贝派度酸依折麦布片项目信息
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%
110.969853829851889837639835549826849841140.12
210.959858909847119853000.09
单位质量响应值RSD%判断
89791.4289981.740.15数据可信
供试品溶液-2025112921批-依折麦布-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min149157-491574.9105.246.114.915.246.09
248684-486844.8624.86
354356-543565.4295.43
452019-520195.1955.20
557019-570195.6955.69
653697-536975.3635.36
10min171609-716097.1527.432.247.217.492.24
273772-737727.3687.42
374988-749887.4897.55
474643-746437.4557.51
575046-750467.4957.56
676600-766007.6507.71
15min173641-736417.3557.602.077.497.742.07
276573-765737.6487.78
375893-758937.5807.72
477856-778567.7767.92
577564-775647.7477.89
675173-751737.5087.65
20min175881-758817.5797.691.807.797.911.75
278333-783337.8248.04
376618-766187.6527.88
479005-790057.8918.12
576389-763897.6297.86
675596-755967.5507.78
30min177135-771357.7047.711.518.008.021.50
277473-774737.7388.05
375987-759877.5897.90
479106-791067.9018.22
577483-774837.7398.06
676005-760057.5917.90
45min177376-773767.7287.740.888.118.140.87
278048-780487.7958.19
376536-765367.6448.04
478465-784657.8378.24
577258-772587.7168.12
677211-772117.7128.11
60min174626-746267.4537.641.427.928.121.41
277725-777257.7638.24
377062-770627.6978.18
477177-771777.7088.20
576450-764507.6368.12
676198-761987.6108.09
极限175737-757377.5647.651.338.128.221.30
277885-778857.7798.35
377089-770897.6998.27
477263-772637.7178.29
576563-765637.6478.22
675157-751577.5068.07
贝派度酸依折麦布片项目信息
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%
110.192537962542312533332525792524022532680.31
210.272544542542062543300.07
单位质量响应值RSD%判断
24854.5624764.360.26数据可信
供试品溶液-2025112921批-贝派度酸-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min15344-53442.1482.437.882.152.437.83
25894-58942.3692.37
35734-57342.3052.30
46356-63562.5552.55
56626-66262.6632.66
66347-63472.5512.55
10min18256-82563.3183.363.083.343.383.14
28103-81033.2573.28
38210-82103.3003.33
48222-82223.3053.33
58496-84963.4153.44
68800-88003.5373.57
15min18971-89713.6063.643.133.673.703.10
29018-90183.6253.69
38879-88793.5693.63
48856-88563.5603.62
58979-89793.6093.68
69619-96193.8663.93
20min19070-90703.6463.622.983.753.722.90
28854-88543.5593.66
38965-89653.6033.71
49254-92543.7203.82
58566-85663.4433.55
69277-92773.7293.84
30min19120-91203.6663.690.693.813.830.70
29151-91513.6783.82
39246-92463.7163.86
49247-92473.7173.86
59102-91023.6593.80
69210-92103.7023.85
45min19318-93183.7453.752.143.933.942.08
29084-90843.6513.83
39672-96723.8884.07
49307-93073.7413.93
59218-92183.7053.89
69418-94183.7863.98
60min18697-86973.4963.673.303.723.903.19
29408-94083.7814.01
38853-88533.5583.78
49109-91093.6613.89
59434-94343.7924.02
69268-92683.7253.96
极限19015-90153.6243.722.303.893.992.26
29067-90673.6443.91
39191-91913.6943.96
49570-95703.8474.12
59267-92673.7253.99
69427-94273.7894.07
贝派度酸依折麦布片项目信息
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%
110.969833259852829833079848759840299841640.10
210.959840189845709842940.04
单位质量响应值RSD%判断
89795.9989889.860.08数据可信
供试品溶液-2025112921批-依折麦布-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min149382-493824.9344.6818.024.934.6818.00
232878-328783.2853.29
341079-410794.1054.10
455330-553305.5295.53
549029-490294.8994.90
653561-535615.3525.35
10min172492-724927.2447.242.767.307.292.84
268583-685836.8536.89
372279-722797.2227.27
474071-740717.4027.46
573450-734507.3397.39
673559-735597.3507.41
15min174578-745787.4527.540.977.597.680.98
274962-749627.4917.60
376528-765287.6477.77
475200-752007.5147.66
575474-754747.5427.68
676130-761307.6077.75
20min176402-764027.6347.650.637.857.860.50
277018-770187.6967.89
376811-768117.6757.89
475737-757377.5687.80
576262-762627.6207.84
676844-768447.6797.90
30min174668-746687.4617.651.307.767.941.25
277483-774837.7428.02
376426-764267.6377.93
476923-769237.6868.00
576408-764087.6357.94
677159-771597.7108.02
45min174962-749627.4917.651.537.888.041.51
276216-762167.6167.98
376667-766677.6618.04
478321-783217.8268.22
575858-758587.5807.97
677324-773247.7278.12
60min175764-757647.5717.630.938.048.100.77
277663-776637.7608.21
376779-767797.6728.14
476011-760117.5958.08
575966-759667.5918.06
676180-761807.6128.09
极限174773-747737.4727.580.868.028.130.83
276189-761897.6138.15
376604-766047.6558.21
475700-757007.5648.13
575526-755267.5478.10
676196-761967.6148.18
贝派度酸依折麦布片项目信息
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%
110.192536182541042534992537622530302536030.16
210.272531762538772535260.20
单位质量响应值RSD%判断
24887.4424686.080.58数据可信
供试品溶液-2025112921批-贝派度酸-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min15325-53252.1421.7850.022.141.7850.01
2-0.0000.00
34541-45411.8271.83
45611-56112.2572.26
55174-51742.0822.08
65852-58522.3542.35
10min17780-77803.1303.254.353.153.274.51
27707-77073.1013.10
37794-77943.1363.16
48334-83343.3533.38
58503-85033.4213.44
68332-83323.3523.38
15min18604-86043.4623.452.083.523.502.30
28320-83203.3473.38
38558-85583.4433.50
48504-85043.4213.48
58528-85283.4313.49
68866-88663.5673.63
20min18776-87763.5313.574.103.633.663.94
28973-89733.6103.68
39036-90363.6353.73
49243-92433.7193.82
58198-81983.2983.40
69023-90233.6303.73
30min18853-88533.5623.641.183.703.771.19
29063-90633.6463.76
39004-90043.6223.76
49091-90913.6573.80
59173-91733.6903.83
69057-90573.6443.79
45min19200-92003.7013.762.843.883.932.88
29119-91193.6693.82
39584-95843.8564.03
49605-96053.8644.05
58996-89963.6193.80
69526-95263.8324.02
60min18968-89683.6083.724.013.823.943.80
29352-93523.7623.96
39478-94783.8134.03
49784-97843.9364.16
59200-92003.7013.92
68743-87433.5173.74
极限19436-94363.7963.732.524.053.982.48
29180-91803.6933.93
39338-93383.7574.02
49180-91803.6933.96
58887-88873.5753.83
69544-95443.8404.11
贝派度酸依折麦布片项目信息
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%
110.969843029849149844369839329834319842030.06
210.959860609857649859120.03
单位质量响应值RSD%判断
89799.5490037.630.19数据可信
供试品溶液-2025112921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%
5min141156-411564.1094.5914.834.114.5914.87
256143-561435.6055.61
347931-479314.7854.79
449430-494304.9354.94
536674-366743.6623.66
644252-442524.4184.42
10min172002-720027.1897.442.847.237.492.92
276001-760017.5887.65
376025-760257.5907.64
476411-764117.6297.68
571725-717257.1617.20
674999-749997.4887.54
15min176517-765177.6397.702.947.777.832.95
281380-813808.1258.27
375620-756207.5507.69
475885-758857.5767.72
575426-754267.5317.65
677816-778167.7697.90
20min176018-760187.5907.631.877.807.851.94
277760-777607.7648.00
376935-769357.6817.90
477100-771007.6987.92
573792-737927.3677.57
677153-771537.7037.92
30min176677-766777.6557.751.217.958.061.25
277600-776007.7488.07
377749-777497.7628.07
479402-794027.9288.24
577187-771877.7067.99
677375-773757.7258.03
45min174901-749017.4787.721.897.868.121.86
278417-784177.8298.24
378517-785177.8398.23
478154-781547.8038.20
577918-779187.7798.15
676284-762847.6168.01
60min177595-775957.7477.701.598.218.181.54
278312-783127.8198.31
374766-747667.4657.94
477502-775027.7388.22
577120-771207.7008.16
677548-775487.7428.22
极限176159-761597.6047.670.858.158.230.88
276989-769897.6878.27
376441-764417.6328.19
477821-778217.7708.34
577151-771517.7038.25
676186-761867.6068.17
贝派度酸依折麦布片项目信息
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%
110.192541162531602534072534862538852536110.16
210.272540692539702540200.03
单位质量响应值RSD%判断
24888.2224734.180.44数据可信
供试品溶液-2025112921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%
5min17297-72972.9333.3818.942.933.3818.94
210781-107814.3334.33
38872-88723.5663.57
49236-92363.7123.71
56224-62242.5022.50
68026-80263.2263.23
10min116240-162406.5276.534.566.566.574.61
216517-165176.6386.69
316423-164236.6016.64
417069-170696.8606.90
514856-148565.9716.00
616415-164156.5986.63
15min117987-179877.2297.094.057.337.204.04
218341-183417.3727.49
316763-167636.7376.85
418167-181677.3027.42
516726-167266.7226.82
617840-178407.1707.28
20min118439-184397.4117.341.887.607.531.77
217937-179377.2097.41
318164-181647.3007.49
418624-186247.4857.68
518577-185777.4667.64
617807-178077.1577.35
30min118663-186637.5017.561.227.777.831.20
218899-188997.5967.88
319235-192357.7318.00
418634-186347.4897.77
518674-186747.5057.76
618797-187977.5557.82
45min118157-181577.2987.733.087.658.092.98
219250-192507.7378.11
319984-199848.0328.39
419384-193847.7918.16
519286-192867.7518.09
619317-193177.7648.12
60min119076-190767.6677.752.188.108.192.13
219380-193807.7898.24
319031-190317.6498.09
420054-200548.0608.51
519345-193457.7758.20
618875-188757.5868.02
极限119430-194307.8097.761.558.338.291.37
219205-192057.7198.26
319342-193427.7748.30
418834-188347.5708.11
519306-193067.7598.27
619747-197477.9378.46
贝派度酸依折麦布片项目信息
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%
110.969868859869249872509887319861219871820.10
210.959828799839379834080.08
单位质量响应值RSD%判断
90071.3589808.950.21数据可信
供试品溶液-2025112921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%
5min149120-491204.9035.788.844.905.788.85
255777-557775.5675.57
362160-621606.2056.20
457113-571135.7015.70
560212-602126.0106.01
662915-629156.2806.28
10min173781-737817.3657.632.247.427.692.26
277781-777817.7647.83
378285-782857.8147.88
477387-773877.7257.79
575402-754027.5267.59
675861-758617.5727.64
15min177799-777997.7667.761.707.907.911.63
280001-800017.9858.13
378154-781547.8017.96
477462-774627.7327.88
576821-768217.6687.82
676157-761577.6027.76
20min174521-745217.4387.732.177.667.972.18
279383-793837.9248.16
378749-787497.8608.10
477391-773917.7257.96
577529-775297.7397.97
677279-772797.7147.95
30min176024-760247.5887.792.077.898.112.09
280179-801798.0038.33
379566-795667.9428.27
478034-780347.7898.11
576654-766547.6517.97
677703-777037.7568.08
45min177384-773847.7247.691.258.118.091.18
278023-780237.7888.20
377347-773477.7218.14
476451-764517.6318.04
577456-774567.7318.14
675337-753377.5207.93
60min176475-764757.6337.691.858.118.191.78
278318-783187.8178.32
377676-776767.7538.26
478848-788487.8708.36
575569-755697.5438.04
675503-755037.5368.03
极限177107-771077.6977.721.008.268.301.01
277930-779307.7798.37
378056-780567.7918.38
477053-770537.6918.27
577801-778017.7668.34
676007-760077.5878.16
贝派度酸依折麦布片项目信息
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%
110.192545902550302548392556832544562549200.19
210.272537102539332538220.07
单位质量响应值RSD%判断
25016.6824714.900.86数据可信
供试品溶液-2025112921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%
5min18657-86573.4724.079.503.474.089.53
29718-97183.8973.90
311270-112704.5204.52
49749-97493.9103.91
510910-109104.3754.38
610650-106504.2714.27
10min114796-147965.9345.963.265.976.013.22
214886-148865.9706.01
315564-155646.2426.29
414712-147125.9005.94
514105-141055.6575.71
615136-151366.0706.12
15min115561-155616.2416.211.806.356.321.76
215468-154686.2036.31
315653-156536.2786.40
415845-158456.3556.46
515117-151176.0636.17
615189-151896.0926.21
20min115461-154616.2016.352.836.376.532.82
216624-166246.6676.85
316074-160746.4466.64
415466-154666.2036.38
515780-157806.3296.51
615622-156226.2656.45
30min115881-158816.3696.663.306.616.923.25
217421-174216.9877.24
316752-167526.7186.98
416477-164776.6086.86
516214-162146.5036.75
616950-169506.7987.05
45min116317-163176.5446.643.016.866.972.87
217117-171176.8657.19
316654-166546.6797.01
416316-163166.5436.87
517131-171316.8707.19
615871-158716.3656.69
60min117199-171996.8986.912.267.287.302.11
217185-171856.8927.30
316806-168066.7407.15
417587-175877.0537.45
516798-167986.7377.13
617742-177427.1157.51
极限116474-164746.6076.813.187.077.292.99
217181-171816.8907.37
316961-169616.8027.29
417429-174296.9907.46
517613-176137.0647.54
616237-162376.5126.99
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