贝派度酸片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号BEMA-231010D对照品来源自制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50
标示量(mg)180供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.053026113023563022453022373023463023590.06
29.973022453025543024000.08
单位质量响应值RSD%判断
30085.4730330.990.58数据可信
供试品溶液-1批-pH6.6
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1131739-13173943.48942.642.0143.4942.642.01
2130828-13082843.18843.19
3131455-13145543.39543.40
4128797-12879742.51842.52
5125848-12584841.54441.54
6126371-12637141.71741.72
10min1227407-22740775.07074.360.8875.1474.430.88
2225125-22512574.31774.39
3222837-22283773.56273.63
4227736-22773675.17975.25
5223585-22358573.80973.88
6224884-22488474.23774.31
15min1254635-25463584.05983.770.9584.2683.960.95
2253328-25332883.62783.82
3250265-25026582.61682.81
4257376-25737684.96385.16
5252327-25232783.29783.49
6254560-25456084.03484.23
20min1267104-26710488.17588.071.0788.5188.411.07
2265709-26570987.71488.05
3262818-26281886.76087.09
4270752-27075289.37989.72
5265308-26530887.58287.91
6269102-26910288.83489.17
30min1278633-27863391.98192.691.0792.4793.181.07
2280048-28004892.44892.93
3277283-27728391.53592.01
4284979-28497994.07694.56
5280019-28001992.43892.92
6283814-28381493.69194.17
45min1289623-28962395.60996.511.1596.2597.151.15
2291479-29147996.22196.86
3288669-28866995.29495.92
4296760-29676097.96598.61
5291469-29146996.21896.85
6296152-29615297.76498.40
60min1294724-29472497.29398.231.1998.0999.021.18
2296072-29607297.73898.53
3293810-29381096.99197.78
4301919-30191999.668100.47
5296994-29699498.04298.83
6301827-30182799.637100.44
极限1297660-29766098.26299.531.2099.22100.491.20
2300220-30022099.107100.07
3298161-29816198.42799.38
4306153-306153101.065102.04
5301341-30134199.477100.43
6305508-305508100.853101.82
贝派度酸片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号BEMA-231010D对照品来源自制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50
标示量(mg)180供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.053016173018083017993015753015573016710.05
29.973011243012503011870.03
单位质量响应值RSD%判断
30017.0130209.330.46数据可信
供试品溶液-2批-pH6.6
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1106734-10673435.34536.968.5935.3536.968.58
2125817-12581741.66541.66
3104896-10489634.73734.74
4118624-11862439.28339.28
5113650-11365037.63637.64
699986-9998633.11133.11
10min1219132-21913272.56673.791.3472.6373.851.34
2223285-22328573.94274.01
3220781-22078173.11373.17
4227371-22737175.29575.36
5224842-22484274.45774.52
6221567-22156773.37373.43
15min1251276-25127683.21184.311.1683.3984.501.16
2251660-25166083.33883.53
3253765-25376584.03584.22
4258697-25869785.66985.86
5255136-25513684.48984.68
6257042-25704285.12185.30
20min1265862-26586288.04188.961.2388.3689.291.22
2264121-26412187.46587.80
3268180-26818088.80989.13
4272209-27220990.14390.48
5269313-26931389.18489.51
6272149-27214990.12390.44
30min1280689-28068992.95193.651.1993.4294.131.18
2277600-27760091.92892.41
3282956-28295693.70294.17
4286085-28608594.73895.22
5283045-28304593.73294.21
6286495-28649594.87495.34
45min1292251-29225196.78097.231.1997.4097.861.19
2287536-28753695.21995.85
3294891-29489197.65498.28
4295873-29587397.98098.62
5293633-29363397.23897.87
6297526-29752698.52799.15
60min1297362-29736298.47398.721.1799.2599.511.17
2291865-29186596.65297.44
3299298-29929899.11499.90
4300145-30014599.394100.20
5297929-29792998.66099.45
6302033-302033100.019100.81
极限1301644-30164499.89199.861.17100.84100.821.16
2295169-29516997.74698.70
3302894-302894100.305101.26
4302983-302983100.334101.30
5300974-30097499.669100.63
6305681-305681101.228102.19
贝派度酸片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号BEMA-231010D对照品来源自制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50
标示量(mg)180供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.053025553023053025483025523026583025240.05
29.973012143009773010960.06
单位质量响应值RSD%判断
30101.8930200.200.24数据可信
供试品溶液-24042201批-pH6.6
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min196822-9682232.02231.685.8632.0231.685.87
292338-9233830.53930.54
3101648-10164833.61933.62
4101335-10133533.51533.52
595760-9576031.67131.67
686875-8687528.73328.73
10min1201939-20193966.78866.160.9066.8466.210.90
2202168-20216866.86466.92
3200027-20002766.15666.21
4199725-19972566.05666.11
5198839-19883965.76365.82
6197496-19749665.31965.37
15min1239149-23914979.09578.410.9379.2678.580.93
2240264-24026479.46479.63
3234887-23488777.68677.85
4234992-23499277.72077.89
5236409-23640978.18978.35
6236843-23684378.33278.49
20min1258337-25833785.44184.640.9985.7484.930.99
2259106-25910685.69685.99
3253002-25300283.67783.97
4253182-25318283.73684.03
5255728-25572884.57884.87
6256111-25611184.70584.99
30min1276097-27609791.31590.400.9391.7590.830.92
2275777-27577791.20991.65
3270295-27029589.39689.83
4270447-27044789.44689.88
5273308-27330890.39390.83
6274013-27401390.62691.05
45min1287830-28783095.19694.040.9195.7994.620.91
2286402-28640294.72395.31
3281214-28121493.00893.59
4281745-28174593.18393.77
5284044-28404493.94394.53
6284765-28476594.18294.76
60min1293884-29388497.19895.831.0097.9596.581.00
2291555-29155596.42897.18
3286766-28676694.84495.58
4286315-28631594.69595.43
5289467-28946795.73796.48
6290567-29056796.10196.84
极限1297628-29762898.43696.921.0599.3597.821.05
2295106-29510697.60298.51
3290410-29041096.04996.95
4289278-28927895.67596.57
5293439-29343997.05197.95
6292446-29244696.72297.62
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