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%
110.152078520597207592071520618206950.41
210.272067320678206760.02
单位质量响应值RSD%判断
2038.922013.240.90数据可信
供试品溶液-2022081901批-培哚普利-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min123301-2330198.12797.962.7098.1397.962.70
223292-2329298.08998.09
323665-2366599.65999.66
422891-2289196.40096.40
524116-24116101.559101.56
622297-2229793.89893.90
10min123351-2335198.33799.461.7999.43100.551.79
223793-23793100.198101.29
323850-23850100.438101.55
423190-2319097.65998.73
524265-24265102.186103.31
623261-2326197.95899.00
15min123148-2314897.48298.391.8799.67100.581.87
223006-2300696.88499.09
323814-23814100.287102.51
423244-2324497.886100.04
523998-23998101.062103.33
622970-2297096.73398.86
20min122884-2288496.37097.222.4599.64100.512.43
223146-2314697.474100.75
323506-2350698.990102.33
422727-2272795.70998.95
523913-23913100.704104.09
622342-2234294.08897.29
30min122677-2267795.49996.402.3499.84100.762.32
222579-2257995.08699.45
323217-2321797.773102.21
422491-2249194.71599.02
523836-23836100.380104.89
622539-2253994.91899.17
45min122253-2225393.71394.652.0599.11100.082.05
222208-2220893.52498.94
322971-2297196.737102.26
422145-2214593.25898.62
523149-2314997.486103.11
622122-2212293.16198.47
极限122394-2239494.30793.962.13100.75100.462.10
222653-2265395.398101.86
322288-2228893.861100.46
421954-2195492.45498.85
522953-2295396.661103.37
621632-2163291.09897.44
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%
114.528313382606821868278082530826470.42
214.638233582218822760.11
单位质量响应值RSD%判断
5691.945623.790.86数据可信
供试品溶液-2022081901批-氨氯地平-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min130182-3018234.58236.275.6034.5836.275.60
232004-3200436.67036.67
329507-2950733.80933.81
433261-3326138.11038.11
534045-3404539.00939.01
630952-3095235.46535.46
10min154586-5458662.54470.6110.1562.9371.0210.10
253125-5312560.87061.28
362977-6297772.15972.53
466602-6660276.31276.74
567727-6772777.60178.03
664750-6475074.19074.58
15min169161-6916179.24483.965.2380.3285.155.26
267758-6775877.63778.72
375939-7593987.01088.19
475956-7595687.03088.30
576542-7654287.70189.00
674306-7430685.13986.36
20min175570-7557086.58888.232.7288.5590.352.79
274010-7401084.80086.75
378803-7880390.29292.44
477652-7765288.97391.21
579613-7961391.22093.49
676358-7635887.49189.65
30min179034-7903490.55791.662.4893.4894.762.53
277297-7729788.56691.46
381732-8173293.64896.80
479342-7934290.91094.14
582800-8280094.87298.16
679761-7976191.39094.53
45min178143-7814389.53692.043.0193.4696.163.06
277699-7769989.02792.90
381943-8194393.89098.08
480035-8003591.70495.94
584166-8416696.437100.77
679991-7999191.65395.81
极限178540-7854089.99191.681.8894.9196.822.00
278323-7832389.74294.60
380571-8057192.31897.55
480725-8072592.49497.75
582312-8231294.31399.72
679591-7959191.19596.37
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%
110.152045320515205372078320527205630.62
210.272067620815207460.48
单位质量响应值RSD%判断
2025.912020.060.21数据可信
供试品溶液-2022082101批-培哚普利-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min123324-2332498.37099.151.7998.3799.151.79
222948-2294896.78496.78
323694-2369499.93099.93
423186-2318697.78897.79
523899-23899100.795100.79
624000-24000101.221101.22
10min124179-24179101.976100.571.40103.07101.671.40
223311-2331198.31599.39
323998-23998101.213102.32
423644-2364499.719100.81
524149-24149101.849102.97
623793-23793100.348101.47
15min123895-23895100.77899.341.64103.00101.561.63
223042-2304297.18199.35
323680-2368099.871102.11
423108-2310897.45999.65
523913-23913100.854103.11
623686-2368699.897102.14
20min123558-2355899.35797.961.29102.70101.281.29
222921-2292196.67099.92
323398-2339898.682102.03
422804-2280496.17799.45
523396-2339698.674102.05
623277-2327798.172101.52
30min123053-2305397.22797.401.55101.68101.811.53
222409-2240994.51198.83
323150-2315097.636102.08
423233-2323397.986102.33
523410-2341098.733103.20
623309-2330998.307102.75
45min122805-2280596.18195.701.19101.71101.201.19
222277-2227793.95499.33
323045-2304597.193102.72
422495-2249594.874100.31
522794-2279496.135101.70
622730-2273095.865101.40
极限122639-2263995.48194.691.45102.08101.241.43
221827-2182792.05698.47
322586-2258695.257101.86
422368-2236894.338100.83
522655-2265595.548102.18
622629-2262995.439102.04
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%
114.528217981731822658195881581819430.36
214.638212882137821320.01
单位质量响应值RSD%判断
5643.465613.940.38数据可信
供试品溶液-2022082101批-氨氯地平-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min156063-5606364.56866.532.8364.5766.522.83
257380-5738066.08466.08
357875-5787566.65466.65
457062-5706265.71865.72
557338-5733866.03666.04
660862-6086270.09570.09
10min174360-7436085.64084.521.8986.3685.261.87
271424-7142482.25982.99
374413-7441385.70186.44
472610-7261083.62584.35
574959-7495986.33087.06
672574-7257483.58384.36
15min177165-7716588.87188.451.7590.5490.131.74
275473-7547386.92288.57
377574-7757489.34291.03
475401-7540186.83988.50
578882-7888290.84892.54
676314-7631487.89189.60
20min180017-8001792.15590.651.8794.8193.321.85
276499-7649988.10490.72
379556-7955691.62494.31
477416-7741689.16091.78
580043-8004392.18594.89
678754-7875490.70193.38
30min180433-8043392.63492.862.8296.3196.532.72
277092-7709288.78792.38
380318-8031892.50296.21
484210-8421096.984100.60
580496-8049692.70796.43
681233-8123393.55697.25
45min182203-8220394.67393.221.9499.3897.921.90
278531-7853190.44495.02
382492-8249295.00699.74
479983-7998392.11696.81
582058-8205894.50699.26
680373-8037392.56597.30
极限181564-8156493.93793.322.0599.7099.052.01
277766-7776689.56395.15
381258-8125893.58599.37
481240-8124093.56499.28
582416-8241694.918100.73
681899-8189994.323100.08
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%
110.152062320637205932048420552205780.30
210.272063320762206980.45
单位质量响应值RSD%判断
2027.392015.380.43数据可信
供试品溶液-2022082101批-培哚普利-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min122997-2299797.06898.111.5197.0798.111.51
223347-2334798.54598.55
323603-2360399.62699.63
422682-2268295.73895.74
523278-2327898.25498.25
623551-2355199.40699.41
10min122889-2288996.61298.541.7397.6999.631.73
223538-2353899.352100.45
323795-23795100.436101.54
422803-2280396.24997.31
523560-2356099.444100.54
623494-2349499.166100.27
15min122680-2268095.73097.822.1697.88100.002.15
223329-2332998.469100.67
323705-23705100.056102.28
422442-2244294.72596.86
523369-2336998.638100.83
623523-2352399.288101.49
20min122316-2231694.19496.462.5197.4199.732.49
222645-2264595.58298.88
323473-2347399.077102.41
422148-2214893.48596.67
523061-2306197.338100.63
623475-2347599.086102.40
30min122571-2257195.27095.931.7099.53100.271.70
222794-2279496.211100.57
323291-2329198.309102.74
422150-2215093.49397.72
522610-2261095.43599.81
622944-2294496.844101.25
45min121926-2192692.54794.841.8697.87100.251.85
222790-2279096.194101.62
322798-2279896.228101.76
421962-2196292.69997.96
522567-2256795.253100.69
622776-2277696.135101.62
极限121830-2183092.14293.642.2698.49100.102.22
222065-2206593.13499.63
322642-2264295.570102.17
421420-2142090.41296.70
522656-2265695.629102.12
622492-2249294.937101.49
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%
114.528229282119820398189381792820270.24
214.638179381849818210.05
单位质量响应值RSD%判断
5649.245592.690.72数据可信
供试品溶液-2022082101批-氨氯地平-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min145289-4528952.23264.8210.2352.2364.8210.23
254812-5481263.21563.21
359076-5907668.13368.13
458235-5823567.16367.16
561380-6138070.79070.79
658423-5842367.37967.38
10min164962-6496274.92182.554.9775.5083.275.01
271040-7104081.93182.63
373575-7357584.85485.61
472148-7214883.20983.95
575309-7530986.85487.64
672444-7244483.55084.30
15min169220-6922079.83287.394.7881.2489.034.82
276265-7626587.95789.57
378613-7861390.66592.36
474187-7418785.56087.23
578338-7833890.34792.10
678043-7804390.00791.68
20min170105-7010580.85288.004.7683.1590.604.79
275393-7539386.95189.54
380306-8030692.61795.32
475139-7513986.65889.28
578268-7826890.26793.02
678594-7859490.64393.32
30min169841-6984180.54889.695.2383.7593.285.24
278382-7838290.39893.95
380810-8081093.19896.93
477594-7759489.48993.07
579982-7998292.24396.00
680014-8001492.28095.96
45min171733-7173382.73090.954.9386.8295.544.96
279932-7993292.18696.75
382068-8206894.64999.42
477369-7736989.23093.81
581881-8188194.43499.22
680196-8019692.49097.20
极限170674-7067481.50990.035.3586.5295.635.36
277576-7757689.46995.05
381275-8127593.73599.56
476534-7653488.26793.84
581624-8162494.13799.97
680716-8071693.09098.83
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