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%
19.741893618830192651885619284190341.18
29.781994820033199900.31
单位质量响应值RSD%判断
1954.212043.973.18数据不可信!(响应值差异过大,请重新称样测定!)
长期18月-供试品溶液-2022081901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%
5min122695-2269596.91098.231.8396.9198.231.83
223720-23720101.287101.29
323009-2300998.25198.25
423009-2300998.25198.25
522490-2249096.03496.03
623099-2309998.63598.63
10min123188-2318899.01599.521.03100.09100.611.03
223415-2341599.984101.11
323434-23434100.065101.16
423119-2311998.72099.81
523021-2302198.30299.37
623664-23664101.048102.14
15min122933-2293397.92698.351.25100.10100.551.22
222744-2274497.11999.36
322989-2298998.165100.37
422988-2298898.161100.35
522954-2295498.016100.18
623586-23586100.715102.93
20min122627-2262796.61997.621.5499.88100.921.51
222952-2295298.007101.32
322801-2280197.362100.66
423278-2327899.399102.68
522339-2233995.39098.64
623178-2317898.972102.31
30min122152-2215294.59195.921.1798.93100.301.14
222632-2263296.641101.05
322828-2282897.478101.85
422342-2234295.40399.79
522237-2223794.95499.26
622587-2258796.449100.89
45min122029-2202994.06694.460.6599.4699.900.64
222230-2223094.924100.40
322289-2228995.176100.64
421899-2189993.51198.95
522104-2210494.38699.75
622172-2217294.677100.19
极限121660-2166092.49093.760.9998.93100.250.98
222063-2206394.211100.74
321997-2199793.929100.45
421959-2195993.767100.25
521788-2178893.03799.45
622279-2227995.134101.69
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%
114.178049679952804918046880929804670.44
214.188198481039815120.82
单位质量响应值RSD%判断
5678.695748.380.87数据可信
长期18月-供试品溶液-2022081901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%
5min179864-7986490.61694.342.2490.6294.342.24
284036-8403695.35095.35
383815-8381595.09995.10
484507-8450795.88495.88
582033-8203393.07793.08
684636-8463696.03196.03
10min185067-8506796.52097.751.4197.5398.801.41
286013-8601397.59398.65
385336-8533696.82597.88
486736-8673698.41399.48
585447-8544796.95197.99
688301-88301100.189101.26
15min183518-8351894.76296.391.6396.8498.521.62
284165-8416595.49697.64
383833-8383395.12097.25
486359-8635997.986100.14
584967-8496796.40698.52
686857-8685798.551100.73
20min182425-8242593.52295.921.9096.6599.121.89
284564-8456495.94999.15
383728-8372895.00098.19
486683-8668398.353101.60
583723-8372394.99598.18
686100-8610097.692100.97
30min180646-8064691.50393.511.3795.6797.781.38
283174-8317494.37298.64
381662-8166292.65696.90
483288-8328894.50198.84
582212-8221293.28097.52
683527-8352794.77299.13
45min179196-7919689.85891.751.0995.0597.061.10
281110-8111092.03097.35
380618-8061891.47296.75
481392-8139292.35097.74
581614-8161492.60297.88
681235-8123592.17297.59
极限179517-7951790.22291.641.2396.4197.971.24
280841-8084191.72598.07
380029-8002990.80397.09
481578-8157892.56198.98
580456-8045691.28897.59
682178-8217893.24299.68
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%
19.741913419010189881893018987190100.40
29.781936019438193990.29
单位质量响应值RSD%判断
1951.751983.541.15数据可信
长期18月-供试品溶液-2022082001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%
5min122417-2241797.21097.741.7397.2197.741.73
222367-2236796.99396.99
322807-2280798.90198.90
422072-2207295.71495.71
522402-2240297.14597.14
623176-23176100.501100.50
10min122742-2274298.61998.762.1199.7099.852.10
222330-2233096.83397.91
323631-23631102.474103.57
422486-2248697.50998.57
522475-2247597.46198.54
622987-2298799.682100.80
15min122776-2277698.76797.880.88100.94100.060.87
222564-2256497.847100.00
322434-2243497.28499.52
422273-2227396.58598.73
522601-2260198.008100.17
622779-2277998.780101.00
20min121870-2187094.83895.381.6498.1198.661.60
222252-2225296.49499.74
321722-2172294.19697.51
421490-2149093.19096.41
522437-2243797.297100.55
622204-2220496.28699.61
30min121941-2194195.14694.362.1899.4798.702.10
222119-2211995.918100.23
321169-2116991.79896.16
421144-2114491.69095.95
522128-2212895.957100.29
622063-2206395.675100.07
45min121569-2156993.53393.341.0598.9298.721.03
221771-2177194.40999.79
321710-2171094.14499.53
421187-2118791.87697.15
521329-2132992.49297.89
621577-2157793.56799.02
极限121482-2148293.15592.271.9499.5898.691.86
221124-2112491.60398.03
321690-2169094.057100.49
420544-2054489.08895.38
521542-2154293.41699.84
621290-2129092.32398.82
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%
114.178074780716808468092681062808590.18
214.188138481369813760.02
单位质量响应值RSD%判断
5706.355738.790.41数据可信
长期18月-供试品溶液-2022082001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%
5min179771-7977190.36592.841.9890.3792.841.98
281668-8166892.51492.51
383802-8380294.93194.93
480735-8073591.45791.46
581972-8197292.85892.86
683787-8378794.91494.91
10min182635-8263593.60994.671.6894.6195.701.68
282286-8228693.21494.24
385326-8532696.65897.71
482360-8236093.29894.31
585218-8521896.53597.57
683599-8359994.70195.76
15min182496-8249693.45293.901.4495.5095.991.44
283377-8337794.45096.51
384044-8404495.20697.33
480751-8075191.47593.53
582910-8291093.92196.03
683791-8379194.91997.03
20min180586-8058691.28891.821.7994.3794.951.77
281517-8151792.34395.46
382125-8212593.03296.22
478399-7839988.81191.88
582385-8238593.32696.47
681342-8134292.14595.31
30min179400-7940089.94590.651.3194.0494.801.31
280430-8043091.11295.25
380186-8018690.83595.06
478265-7826588.65992.72
581180-8118091.96196.15
680688-8068891.40495.59
45min177876-7787688.21888.881.1493.3194.041.14
279664-7966490.24495.40
379054-7905489.55394.78
477165-7716587.41392.45
578216-7821688.60493.81
678795-7879589.25994.46
极限177553-7755387.85387.951.8393.9394.091.79
277707-7770788.02794.18
379024-7902489.51995.74
475022-7502284.98591.00
578755-7875589.21495.41
677773-7777388.10294.29
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%
19.741922919334192681931819343192980.26
29.781959019463195260.46
单位质量响应值RSD%判断
1981.311996.520.55数据可信
长期18月-供试品溶液-2022082001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%
5min122790-2279097.76595.162.5097.7795.162.50
222351-2235195.88295.88
322574-2257496.83996.84
421801-2180193.52393.52
522299-2229995.65995.66
621275-2127591.26691.27
10min122675-2267597.27296.471.6498.3697.531.62
222463-2246396.36297.43
322808-2280897.84298.92
422600-2260096.95097.99
521775-2177593.41194.47
622611-2261196.99798.01
15min122240-2224095.40696.170.9397.5798.300.90
222269-2226995.53097.67
322486-2248696.46198.62
422731-2273197.51299.63
522223-2222395.33397.43
622560-2256096.77998.87
20min122223-2222395.33394.611.1098.5697.811.08
221741-2174193.26596.46
322193-2219395.20498.44
422334-2233495.80999.01
521794-2179493.49396.65
622046-2204694.57497.74
30min121826-2182693.63093.840.9797.9298.090.95
221685-2168593.02597.26
322211-2221195.28199.57
421852-2185293.74198.01
521650-2165092.87597.07
622024-2202494.47998.70
45min121386-2138691.74292.400.5797.0797.690.53
221484-2148492.16397.43
321526-2152692.34397.69
421556-2155692.47297.78
521523-2152392.33097.56
621758-2175893.33898.61
极限121582-2158292.58392.280.9198.9398.590.88
221533-2153392.37398.66
321562-2156292.49798.87
421615-2161592.72599.06
521120-2112090.60196.86
621650-2165092.87599.18
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%
114.178113581003812408105781317811500.16
214.188124181154811980.08
单位质量响应值RSD%判断
5726.895726.230.01数据可信
长期18月-供试品溶液-2022082001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%
5min182935-8293593.88391.112.4393.8891.112.43
281014-8101491.70891.71
381757-8175792.55092.55
480007-8000790.56990.57
580004-8000490.56590.57
677205-7720587.39787.40
10min183541-8354194.56993.850.9695.6194.860.95
282166-8216693.01394.03
383576-8357694.60995.64
483255-8325594.24595.25
581680-8168092.46293.47
683202-8320294.18595.16
15min183164-8316494.14293.301.1296.2495.361.11
281558-8155892.32494.38
382860-8286093.79895.88
483376-8337694.38296.44
581071-8107191.77393.81
682505-8250593.39695.41
20min181539-8153992.30391.591.1795.4494.681.15
280220-8022090.81093.89
380772-8077291.43594.56
482217-8221793.07096.17
579571-7957190.07593.13
681147-8114791.85994.91
30min180704-8070491.35890.331.2695.5294.441.23
279177-7917789.62993.72
379598-7959890.10694.24
480853-8085391.52695.66
578236-7823688.56492.62
680228-8022890.81994.89
45min179363-7936389.84089.140.7695.0294.250.76
278239-7823988.56793.65
378645-7864589.02794.17
479442-7944289.92995.08
577967-7796788.25993.30
678813-7881389.21794.30
极限179647-7964790.16188.701.4996.3494.801.45
277775-7777588.04294.11
378367-7836788.71294.84
478625-7862589.00495.16
576407-7640786.49392.51
679316-7931689.78695.86
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%
19.741947419579194511956319455195040.32
29.781950620172198392.38
单位质量响应值RSD%判断
2002.462028.530.92数据可信
长期18月-供试品溶液-2022082101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%
5min122958-2295897.19097.832.1297.1997.832.12
222513-2251395.30695.31
323187-2318798.15998.16
423896-23896101.161101.16
523359-2335998.88798.89
622744-2274496.28496.28
10min123429-2342999.18499.001.58100.26100.081.57
223532-2353299.620100.68
323719-23719100.412101.50
423643-23643100.090101.21
523287-2328798.58399.68
622702-2270296.10697.18
15min123010-2301097.41097.811.2499.59100.001.25
223030-2303097.49599.66
323120-2312097.876100.08
423618-2361899.984102.22
523105-2310597.812100.01
622742-2274296.27598.41
20min122578-2257895.58195.511.1598.8598.791.14
222734-2273496.24299.49
322249-2224994.18897.48
422874-2287496.834100.18
522686-2268696.03899.32
622253-2225394.20597.41
30min122624-2262495.77694.851.02100.1099.191.02
222476-2247695.14999.47
322404-2240494.84599.19
422597-2259795.662100.08
522338-2233894.56598.91
621999-2199993.13097.38
45min121970-2197093.00794.561.7798.4099.941.70
222013-2201393.18998.57
322102-2210293.56698.96
422803-2280396.534102.02
522846-2284696.716102.11
622280-2228094.32099.61
极限121246-2124689.94292.963.0796.3799.402.93
221839-2183992.45398.86
321824-2182492.38998.82
423214-2321498.274104.83
522055-2205593.36799.84
621580-2158091.35697.69
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%
114.178211382149821058179281801819920.22
214.188178281683817320.09
单位质量响应值RSD%判断
5786.315763.890.28数据可信
长期18月-供试品溶液-2022082101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%
5min181596-8159691.59193.852.6491.5993.852.64
281486-8148691.46891.47
384291-8429194.61694.62
487028-8702897.68997.69
584953-8495395.36095.36
682271-8227192.34992.35
10min185721-8572196.22295.471.3797.2496.521.37
285126-8512695.55496.57
384503-8450394.85495.91
486865-8686597.50698.59
584646-8464695.01596.07
683459-8345993.68394.71
15min184503-8450394.85494.661.3096.9496.761.29
284748-8474895.12997.21
384199-8419994.51396.62
486107-8610796.65598.82
583341-8334193.55095.67
683075-8307593.25195.32
20min182335-8233592.42192.761.0095.5695.911.01
283336-8333693.54496.68
381852-8185291.87995.03
483755-8375594.01597.26
582843-8284392.99196.15
681679-8167991.68494.79
30min181948-8194891.98691.561.3396.1595.741.31
282513-8251392.62196.80
381640-8164091.64195.82
482755-8275592.89297.18
580331-8033190.17194.36
680210-8021090.03694.16
45min179738-7973889.50690.911.5294.7096.121.48
280245-8024590.07595.28
380000-8000089.80094.99
482930-8293093.08998.41
581764-8176491.78096.97
681275-8127591.23196.35
极限179846-7984689.62789.882.2895.8196.102.20
279470-7947089.20595.41
379293-7929389.00695.20
483599-8359993.840100.19
579924-7992489.71495.92
678324-7832487.91894.05
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%
19.742026519988202022010220104201320.53
29.781925819319192880.23
单位质量响应值RSD%判断
2066.941972.193.32数据不可信!(响应值差异过大,请重新称样测定!)
长期18月-供试品溶液-2022082101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%
5min123259-2325998.31696.622.3198.3296.622.31
222343-2234394.44494.44
323475-2347599.22999.23
423253-2325398.29098.29
522300-2230094.26294.26
622519-2251995.18895.19
10min123045-2304597.41198.292.2898.5099.362.28
222966-2296697.07798.13
323876-23876100.924102.03
423940-23940101.194102.29
523047-2304797.42098.47
622640-2264095.69996.76
15min123109-2310997.68298.043.1499.86100.213.12
223190-2319098.024100.15
324306-24306102.741104.97
423666-23666100.036102.25
522636-2263695.68297.81
622262-2226294.10196.22
20min122586-2258695.47195.601.8698.7398.861.87
222542-2254295.28598.50
323059-2305997.470100.84
423146-2314697.838101.17
522287-2228794.20797.40
622082-2208293.34196.51
30min122565-2256595.38294.831.8799.7099.151.83
222993-2299397.191101.47
322666-2266695.809100.26
422264-2226494.11098.53
522368-2236894.55098.79
621756-2175691.96396.17
45min122287-2228794.20792.992.3899.5998.362.34
222059-2205993.24398.60
322365-2236594.537100.05
422368-2236894.550100.01
521911-2191192.61897.91
621001-2100188.77194.00
极限122195-2219593.81892.082.13100.2598.482.09
222102-2210293.42599.82
321854-2185492.37798.94
422123-2212393.514100.03
521333-2133390.17596.49
621096-2109689.17395.38
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%
114.178125281281812778144081237812970.11
214.188127081117811940.14
单位质量响应值RSD%判断
5737.265725.950.14数据可信
长期18月-供试品溶液-2022082101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%
5min183015-8301593.89193.342.0493.8993.342.04
280994-8099491.60591.61
384193-8419395.22395.22
484535-8453595.61095.61
580400-8040090.93390.93
682047-8204792.79692.80
10min183230-8323094.13495.791.9795.1896.831.96
284194-8419495.22496.24
387200-8720098.62499.68
486317-8631797.62698.69
583841-8384194.82595.84
683372-8337294.29595.33
15min183447-8344794.38095.242.8496.4797.342.81
283988-8398894.99197.07
387080-8708098.489100.64
486687-8668798.044100.19
583457-8345794.39196.45
680608-8060891.16993.25
20min181241-8124191.88593.012.2595.0296.172.24
281800-8180092.51795.65
384265-8426595.30598.55
484727-8472795.82799.06
581327-8132791.98295.09
680063-8006390.55293.64
30min180068-8006890.55891.241.7094.7295.441.70
280571-8057191.12795.29
382344-8234493.13297.44
481414-8141492.08096.38
581281-8128191.93096.06
678369-7836988.63692.73
45min180218-8021890.72890.941.3895.8996.141.41
279973-7997390.45095.62
382106-8210692.86398.20
481342-8134291.99997.32
579588-7958890.01595.17
679184-7918489.55894.64
极限180217-8021790.72690.292.4896.9096.502.43
280298-8029890.81896.99
382858-8285893.713100.09
480351-8035190.87897.22
577765-7776587.95394.11
677484-7748487.63593.71
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