培哚普利氨氯地平片项目信息
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4000
标示量(mg)5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%
110.762253622644225312273022377225640.59
210.832250822718226130.66
单位质量响应值RSD%判断
2097.032088.000.31数据可信
供试品溶液-2022082001批-培哚普利-pH6.8磷酸盐溶液
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min122879-2287993.28784.685.9393.2984.685.93
221202-2120286.44986.45
320031-2003181.67581.67
421079-2107985.94885.95
519559-1955979.75079.75
619865-1986580.99881.00
10min123555-2355596.04491.763.2896.2091.913.28
222616-2261692.21592.36
321305-2130586.86987.01
422842-2284293.13693.28
522372-2237291.22091.35
622344-2234491.10691.24
15min123660-2366096.47292.092.9096.7992.392.90
222257-2225790.75191.05
321684-2168488.41588.70
422769-2276992.83993.14
522683-2268392.48892.77
622461-2246191.58391.87
20min123441-2344195.57992.252.2696.0692.702.27
222956-2295693.60194.05
322027-2202789.81390.24
422644-2264492.32992.78
522297-2229790.91491.35
622384-2238491.26991.71
30min122545-2254591.92591.230.9992.5691.831.00
222596-2259692.13392.74
322495-2249591.72192.30
422394-2239491.31091.92
522038-2203889.85890.45
622181-2218190.44191.03
45min121916-2191689.36189.452.2690.1590.202.25
222486-2248691.68592.44
321056-2105685.85486.58
421971-2197189.58590.34
521888-2188889.24689.99
622316-2231690.99291.73
极限122382-2238291.26189.811.5692.2090.711.57
222258-2225890.75591.67
321419-2141987.33488.21
422197-2219790.50691.41
521966-2196689.56590.45
621935-2193589.43890.33
培哚普利氨氯地平片项目信息
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4000
标示量(mg)5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%
113.988243082153819978206882150821600.21
213.988189682077819860.16
单位质量响应值RSD%判断
5876.975864.520.15数据可信
供试品溶液-2022082001批-氨氯地平-pH6.8磷酸盐溶液
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min150054-5005455.27048.0610.7355.2748.0610.73
245850-4585050.62850.63
341805-4180546.16146.16
446311-4631151.13751.14
537812-3781241.75241.75
639337-3933743.43643.44
10min171919-7191979.41373.235.6679.5173.315.66
266629-6662973.57273.66
361165-6116567.53967.62
468894-6889476.07376.16
564575-6457571.30471.37
664724-6472471.46971.54
15min177129-7712985.16679.134.8585.3979.334.86
271510-7151078.96279.17
366705-6670573.65673.85
473500-7350081.15981.37
570710-7071078.07878.27
670403-7040377.74077.93
20min178911-7891187.13481.375.0087.5081.705.00
276458-7645884.42584.76
368808-6880875.97876.29
474511-7451182.27682.62
571193-7119378.61278.93
672239-7223979.76780.09
30min179080-7908087.32184.213.2187.8384.673.22
279097-7909787.33987.82
376022-7602283.94484.38
476064-7606483.99084.47
573944-7394481.65082.10
673345-7334580.98881.44
45min178282-7828286.44083.265.2487.1083.885.23
280068-8006888.41289.04
368519-6851975.65976.24
475489-7548983.35683.98
574775-7477582.56783.15
675307-7530783.15583.74
极限178897-7889787.11987.251.6987.9288.001.70
280421-8042188.80189.57
376866-7686684.87685.58
480012-8001288.35089.11
578146-7814686.28987.01
679745-7974588.05588.78
培哚普利氨氯地平片项目信息
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4000
标示量(mg)5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%
110.762244722395222482222722264223160.45
210.832282622519226720.96
单位质量响应值RSD%判断
2073.982093.440.67数据可信
供试品溶液-2022082001批-培哚普利
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min119963-1996381.74383.184.0681.7483.184.06
219425-1942579.54079.54
320678-2067884.67084.67
421755-2175589.08089.08
520256-2025682.94282.94
619802-1980281.08381.08
10min122330-2233091.43592.160.9091.5792.300.90
222514-2251492.18892.32
322647-2264792.73392.87
422670-2267092.82792.98
522684-2268492.88493.02
622203-2220390.91591.05
15min122278-2227891.22292.022.7991.5192.322.79
221579-2157988.36088.65
322544-2254492.31192.61
423528-2352896.34096.64
522521-2252192.21792.51
622393-2239391.69391.98
20min122787-2278793.30692.372.4293.7592.812.42
221729-2172988.97489.41
322641-2264192.70893.16
423360-2336095.65296.12
522575-2257592.43892.88
622253-2225391.12091.56
30min122510-2251092.17290.922.4892.7791.522.47
221264-2126487.07087.65
321941-2194189.84290.45
422777-2277793.26593.89
522563-2256392.38992.99
622166-2216690.76391.35
45min122762-2276293.20491.631.5793.9592.381.56
222014-2201490.14190.87
322207-2220790.93191.68
422853-2285393.57694.35
522318-2231891.38692.14
622111-2211190.53891.28
极限122974-2297494.07290.422.8494.9891.332.83
221846-2184689.45390.33
321625-2162588.54889.45
422660-2266092.78693.72
522063-2206390.34291.25
621329-2132987.33688.23
培哚普利氨氯地平片项目信息
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4000
标示量(mg)5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%
113.988210782089818588193481735819450.20
213.988252281713821180.70
单位质量响应值RSD%判断
5861.595873.960.15数据可信
供试品溶液-2022082001批-氨氯地平
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min146415-4641551.27852.854.2651.2852.864.26
245433-4543350.19350.19
349274-4927454.43654.44
450263-5026355.52955.53
549410-4941054.58654.59
646257-4625751.10351.10
10min166151-6615173.08173.181.2873.1773.271.28
266419-6641973.37773.46
366077-6607773.00073.09
466810-6681073.80973.90
567233-6723374.27774.37
664766-6476671.55171.64
15min169523-6952376.80778.634.7577.0178.844.74
265678-6567872.55972.76
372619-7261980.22780.44
475759-7575983.69683.91
572145-7214579.70379.92
671320-7132078.79279.00
20min172160-7216079.72081.244.3080.0681.584.29
268690-6869075.88676.21
374802-7480282.63982.98
478298-7829886.50186.86
573925-7392581.67082.02
673326-7332681.00881.34
30min173665-7366581.38382.314.8581.8582.784.84
267999-6799975.12375.58
375453-7545383.35883.84
478639-7863986.87887.38
576526-7652684.54385.03
674720-7472082.54883.02
45min175991-7599183.95283.943.3984.5684.563.39
272161-7216179.72180.30
377205-7720585.29385.92
479981-7998188.36089.00
575120-7512082.99083.61
675447-7544783.35183.96
极限182306-8230690.92987.982.6391.6788.742.62
278020-7802086.19486.91
378770-7877087.02287.79
481409-8140989.93890.73
580444-8044488.87289.63
676885-7688584.94085.69
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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4000
标示量(mg)5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%
110.762239622250223372228922317223180.25
210.832241622559224880.45
单位质量响应值RSD%判断
2074.162076.450.08数据可信
供试品溶液-2022082101批-培哚普利
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min121002-2100286.34385.555.9086.3485.555.90
221949-2194990.23790.24
322301-2230191.68491.68
419663-1966380.83880.84
520763-2076385.36185.36
619182-1918278.86178.86
10min123158-2315895.20795.482.1695.3595.622.16
223760-2376097.68297.83
323920-2392098.34098.49
422770-2277093.61293.75
522950-2295094.35294.49
622787-2278793.68293.81
15min123027-2302794.66994.393.0894.9794.693.06
223787-2378797.79398.11
321642-2164288.97589.29
423139-2313995.12995.42
523100-2310094.96995.27
623059-2305994.80095.09
20min122758-2275893.56394.772.6194.0295.232.61
223781-2378197.76898.24
323743-2374397.61298.08
422998-2299894.54995.00
522781-2278193.65794.11
622256-2225691.49991.94
30min122136-2213691.00593.382.2091.6294.002.19
223479-2347996.52797.17
322327-2232791.79192.42
422568-2256892.78193.39
522682-2268293.25093.86
623097-2309794.95695.55
45min123156-2315695.19993.242.5395.9794.012.52
223178-2317895.28996.09
322701-2270193.32894.11
423087-2308794.91595.68
521920-2192090.11790.89
622032-2203290.57891.33
极限122352-2235291.89391.484.4492.8292.414.37
220609-2060984.72885.69
322129-2212990.97791.91
421908-2190890.06890.99
523195-2319595.35996.28
623316-2331695.85796.76
培哚普利氨氯地平片项目信息
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4000
标示量(mg)5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%
113.988201882006820508209681929820200.08
213.988217182178821740.01
单位质量响应值RSD%判断
5866.955877.970.14数据可信
供试品溶液-2022082101批-氨氯地平
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min141864-4186446.21347.315.9146.2147.315.92
243318-4331847.81847.82
346229-4622951.03151.03
439080-3908043.14043.14
544875-4487549.53749.54
641774-4177446.11446.11
10min161343-6134367.71670.033.4967.7970.113.49
265174-6517471.94572.02
366914-6691473.86573.95
461689-6168968.09868.17
563475-6347570.06970.15
662043-6204368.48868.57
15min168010-6801075.07576.773.8475.2776.963.83
274096-7409681.79381.99
366083-6608372.94873.16
469272-6927276.46876.65
570275-7027577.57577.77
669531-6953176.75476.95
20min171624-7162479.06580.503.5879.3880.823.57
276127-7612784.03584.37
376085-7608583.98984.32
472552-7255280.08980.40
571203-7120378.60078.93
669934-6993477.19977.52
30min172084-7208479.57282.242.8180.0282.702.80
278145-7814586.26386.74
372998-7299880.58181.05
474087-7408781.78382.23
574891-7489182.67183.13
674784-7478482.55383.00
45min179897-7989788.19784.503.6588.7885.093.63
279383-7938387.63088.25
376765-7676584.74085.34
476282-7628284.20684.79
574025-7402581.71582.31
672930-7293080.50681.09
极限178017-7801786.12286.994.8886.8587.734.82
273568-7356881.21181.98
377268-7726885.29586.04
477313-7731385.34586.07
583279-8327991.93092.66
683392-8339292.05592.77
培哚普利氨氯地平片项目信息
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4000
标示量(mg)5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%
110.762228922429224452250422370224070.37
210.832270822842227750.42
单位质量响应值RSD%判断
2082.432102.950.70数据可信
供试品溶液-2022082101批-培哚普利
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min118863-1886376.90776.965.8376.9176.965.83
219053-1905377.68277.68
320325-2032582.86882.87
419739-1973980.47980.48
517407-1740770.97170.97
617870-1787072.85872.86
10min121679-2167988.38885.462.2988.5285.592.30
220906-2090685.23785.37
321145-2114586.21186.35
421051-2105185.82885.96
520772-2077284.69084.81
620216-2021682.42382.54
15min121928-2192889.40387.982.2889.6888.252.28
221883-2188389.22089.49
321876-2187689.19189.47
421863-2186389.13889.42
521128-2112886.14286.40
620793-2079384.77685.03
20min122163-2216390.36288.712.0490.7989.132.04
222233-2223390.64791.07
322028-2202889.81190.24
421545-2154587.84288.27
521415-2141587.31287.71
621166-2116686.29786.70
30min122561-2256191.98487.653.9692.5688.223.94
220094-2009481.92682.50
321976-2197689.59990.18
421877-2187789.19689.77
521195-2119586.41586.96
621285-2128586.78287.33
45min122866-2286693.22891.272.0493.9691.982.04
222821-2282193.04493.75
322247-2224790.70491.43
422645-2264592.32793.05
521821-2182188.96789.66
621921-2192189.37590.06
极限123238-2323894.74593.201.8195.6394.061.80
223445-2344595.58896.45
322663-2266392.40093.28
422747-2274792.74393.62
522757-2275792.78393.62
622307-2230790.94991.79
培哚普利氨氯地平片项目信息
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4000
标示量(mg)5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%
113.988224382293818708215082098821310.21
213.988198582351821680.32
单位质量响应值RSD%判断
5874.895877.540.04数据可信
供试品溶液-2022082101批-氨氯地平
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min137394-3739441.25244.7312.4741.2544.7312.47
238012-3801241.93441.93
348615-4861553.63153.63
445118-4511849.77349.77
537849-3784941.75441.75
636301-3630140.04640.05
10min152717-5271758.15660.366.1758.2260.446.18
251667-5166756.99857.07
359658-5965865.81365.90
457399-5739963.32163.40
555525-5552561.25461.32
651343-5134356.64056.71
15min158500-5850064.53665.804.5864.7065.984.59
257262-5726263.17063.34
363825-6382570.41070.61
461331-6133167.65967.85
560376-6037666.60566.78
656571-5657162.40862.57
20min162069-6206968.47368.853.8968.7569.143.90
260079-6007966.27866.55
366323-6632373.16673.48
463347-6334769.88370.18
562953-6295369.44869.73
659696-5969665.85566.12
30min166070-6607072.88769.165.5273.2769.565.50
257136-5713663.03163.41
362453-6245368.89769.34
466192-6619273.02273.44
563668-6366870.23770.64
660656-6065666.91467.29
45min171205-7120578.55276.863.3179.0677.383.31
269302-6930276.45276.94
372290-7229079.74980.30
471212-7121278.56079.10
567601-6760174.57675.09
666435-6643573.29073.78
极限182985-8298591.54789.921.6692.1990.561.65
283051-8305191.62092.23
381598-8159890.01790.70
481104-8110489.47290.14
580745-8074589.07689.72
679575-7957587.78588.39
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