
518328-183287.1667.66
618435-184357.2077.69
依折麦布贝派度酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DSMF-387-240606对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数2000
标示量(mg)10供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.159776319777669772829777399774529775740.03
211.179679409678399678900.01
单位质量响应值RSD%判断
87674.8086650.850.84数据可信
供试品溶液-2024092721批-依折麦布-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%
5min147219-472194.8645.2813.404.865.2813.40
251455-514555.3005.30
357698-576985.9435.94
454500-545005.6145.61
556873-568735.8585.86
639613-396134.0804.08
10min172583-725837.4767.715.797.537.775.86
277326-773267.9658.02
379262-792628.1648.23
475545-755457.7817.84
577127-771277.9448.01
667274-672746.9296.97
15min178894-788948.1268.172.768.268.322.84
281106-811068.3548.50
381931-819318.4398.60
478859-788598.1238.27
579663-796638.2058.36
675665-756657.7947.92
20min178591-785918.0958.221.528.328.461.64
281012-810128.3448.58
381327-813278.3778.63
479356-793568.1748.41
580198-801988.2608.50
678488-784888.0848.29
30min178752-787528.1118.101.508.438.421.41
279493-794938.1888.52
378775-787758.1148.46
476447-764477.8748.20
578339-783398.0698.41
679773-797738.2178.52
45min177728-777288.0068.051.628.418.461.50
278918-789188.1298.55
378687-786878.1058.54
476445-764457.8748.29
577103-771037.9428.37
679867-798678.2268.62
60min176841-768417.9157.941.788.418.441.62
278320-783208.0678.58
377551-775517.9888.51
475153-751537.7418.25
575859-758597.8148.33
678602-786028.0968.58
极限175743-757437.8027.851.968.398.441.80
278241-782418.0598.66
375166-751667.7428.35
474151-741517.6388.23
576502-765027.8808.48
677382-773827.9708.54
依折麦布贝派度酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号BEMA-231010D对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数100
标示量(mg)180供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.162603982603982603132604032606242604270.05
210.192580912582552581730.05
单位质量响应值RSD%判断
25632.5825335.920.83数据可信
供试品溶液-2024092721批-贝派度酸-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%
5min16234-62342.4393.1223.212.443.1223.24
28055-80553.1523.15
39750-97503.8153.82
48994-89943.5193.52
59595-95953.7553.75
65272-52722.0632.06
10min114123-141235.5275.888.415.555.918.53
214990-149905.8665.90
315812-158126.1876.23
415626-156266.1156.15
516552-165526.4776.52
613063-130635.1125.13
15min116537-165376.4716.755.076.566.855.22
217274-172746.7606.86
318285-182857.1557.27
417613-176136.8927.00
517843-178436.9827.10
615927-159276.2326.31
20min117378-173786.8006.932.646.967.102.76
217623-176236.8967.07
318622-186227.2877.48
417638-176386.9027.09
517598-175986.8867.08
617363-173636.7946.94
30min118462-184627.2247.171.967.467.421.95
218134-181347.0967.35
318638-186387.2937.56
417694-176946.9247.18
518631-186317.2917.56
618329-183297.1727.40
45min119026-190267.4457.291.547.767.621.60
218636-186367.2937.62
318816-188167.3637.72
418570-185707.2677.60
518629-186297.2907.64
618168-181687.1097.41
60min118860-188607.3807.261.707.787.671.69
218138-181387.0987.51
318794-187947.3547.79
418835-188357.3707.79
518331-183317.1737.60
618347-183477.1797.56
极限117866-178666.9917.222.167.477.722.16
218375-183757.1907.68
318362-183627.1857.70
418625-186257.2887.79
519086-190867.4697.98
618445-184457.2187.68
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