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%
110.143030473035313032003033683037343033760.09
210.243038053036483037260.04
单位质量响应值RSD%判断
29918.7429660.740.62数据可信
供试品溶液-2025102721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%
5min1112084-11208437.52042.266.1237.5242.266.12
2125956-12595642.16442.16
3124436-12443641.65541.66
4130610-13061043.72243.72
5133760-13376044.77644.78
6130562-13056243.70643.71
10min1229596-22959676.85878.601.6676.9278.671.67
2234116-23411678.37178.44
3231100-23110077.36177.43
4238985-23898580.00180.07
5238639-23863979.88579.96
6236348-23634879.11879.19
15min1269178-26917890.10890.300.9490.3090.500.94
2268701-26870189.94890.15
3266119-26611989.08489.28
4273134-27313491.43291.64
5272052-27205291.07091.28
6269367-26936790.17190.38
20min1286384-28638495.86895.430.8596.2195.790.84
2284432-28443295.21495.57
3281701-28170194.30094.65
4288166-28816696.46496.82
5286615-28661595.94596.30
6283230-28323094.81295.17
30min1299126-299126100.13399.090.89100.6399.600.89
2295722-29572298.99499.50
3292508-29250897.91898.42
4298316-29831699.862100.38
5296881-29688199.38299.90
6293518-29351898.25698.77
45min1302897-302897101.395100.130.94102.06100.800.93
2298964-298964100.079100.75
3295682-29568298.98099.65
4301278-301278100.854101.54
5299495-299495100.257100.94
6296329-29632999.19799.87
60min1303322-303322101.538100.200.98102.37101.040.98
2299711-299711100.329101.17
3295758-29575899.00699.84
4301215-301215100.832101.69
5299795-299795100.357101.21
6296117-29611799.12699.97
极限1306981-306981102.763101.461.01103.77102.471.01
2303594-303594101.629102.64
3297988-29798899.752100.75
4305152-305152102.150103.17
5302547-302547101.278102.30
6302199-302199101.162102.17
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%
110.143036193035813036933036083034983036000.03
210.243039323038633038980.02
单位质量响应值RSD%判断
29940.8329677.540.63数据可信
供试品溶液-2025102721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%
5min1139114-13911446.53843.4612.1546.5443.4612.16
2137378-13737845.95845.96
3105800-10580035.39435.39
4115574-11557438.66338.66
5134499-13449944.99544.99
6147154-14715449.22849.23
10min1239205-23920580.02279.202.3980.1079.272.40
2239666-23966680.17680.25
3228220-22822076.34776.41
4231127-23112777.32077.38
5240054-24005480.30680.38
6242220-24222081.03181.11
15min1271008-27100890.66190.790.6790.8791.000.68
2273223-27322391.40291.61
3270495-27049590.49090.68
4268427-26842789.79889.99
5272914-27291491.29991.51
6272374-27237491.11891.34
20min1284840-28484095.28995.720.4195.6596.080.41
2287455-28745596.16496.53
3286995-28699596.01096.35
4284657-28465795.22895.57
5286761-28676195.93196.29
6286136-28613695.72296.09
30min1293939-29393998.33399.110.6798.8599.630.65
2297677-29767799.583100.11
3299077-299077100.052100.55
4296446-29644699.17199.67
5296186-29618699.08499.61
6294310-29431098.45798.99
45min1296514-29651499.194100.220.8499.88100.900.83
2300352-300352100.478101.17
3303726-303726101.607102.27
4300069-300069100.383101.05
5299225-299225100.101100.79
6297566-29756699.546100.24
60min1297040-29704099.370100.370.84100.22101.220.82
2300783-300783100.622101.48
3304078-304078101.725102.56
4300738-300738100.607101.44
5299676-299676100.252101.10
6297903-29790399.659100.52
极限1300912-300912100.665101.730.70101.68102.740.69
2305454-305454102.185103.21
3307112-307112102.739103.74
4304134-304134101.743102.75
5304000-304000101.698102.72
6302935-302935101.342102.37
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%
110.143039713037723039203039493037603038740.04
210.243033193033493033340.01
单位质量响应值RSD%判断
29967.8529622.460.82数据可信
供试品溶液-2025102821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%
5min1124045-12404541.51742.776.5141.5242.776.51
2127362-12736242.62842.63
3141797-14179747.45947.46
4121477-12147740.65840.66
5119355-11935539.94839.95
6132717-13271744.42044.42
10min1234758-23475878.57379.621.9078.6479.691.90
2235292-23529278.75178.82
3245017-24501782.00682.09
4234327-23432778.42878.50
5235823-23582378.92979.00
6242021-24202181.00481.08
15min1270943-27094390.68491.541.1390.8891.751.13
2268634-26863489.91190.11
3276647-27664792.59392.81
4274660-27466091.92892.13
5274547-27454791.89092.09
6275619-27561992.24992.46
20min1286998-28699896.05796.901.4896.4197.251.48
2283396-28339694.85295.20
3290228-29022897.13897.51
4289371-28937196.85197.20
5296227-29622799.14699.50
6290799-29079997.32997.69
30min1298853-298853100.025100.471.30100.54100.991.30
2293891-29389198.36498.87
3299914-299914100.380100.91
4301182-301182100.805101.32
5305771-305771102.340102.86
6301493-301493100.909101.43
45min1302414-302414101.217101.671.45101.90102.361.45
2296649-29664999.28799.96
3303401-303401101.547102.25
4304814-304814102.020102.70
5310165-310165103.811104.50
6305139-305139102.129102.82
60min1303012-303012101.417102.041.58102.26102.891.57
2297265-29726599.494100.33
3304683-304683101.976102.84
4305890-305890102.380103.23
5311957-311957104.411105.27
6306378-306378102.544103.41
极限1307665-307665102.974103.371.37103.99104.401.37
2302064-302064101.100102.11
3308946-308946103.403104.44
4308673-308673103.312104.33
5315015-315015105.434106.47
6310751-310751104.007105.04
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%
110.143037313040263037933036923037323037950.05
210.243032603035343033970.07
单位质量响应值RSD%判断
29960.0629628.610.79数据可信
供试品溶液-2025102821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%
5min1132534-13253444.36046.034.3544.3646.034.35
2143956-14395648.18348.18
3131644-13164444.06244.06
4133434-13343444.66144.66
5138276-13827646.28246.28
6145301-14530148.63348.63
10min1237101-23710179.35980.451.1679.4380.521.16
2244254-24425481.75381.83
3241406-24140680.80080.87
4237795-23779579.59179.67
5239264-23926480.08380.16
6242325-24232581.10781.19
15min1269818-26981890.30991.080.9390.5291.280.93
2273877-27387791.66891.88
3275740-27574092.29292.50
4269865-26986590.32590.53
5270154-27015490.42290.63
6273192-27319291.43991.65
20min1283892-28389295.02095.821.0695.3896.191.06
2288092-28809296.42696.80
3291136-29113697.44597.81
4283532-28353294.90095.26
5284057-28405795.07595.44
6287023-28702396.06896.44
30min1293075-29307598.09498.871.1498.6199.401.13
2295590-29559098.93599.47
3301623-301623100.955101.48
4292717-29271797.97498.49
5293403-29340398.20398.72
6296009-29600999.07699.60
45min1294915-29491598.70999.611.1599.39100.301.15
2297566-29756699.597100.29
3303868-303868101.706102.40
4295120-29512098.77899.46
5295480-29548098.89999.58
6298736-29873699.988100.68
60min1295182-29518298.79999.601.1599.64100.461.15
2297564-29756499.596100.46
3304154-304154101.802102.66
4294976-29497698.73099.57
5296022-29602299.08099.93
6297604-29760499.609100.47
极限1296472-29647299.231100.751.22100.24101.771.22
2301837-301837101.026102.05
3307170-307170102.811103.84
4298897-298897100.042101.05
5299586-299586100.273101.29
6302074-302074101.106102.13
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%
110.142980802992302980142979022981902982830.19
210.242980642977072978860.09
单位质量响应值RSD%判断
29416.4729090.430.79数据可信
供试品溶液-2025102921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%
5min1149662-14966251.01950.043.4851.0250.043.48
2147989-14798950.44850.45
3137362-13736246.82646.83
4149411-14941150.93350.93
5144918-14491849.40249.40
6151404-15140451.61351.61
10min1247089-24708984.23183.860.9084.3283.940.90
2245777-24577783.78483.87
3243089-24308982.86782.95
4245634-24563483.73583.82
5244809-24480983.45483.54
6249578-24957885.08085.17
15min1276601-27660194.29193.970.5994.5294.200.59
2274788-27478893.67393.90
3274395-27439593.53993.76
4274017-27401793.41193.64
5275906-27590694.05594.28
6278273-27827394.86195.09
20min1290109-29010998.89698.090.6499.2898.470.64
2287037-28703797.84998.23
3286928-28692897.81298.18
4284955-28495597.13997.52
5288477-28847798.34098.72
6288983-28898398.51298.90
30min1296269-296269100.996100.840.53101.54101.380.53
2295406-295406100.702101.24
3294957-294957100.549101.08
4293600-293600100.086100.63
5298199-298199101.654102.20
6296371-296371101.031101.58
45min1298716-298716101.830101.740.55102.55102.450.55
2298643-298643101.805102.52
3298333-298333101.700102.40
4295466-295466100.722101.43
5300459-300459102.425103.14
6299005-299005101.929102.65
60min1300357-300357102.390102.340.69103.28103.220.69
2299497-299497102.097102.98
3299813-299813102.204103.08
4297184-297184101.308102.18
5303517-303517103.467104.35
6300956-300956102.594103.48
极限1305720-305720104.218104.090.75105.27105.140.75
2304718-304718103.876104.93
3304231-304231103.710104.75
4301827-301827102.891103.94
5307344-307344104.772105.83
6308169-308169105.053106.11
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%
110.142980242980632979612978772978552979560.04
210.242973752974192973970.02
单位质量响应值RSD%判断
29384.2229042.680.83数据可信
供试品溶液-2025102921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%
5min1151638-15163851.76349.665.6851.7649.665.68
2152199-15219951.95551.95
3142631-14263148.68948.69
4154154-15415452.62252.62
5136848-13684846.71546.71
6135472-13547246.24546.24
10min1244850-24485083.58283.490.7983.6783.570.79
2245853-24585383.92584.01
3241207-24120782.33982.42
4246850-24685084.26584.35
5244552-24455283.48183.56
6244166-24416683.34983.43
15min1271676-27167692.74093.681.0592.9793.901.05
2276814-27681494.49494.72
3270647-27064792.38892.61
4274207-27420793.60493.83
5278033-27803394.91095.13
6275185-27518593.93894.15
20min1282309-28230996.36997.631.2096.7598.011.19
2288711-28871198.55598.94
3282040-28204096.27896.65
4286077-28607797.65698.04
5290622-29062299.20799.58
6286319-28631997.73898.11
30min1288126-28812698.355100.141.5498.90100.681.53
2295374-295374100.829101.38
3289411-28941198.79499.33
4292340-29234099.794100.34
5300555-300555102.598103.14
6294345-294345100.478101.01
45min1290386-29038699.127100.941.5699.83101.641.55
2298049-298049101.742102.46
3291391-29139199.470100.17
4294630-294630100.575101.29
5302814-302814103.369104.08
6296873-296873101.341102.04
60min1291786-29178699.604101.181.59100.47102.051.58
2299279-299279102.162103.05
3291403-29140399.474100.34
4294716-294716100.605101.49
5303607-303607103.640104.52
6297563-297563101.576102.45
极限1297208-297208101.455102.641.34102.49103.691.34
2302388-302388103.224104.28
3296655-296655101.267102.30
4297756-297756101.642102.69
5306252-306252104.543105.60
6303873-303873103.730104.77
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