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%
111.231008188100816210078501007896100773510079660.02
211.231007751100883310082920.08
单位质量响应值RSD%判断
89756.5489785.570.03数据可信
供试品溶液-24091201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%
5min132941-329413.2943.7414.403.293.7414.48
231537-315373.1543.15
346252-462524.6254.63
435176-351763.5183.52
539118-391183.9123.91
639591-395913.9593.96
10min167123-671236.7136.458.856.756.508.78
265961-659616.5966.63
364412-644126.4416.49
468262-682626.8266.87
553248-532485.3255.37
668135-681356.8146.86
15min164671-646716.4676.834.196.586.944.15
270984-709847.0997.21
370119-701197.0127.14
471267-712677.1277.24
565847-658476.5856.69
666777-667776.6786.80
20min172311-723117.2317.043.427.417.233.41
269347-693476.9357.12
371353-713537.1367.34
471607-716077.1617.36
565924-659246.5936.77
671694-716947.1707.36
30min170717-707177.0727.061.727.347.331.69
268732-687326.8747.14
370266-702667.0277.31
471273-712737.1287.40
570331-703317.0337.28
672382-723827.2397.51
45min173052-730527.3067.142.927.657.492.85
272253-722537.2267.57
370182-701827.0197.38
472555-725557.2567.61
567698-676986.7707.10
672695-726957.2707.62
60min170247-702477.0256.894.977.457.324.56
272313-723137.2327.65
363167-631676.3176.75
469190-691906.9197.35
571767-717677.1777.58
666938-669386.6947.13
极限174437-744377.4447.133.707.957.643.41
270876-708767.0887.59
366702-667026.6707.18
471923-719237.1937.70
573026-730267.3037.79
670941-709417.0947.60
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%
19.922415072416002408882409882411772412320.13
29.932408612417522413060.27
单位质量响应值RSD%判断
24317.7424300.700.05数据可信
供试品溶液-24091201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%
5min12391-23910.9811.1819.760.981.1819.80
22216-22160.9090.91
33587-35871.4711.47
42545-25451.0441.04
53068-30681.2591.26
63411-34111.3991.40
10min16129-61292.5142.5111.342.532.5211.34
25843-58432.3972.41
36647-66472.7272.74
46722-67222.7572.77
54873-48731.9992.01
66485-64852.6602.68
15min16834-68342.8032.985.712.843.025.68
27378-73783.0273.06
37990-79903.2783.32
47318-73183.0023.04
56903-69032.8322.87
67228-72282.9653.01
20min17969-79693.2693.203.953.343.273.98
27688-76883.1543.22
38065-80653.3083.39
47820-78203.2083.28
57245-72452.9723.04
68034-80343.2963.37
30min18270-82703.3923.412.983.503.523.02
27895-78953.2393.34
38416-84163.4523.57
48256-82563.3873.50
58407-84073.4493.55
68639-86393.5443.66
45min18719-87193.5773.572.833.723.722.80
28962-89623.6763.82
38932-89323.6643.82
48690-86903.5653.71
58291-82913.4013.54
68591-85913.5243.68
60min19032-90323.7053.544.893.893.734.47
29006-90063.6943.88
37958-79583.2643.46
48527-85273.4983.69
58889-88893.6463.82
68391-83913.4423.64
极限19458-94583.8803.694.074.103.923.68
29055-90553.7143.94
38337-83373.4203.66
49096-90963.7313.96
58961-89613.6763.89
69071-90713.7213.95
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%
111.231008202100866510083521007879100832610082850.03
211.231008622100849010085560.01
单位质量响应值RSD%判断
89784.9589809.080.02数据可信
供试品溶液-24091201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%
5min148213-482134.8205.3315.184.825.3315.16
261119-611196.1106.11
358613-586135.8605.86
455689-556895.5685.57
556816-568165.6805.68
639368-393683.9363.94
10min162938-629386.2926.747.386.356.807.28
274149-741497.4137.48
367809-678096.7796.84
463761-637616.3756.44
563218-632186.3206.38
672627-726277.2617.30
15min163967-639676.3957.085.786.527.225.74
274414-744147.4407.59
370154-701547.0147.15
475534-755347.5527.68
571055-710557.1047.24
669883-698836.9877.11
20min169862-698626.9847.023.747.187.233.65
272274-722747.2267.46
373166-731667.3157.53
466846-668466.6836.90
567348-673486.7336.95
671518-715187.1507.35
30min168164-681646.8156.938.347.097.228.09
269050-690506.9037.22
372086-720867.2077.51
475326-753267.5317.82
572425-724257.2417.53
658749-587495.8736.15
45min168261-682616.8246.8210.317.177.199.82
275796-757967.5787.97
372065-720657.2057.58
460828-608286.0816.46
558684-586845.8676.23
673619-736197.3607.71
60min170472-704727.0457.103.367.477.553.13
270030-700307.0017.48
369242-692426.9237.38
475054-750547.5047.95
568757-687576.8747.31
672623-726237.2617.69
极限159384-593845.9376.859.146.447.388.64
275367-753677.5358.09
362992-629926.2986.83
474192-741927.4177.94
570213-702137.0207.53
669107-691076.9097.42
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%
19.922515832520132517842516752518242517760.07
29.932519322511002515160.24
单位质量响应值RSD%判断
25380.6525328.900.15数据可信
供试品溶液-24091201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%
5min1-0.0000.67244.950.000.67244.95
210203-102034.0134.01
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min112556-125564.9385.257.394.945.267.64
214678-146785.7735.82
313614-136145.3545.35
412241-122414.8144.81
512769-127695.0225.02
614258-142585.6085.61
15min113821-138215.4366.025.935.496.095.94
215849-158496.2336.34
314737-147375.7965.86
416199-161996.3716.42
516002-160026.2946.35
615247-152475.9976.06
20min115631-156316.1486.193.896.266.324.02
216319-163196.4186.60
316147-161476.3516.47
414615-146155.7485.87
515664-156646.1616.29
616035-160356.3076.44
30min116125-161256.3426.357.496.536.567.20
215991-159916.2896.54
316688-166886.5636.76
417221-172216.7736.96
517000-170006.6866.88
613885-138855.4615.66
45min116248-162486.3906.439.426.646.709.21
217890-178907.0367.36
317378-173786.8357.10
414554-145545.7245.99
514423-144235.6735.94
617563-175636.9087.17
60min117064-170646.7116.822.827.047.162.47
216795-167956.6057.00
316991-169916.6837.03
418015-180157.0857.41
517345-173456.8227.15
617834-178347.0147.35
极限114763-147635.8066.588.606.217.008.25
217968-179687.0677.54
315117-151175.9466.36
418065-180657.1057.51
517412-174126.8487.26
617015-170156.6927.11
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