布瑞哌唑口服混悬液项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号430038-202402对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数25000
标示量(mg)2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%
111.038285682684825558269882426826440.20
211.028247982630825540.13
单位质量响应值RSD%判断
7492.667491.290.02数据可信
供试品溶液-25082601批-pH4.3
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
10min16665-66657.9679.3841.027.979.3841.01
211559-1155913.81613.82
310885-1088513.01113.01
44700-47005.6185.62
53939-39394.7084.71
69349-934911.17511.17
15min125244-2524430.17442.6714.5430.2642.7714.54
238191-3819145.64945.80
338767-3876746.33746.48
437975-3797545.39145.45
536237-3623743.31343.37
637756-3775645.12945.25
30min146447-4644755.51754.463.7255.9455.033.66
242829-4282951.19351.85
347761-4776157.08857.75
445963-4596354.93955.51
544543-4454353.24153.77
645812-4581254.75855.38
45min149851-4985159.58662.252.3560.6363.442.37
252580-5258062.84864.08
352104-5210462.27963.57
452516-5251662.77163.95
553495-5349563.94165.07
651939-5193962.08263.32
60min157301-5730168.49167.895.7170.1969.765.59
256512-5651267.54869.48
356810-5681067.90469.89
453967-5396764.50666.38
553584-5358464.04865.88
662616-6261674.84476.77
90min155392-5539266.20968.196.8468.6770.826.55
259384-5938470.98073.66
349792-4979259.51562.26
459826-5982671.50974.10
559249-5924970.81973.37
658641-5864170.09272.85
120min160641-6064172.48371.542.0575.6874.921.97
260457-6045772.26375.73
357503-5750368.73272.13
460007-6000771.72575.11
559672-5967271.32574.66
660830-6083072.70976.24
极限1-0.0000.00-4.004.182.81
2-0.0004.27
3-0.0004.17
4-0.0004.18
5-0.0004.13
6-0.0004.34
布瑞哌唑口服混悬液项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号430038-202402对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数25000
标示量(mg)2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%
111.038223682340823678215282326822840.11
211.028245182638825440.17
单位质量响应值RSD%判断
7460.027490.380.29数据可信
供试品溶液-25082601批-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%
10min113570-1357016.25617.507.1116.2617.507.10
215723-1572318.83618.84
313452-1345216.11516.12
414066-1406616.85116.85
515163-1516318.16518.16
615672-1567218.77518.77
15min126690-2669031.97434.077.9632.1534.267.95
232079-3207938.43038.64
326033-2603331.18731.37
429385-2938535.20235.39
527104-2710432.47032.67
629353-2935335.16435.37
30min130189-3018936.16540.048.4936.7040.628.44
238596-3859646.23746.87
332514-3251438.95139.48
432515-3251538.95239.53
534176-3417640.94241.50
632564-3256439.01139.61
45min134686-3468641.55345.647.9142.4946.667.87
240584-4058448.61849.77
333932-3393240.64941.61
440257-4025748.22749.24
538739-3873946.40847.43
640367-4036748.35849.39
60min131544-3154437.78945.8213.1639.1947.3512.93
246379-4637955.56057.25
337018-3701844.34645.76
440530-4053048.55450.10
535325-3532542.31843.85
638707-3870746.37047.94
90min135188-3518842.15449.8212.7343.9751.8512.51
245975-4597555.07657.38
337119-3711944.46746.37
448665-4866558.29960.39
539090-3909046.82948.83
643463-4346352.06754.15
120min141620-4162049.85954.628.5952.1557.218.56
250908-5090860.98663.91
343467-4346752.07254.47
450117-5011760.03862.77
544320-4432053.09455.62
643136-4313651.67554.34
极限144976-4497653.88054.368.3056.7257.568.17
248302-4830257.86461.46
338199-3819945.76148.74
448110-4811057.63461.04
545522-4552254.53457.65
647159-4715956.49559.73
布瑞哌唑口服混悬液项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号430038-202402对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数25000
标示量(mg)2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%
111.038242082553823768235582445824300.10
211.028314583277832110.12
单位质量响应值RSD%判断
7473.257550.910.74数据可信
供试品溶液-25082601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%
10min1401-4010.4780.6124.840.480.6124.87
2695-6950.8290.83
3407-4070.4850.49
4507-5070.6040.60
5413-4130.4920.49
6625-6250.7450.75
15min11007-10071.2001.1115.181.211.1115.19
21068-10681.2731.28
31027-10271.2241.23
4963-9631.1481.15
5716-7160.8540.86
6794-7940.9470.95
30min11227-12271.4631.6617.801.481.6817.73
21570-15701.8721.89
31365-13651.6271.65
41725-17252.0562.08
51027-10271.2241.24
61463-14631.7441.76
45min11634-16341.9482.2627.181.982.3026.87
22598-25983.0973.14
31160-11601.3831.42
41866-18662.2242.27
51763-17632.1022.13
62349-23492.8002.84
60min12312-23122.7562.4638.042.812.5237.35
22286-22862.7252.80
31106-11061.3181.37
43226-32263.8463.91
51240-12401.4781.53
62218-22182.6442.71
90min11874-18742.2342.1530.992.322.2430.22
22410-24102.8732.98
31754-17542.0912.16
42409-24092.8722.98
51328-13281.5831.65
61035-10351.2341.33
120min11906-19062.2722.7229.172.382.8328.82
22751-27513.2793.42
31635-16351.9492.04
43100-31003.6963.84
51542-15421.8381.92
62743-27433.2703.38
极限11602-16021.9102.5432.632.052.6832.03
22800-28003.3383.52
31383-13831.6491.76
43074-30743.6653.85
51663-16631.9822.09
62236-22362.6662.81
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