培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8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%
19.761976419771198331984419901198230.29
29.691960619848197270.87
单位质量响应值RSD%判断
2031.052035.810.17数据可信
长期24月-供试品溶液-2022081601批-培哚普利-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min123362-2336298.02496.083.0298.0296.083.03
221858-2185891.71391.71
322850-2285095.87695.88
423899-23899100.277100.28
522609-2260994.86594.86
622819-2281995.74695.75
10min123030-2303096.63197.471.6997.7298.541.70
222994-2299496.48097.50
323324-2332497.86598.93
423941-23941100.453101.57
522835-2283595.81396.87
623262-2326297.60498.67
15min122936-2293696.23796.331.5398.4098.481.54
222635-2263594.97497.06
322871-2287195.96498.12
423626-2362699.132101.36
522733-2273395.38597.50
622950-2295096.29598.44
20min122451-2245194.20295.511.6997.4398.741.69
222622-2262294.91998.07
322835-2283595.81399.03
423507-2350798.632101.96
522581-2258194.74797.93
622587-2258794.77297.99
30min122707-2270795.27694.781.1199.5599.071.13
222381-2238193.90898.11
322494-2249494.38298.67
422976-2297696.404100.83
522297-2229793.55597.79
622683-2268395.17599.45
45min122300-2230093.56892.861.1698.9198.201.17
222005-2200592.33097.57
321979-2197992.22197.55
422471-2247194.28699.78
521776-2177691.36996.64
622258-2225893.39298.72
极限122054-2205492.53692.392.0998.9198.762.04
221702-2170291.05997.33
321590-2159090.58996.95
422887-2288796.031102.58
521912-2191291.94098.23
621968-2196892.17598.54
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.041661131651721657511639921635051649070.69
214.041651351654911653130.16
单位质量响应值RSD%判断
11745.5111774.430.18数据可信
长期24月-供试品溶液-2022081601批-氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1172802-17280295.25593.363.2095.2593.363.20
2160628-16062888.54488.54
3168168-16816892.70092.70
4176776-17677697.44597.45
5169745-16974593.57093.57
6168071-16807192.64792.65
10min1176364-17636497.21896.831.8798.2897.871.88
2170732-17073294.11495.10
3176832-17683297.47698.51
4180641-18064199.576100.66
5174106-17410695.97497.01
6175327-17532796.64797.68
15min1174053-17405395.94495.541.7098.0897.651.71
2169534-16953493.45395.48
3172945-17294595.33497.45
4178226-17822698.245100.43
5171378-17137894.47096.58
6173786-17378695.79797.90
20min1171311-17131194.43394.361.7797.6497.541.79
2167396-16739692.27595.34
3171651-17165194.62097.79
4176523-17652397.306100.59
5169657-16965793.52196.68
6170544-17054494.01097.18
30min1172571-17257195.12793.981.4099.3898.201.42
2167525-16752592.34696.44
3169446-16944693.40597.63
4173868-17386895.842100.20
5168892-16889293.09997.29
6170616-17061694.05098.26
45min1169415-16941593.38892.131.2998.7097.401.31
2164812-16481290.85095.97
3167326-16732692.23697.50
4169756-16975693.57699.00
5164833-16483390.86296.09
6166669-16666991.87497.13
极限1167205-16720592.16991.331.8898.5297.631.87
2162147-16214789.38195.51
3164575-16457590.72097.01
4171118-17111894.326100.79
5164497-16449790.67796.92
6164595-16459590.73197.01
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8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%
19.761994319724197031996219775198210.62
29.691957619799196880.81
单位质量响应值RSD%判断
2030.842031.790.04数据可信
长期24月-供试品溶液-2022081701批-培哚普利-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min123576-2357699.02598.322.2499.0298.322.24
222942-2294296.36296.36
323862-23862100.226100.23
423868-23868100.251100.25
522593-2259394.89694.90
623613-2361399.18099.18
10min123463-2346398.55097.441.0499.6598.541.05
222948-2294896.38797.46
323418-2341898.36199.47
423250-2325097.65698.77
522879-2287996.09797.15
623238-2323897.60598.71
15min123117-2311797.09796.771.4299.2998.951.42
222593-2259394.89697.04
323457-2345798.525100.73
423149-2314997.23199.43
522708-2270895.37997.50
623215-2321597.50999.70
20min122864-2286496.03495.581.3799.3198.831.37
222209-2220993.28396.48
323026-2302696.715100.02
423053-2305396.828100.11
522663-2266395.19098.37
622713-2271395.40098.67
30min122753-2275395.56894.491.2799.9198.801.27
222192-2219293.21297.44
322873-2287396.072100.45
422577-2257794.82999.18
522214-2221493.30497.54
622365-2236593.93898.27
45min121607-2160790.75592.891.9596.1698.251.87
222420-2242094.16999.44
322586-2258694.867100.31
422293-2229393.63699.04
521557-2155790.54595.82
622232-2223293.38098.75
极限122004-2200492.42292.250.6798.8398.640.70
221912-2191292.03698.35
322118-2211892.90199.40
422127-2212792.93999.39
521767-2176791.42797.71
621850-2185091.77598.19
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.041653591654871653981654271658861655110.13
214.041648671658551653610.43
单位质量响应值RSD%判断
11788.5311777.850.07数据可信
长期24月-供试品溶液-2022081701批-氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1175949-17594996.79896.932.0796.8096.932.07
2172417-17241794.85594.86
3177218-17721897.49697.50
4181652-18165299.93699.94
5171959-17195994.60394.60
6177897-17789797.87097.87
10min1176608-17660897.16196.060.9598.2497.140.95
2172709-17270995.01696.07
3176322-17632297.00398.09
4174611-17461196.06297.17
5174579-17457996.04497.10
6172826-17282695.08096.17
15min1173947-17394795.69796.131.5297.8598.281.51
2170960-17096094.05396.16
3177242-17724297.51099.67
4178255-17825598.067100.24
5173575-17357595.49297.61
6174472-17447295.98698.13
20min1174400-17440095.94694.681.3299.1697.901.31
2168578-16857892.74395.90
3172250-17225094.76398.01
4174702-17470296.11299.38
5171424-17142494.30997.49
6171280-17128094.23097.44
30min1173650-17365095.53392.912.0799.8297.181.98
2167865-16786592.35196.54
3172261-17226194.76999.07
4164295-16429590.38794.72
5166836-16683691.78596.01
6168397-16839792.64396.90
45min1167164-16716491.96592.601.3697.3197.901.30
2170329-17032993.70698.92
3170368-17036893.72899.08
4169764-16976493.39698.74
5164591-16459190.55095.80
6167730-16773092.27797.56
极限1164378-16437890.43291.021.3196.8097.351.26
2164893-16489390.71696.97
3167485-16748592.14298.53
4168633-16863392.77399.15
5164464-16446490.48096.73
6162876-16287689.60695.92
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8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%
19.761988519724198281996319917198630.47
29.691972819920198240.69
单位质量响应值RSD%判断
2035.142045.820.38数据可信
长期24月-供试品溶液-2022081801批-培哚普利-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min122846-2284695.52895.592.3495.5395.592.34
223293-2329397.39797.40
321936-2193691.72391.72
423333-2333397.56497.56
523158-2315896.83396.83
622601-2260194.50494.50
10min123125-2312596.69596.262.1297.7697.322.12
223476-2347698.16299.24
322486-2248694.02395.04
423434-2343497.98799.07
523257-2325797.24798.32
622346-2234693.43794.49
15min122959-2295996.00195.821.9398.1497.951.93
223370-2337097.71999.89
322520-2252094.16596.23
423177-2317796.91299.08
523220-2322097.09299.25
622248-2224893.02895.12
20min122471-2247193.96094.601.0297.1697.801.03
223032-2303296.30699.56
322367-2236793.52596.64
422670-2267094.79298.04
522640-2264094.66797.90
622566-2256694.35797.48
30min122331-2233193.37594.091.1697.6298.341.17
222740-2274095.08599.41
322124-2212492.50996.66
422634-2263494.64298.94
522784-2278495.26999.56
622397-2239793.65197.82
45min122033-2203392.12993.031.4597.4198.321.44
222353-2235393.46798.85
322057-2205792.22997.41
422338-2233893.40498.76
522798-2279895.327100.67
621908-2190891.60696.82
极限122268-2226893.11192.280.9899.4298.611.00
222112-2211292.45998.88
321781-2178191.07597.28
422207-2220792.85699.25
522235-2223592.97399.38
621818-2181891.23097.46
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.041655841659161649191655541662541656450.30
214.041644781652661648720.34
单位质量响应值RSD%判断
11798.0811743.020.34数据可信
长期24月-供试品溶液-2022081801批-氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1169873-16987393.55695.052.6393.5695.052.63
2177771-17777197.90697.91
3166542-16654291.72291.72
4177276-17727697.63497.63
5174145-17414595.90995.91
6169905-16990593.57493.57
10min1175043-17504396.40496.012.0697.4497.072.06
2177422-17742297.71498.80
3168885-16888593.01294.03
4177114-17711497.54498.63
5176597-17659797.26098.33
6170926-17092694.13695.18
15min1176070-17607096.96995.622.0399.0897.742.03
2176643-17664397.28599.46
3169591-16959193.40195.45
4174836-17483696.29098.46
5175824-17582496.83498.98
6168702-16870292.91195.00
20min1171106-17110694.23594.430.9297.4297.610.95
2173993-17399395.82599.08
3170005-17000593.62996.72
4171738-17173894.58397.82
5172155-17215594.81398.04
6169719-16971993.47296.59
30min1169414-16941493.30493.410.9997.5497.651.02
2171504-17150494.45598.77
3167464-16746492.23096.36
4170255-17025593.76798.06
5171158-17115894.26498.54
6167894-16789492.46696.62
45min1168047-16804792.55192.291.0897.8297.561.07
2166882-16688291.90997.28
3165324-16532491.05196.21
4167507-16750792.25397.58
5170725-17072594.02699.35
6166913-16691391.92697.11
极限1167033-16703391.99291.221.1298.2997.521.14
2167746-16774692.38598.77
3163022-16302289.78395.95
4165708-16570891.26397.62
5166483-16648391.68998.06
6163839-16383990.23396.44
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8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%
19.763956040005396353980139741397480.44
29.693962139756396880.25
单位质量响应值RSD%判断
4072.544095.770.41数据可信
长期24月-供试品溶液-2022081501批-培哚普利-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min147360-4736098.93895.012.9398.9495.012.93
246158-4615896.42796.43
345317-4531794.67094.67
445536-4553695.12895.13
543296-4329690.44890.45
645216-4521694.45994.46
10min146907-4690797.99296.811.5799.0997.861.56
246546-4654697.23898.31
347127-4712798.45199.50
445576-4557695.21196.27
546552-4655297.25098.26
645333-4533394.70495.75
15min146145-4614596.40096.491.2998.5998.631.27
246966-4696698.115100.27
346530-4653097.20499.35
445185-4518594.39496.51
546055-4605596.21298.30
646258-4625896.63698.74
20min145577-4557795.21395.290.8498.4798.490.82
245629-4562995.32298.56
346028-4602896.15699.38
445359-4535994.75897.92
546030-4603096.16099.31
645050-4505094.11297.29
30min145294-4529494.62294.460.7998.9498.720.79
245113-4511394.24498.55
345779-4577995.63599.93
444850-4485093.69597.91
545403-4540394.85099.07
644849-4484993.69397.91
45min144234-4423492.40892.490.8697.7897.800.85
244832-4483293.65799.01
344538-4453893.04398.40
443733-4373391.36196.62
544131-4413192.19397.47
644163-4416392.25997.52
极限144678-4467893.33592.791.0199.7399.140.98
244551-4455193.07099.46
344635-4463593.24599.64
443764-4376491.42697.70
544908-4490893.816100.12
643979-4397991.87598.16
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.048381683442836378360883527836060.17
214.048313283103831180.03
单位质量响应值RSD%判断
5954.845920.090.42数据可信
长期24月-供试品溶液-2022081501批-氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min186070-8607093.97291.132.8693.9791.132.86
283937-8393791.64391.64
382774-8277490.37390.37
485135-8513592.95192.95
579217-7921786.49086.49
683676-8367691.35891.36
10min185915-8591593.80393.910.6094.8594.920.60
286093-8609393.99795.02
386852-8685294.82695.83
486164-8616494.07495.11
585691-8569193.55894.52
685344-8534493.17994.19
15min184893-8489392.68793.761.1394.7795.811.11
286781-8678194.74896.81
386718-8671894.67996.74
485762-8576293.63695.71
584565-8456592.32994.33
686529-8652994.47396.52
20min183747-8374791.43692.240.7394.5595.330.71
283921-8392191.62694.74
385046-8504692.85495.96
485321-8532193.15496.27
584513-8451392.27295.30
684334-8433492.07695.18
30min182823-8282390.42791.061.9694.5695.181.88
280651-8065188.05592.19
385132-8513292.94897.09
484621-8462192.39096.54
582983-8298390.60194.65
684224-8422491.95696.08
45min180969-8096988.40389.710.9893.5494.850.95
282309-8230989.86694.98
382908-8290890.52095.69
483111-8311190.74195.92
581637-8163789.13294.19
682076-8207689.61194.76
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