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%
110.442175021877218412185121664217970.41
210.432174821665217060.28
单位质量响应值RSD%判断
2087.842081.110.23数据可信
供试品溶液-2022081801批-培哚普利-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%
5min123863-2386397.67490.835.2897.6790.835.28
222293-2229391.24891.25
322777-2277793.22993.23
420496-2049683.89383.89
522405-2240591.70791.71
621309-2130987.22187.22
10min124402-2440299.88197.771.17100.9798.781.19
223690-2369096.96697.98
323930-2393097.94998.98
423903-2390397.83898.77
523626-2362696.70497.72
623773-2377397.30698.28
15min124247-2424799.24696.481.86101.4498.571.86
223548-2354896.38598.48
323431-2343195.90698.03
423742-2374297.17999.20
523556-2355696.41898.51
622897-2289793.72095.77
20min124061-2406198.48595.681.65101.7898.851.67
223267-2326795.23598.40
323292-2329295.33798.53
423193-2319394.93298.03
523518-2351896.26299.43
622930-2293093.85596.95
30min124133-2413398.78095.791.64103.17100.021.65
223299-2329995.36699.59
323158-2315894.78999.04
423295-2329595.34999.50
523461-2346196.029100.26
623063-2306394.40098.53
45min123566-2356696.45993.402.66101.9598.692.61
223123-2312394.64599.93
322739-2273993.07498.38
421935-2193589.78395.00
523212-2321295.010100.31
622330-2233091.40096.58
极限123370-2337095.65693.931.83102.22100.261.79
223235-2323595.104101.44
322313-2231391.33097.67
422916-2291693.798100.01
523254-2325495.182101.54
622601-2260192.50998.71
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%
113.981639191636711640231638561637921638520.09
213.991637471635321636400.10
单位质量响应值RSD%判断
11720.4611696.930.15数据可信
供试品溶液-2022081801批-氨氯地平-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%
5min1156917-15691786.87782.903.9986.8882.903.99
2151635-15163583.95383.95
3151067-15106783.63883.64
4138824-13882476.86076.86
5151030-15103083.61883.62
6148922-14892282.45182.45
10min1171974-17197495.21393.691.2896.1894.621.27
2167858-16785892.93593.87
3167035-16703592.47993.41
4169698-16969893.95394.81
5167287-16728792.61893.55
6171501-17150194.95295.87
15min1170216-17021694.24092.391.4496.2694.361.42
2165346-16534691.54493.51
3163313-16331390.41892.38
4168321-16832193.19195.09
5166579-16657992.22694.18
6167518-16751892.74694.72
20min1169059-16905993.60091.721.2896.6794.711.28
2165091-16509191.40394.39
3162855-16285590.16593.13
4164869-16486991.28094.21
5165210-16521091.46994.45
6166916-16691692.41395.41
30min1168440-16844093.25791.271.4797.3795.281.47
2163582-16358290.56794.57
3162332-16233289.87593.84
4163977-16397790.78694.73
5163502-16350290.52394.52
6167285-16728592.61796.65
45min1164030-16403090.81589.401.1995.9694.421.19
2160832-16083289.04594.05
3158503-15850387.75592.72
4160986-16098689.13094.09
5161466-16146689.39694.40
6163002-16300290.24695.30
极限1169434-16943493.80792.181.3199.9698.191.29
2166438-16643892.14898.14
3164001-16400190.79996.74
4164625-16462591.14597.09
5168653-16865393.37599.37
6165785-16578591.78797.85
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%
110.442108521108214282119721087211810.69
210.432101920938209780.28
单位质量响应值RSD%判断
2028.832011.310.62数据可信
供试品溶液-2022081801批-培哚普利-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%
5min122424-2242494.71291.322.1694.7191.322.16
221013-2101388.75288.75
321505-2150590.83090.83
421426-2142690.49790.50
521760-2176091.90891.91
621598-2159891.22391.22
10min123526-2352699.36798.920.50100.4299.930.51
223266-2326698.26899.25
323402-2340298.84399.85
423576-2357699.578100.58
523332-2333298.54799.57
623419-2341998.91599.93
15min123235-2323598.13797.621.69100.2999.741.66
223045-2304597.33599.41
322824-2282496.40298.51
423745-23745100.292102.40
523216-2321698.057100.17
622616-2261695.52397.64
20min123064-2306497.41596.110.85100.6699.300.83
222796-2279696.28399.44
322760-2276096.13199.31
422635-2263595.60398.83
522483-2248394.96198.17
622788-2278896.24999.42
30min123211-2321198.03696.771.09102.37101.041.07
222858-2285896.545100.77
322685-2268595.814100.06
423025-2302597.250101.54
523113-2311397.622101.88
622580-2258095.37199.61
45min123304-2330498.42994.842.10103.85100.182.03
221976-2197692.82098.12
322229-2222993.88899.20
422367-2236794.47199.84
522648-2264895.658101.00
622204-2220493.78399.09
极限122759-2275996.12795.161.27102.64101.561.24
222178-2217893.673100.01
322468-2246894.898101.25
422815-2281596.363102.78
522745-2274596.068102.48
622221-2222193.855100.20
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%
113.981626921621361621351624581620491622940.17
213.991617221615801616510.07
单位质量响应值RSD%判断
11609.0111554.750.34数据可信
供试品溶液-2022081801批-氨氯地平-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%
5min1152990-15299085.63182.962.3785.6382.952.37
2142934-14293480.00280.00
3148958-14895883.37483.37
4145788-14578881.60081.60
5150291-15029184.12084.12
6148295-14829583.00383.00
10min1168102-16810294.08993.700.6995.0494.620.69
2166653-16665393.27894.17
3167632-16763293.82694.75
4169163-16916394.68395.59
5165876-16587692.84393.78
6167049-16704993.50094.42
15min1165950-16595092.88592.410.9494.8894.370.94
2163733-16373391.64493.57
3165615-16561592.69794.67
4167556-16755693.78495.74
5164040-16404091.81693.78
6163676-16367691.61293.57
20min1165141-16514192.43291.650.7595.4694.640.75
2162272-16227290.82693.77
3164289-16428991.95594.95
4164952-16495292.32695.33
5163246-16324691.37194.36
6162577-16257790.99793.98
30min1163513-16351391.52191.120.6895.5895.130.68
2161297-16129790.28094.23
3163607-16360791.57395.59
4163611-16361191.57595.60
5161506-16150690.39794.40
6163295-16329591.39995.39
45min1161268-16126890.26489.570.8095.3494.590.80
2157782-15778288.31393.27
3160675-16067589.93294.97
4160948-16094890.08595.13
5159662-15966289.36594.37
6159785-15978589.43494.44
极限1165659-16565992.72291.871.1698.8097.891.12
2162343-16234390.86696.80
3165349-16534992.54898.59
4165502-16550292.63498.68
5164788-16478892.23498.23
6161212-16121290.23396.23
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