氨氯地平阿托伐他汀钙片项目信息
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2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.019226392499924499236092448924040.11
214.939133491272913030.05
单位质量响应值RSD%判断
6156.166115.410.47数据可信
供试品溶液-2025021021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%
5min167821-6782171.65468.0310.1971.6568.0310.18
270628-7062874.62074.62
364749-6474968.40968.41
453522-5352256.54756.55
569585-6958573.51873.52
660037-6003763.43063.43
10min181029-8102985.60987.621.7185.7387.731.71
285179-8517989.99390.12
383454-8345488.17188.28
482438-8243887.09787.19
583352-8335288.06388.19
682138-8213886.78086.89
15min186508-8650891.39793.571.8691.6693.831.86
291186-9118696.34096.61
388942-8894293.96994.23
487962-8796292.93493.17
589347-8934794.39794.67
687463-8746392.40692.66
20min189112-8911294.14996.281.7594.5696.701.76
292276-9227697.49297.93
393079-9307998.34098.76
489355-8935594.40594.80
591253-9125396.41196.84
691712-9171296.89697.30
30min189798-8979894.87397.541.7195.4498.121.71
294109-9410999.428100.03
393092-9309298.35498.94
491387-9138796.55297.10
593448-9344898.73099.32
692103-9210397.30997.87
45min190898-9089896.03698.421.4496.7799.161.44
294610-9461099.957100.72
394332-9433299.664100.41
492800-9280098.04598.76
593505-9350598.79099.54
692785-9278598.02998.76
极限191692-9169296.87498.181.1697.7699.081.16
294673-94673100.024100.95
393370-9337098.64799.56
491962-9196297.16098.04
592862-9286298.11199.03
693009-9300998.26699.16
氨氯地平阿托伐他汀钙片项目信息
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100590-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.423540193559393543003543633542433545730.22
211.513537163527583532370.20
单位质量响应值RSD%判断
31048.4230689.570.83数据可信
供试品溶液-2025021021批-阿托伐他汀钙-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%
5min169639-6963918.67416.8711.9318.6716.8711.91
267755-6775518.16918.17
358991-5899115.81915.82
450479-5047913.53613.54
569257-6925718.57218.57
661366-6136616.45616.46
10min1116305-11630531.18830.364.1931.2230.384.19
2116305-11630531.18831.22
3111119-11111929.79729.82
4107772-10777228.90028.92
5119235-11923531.97432.00
6108461-10846129.08429.11
15min1146831-14683139.37438.732.1539.4638.812.16
2145928-14592839.13139.21
3142466-14246638.20338.28
4139214-13921437.33137.40
5147393-14739339.52439.61
6144813-14481338.83238.91
20min1165769-16576944.45243.791.7044.6043.931.71
2164365-16436544.07544.22
3164625-16462544.14544.28
4158959-15895942.62642.76
5165283-16528344.32244.47
6160709-16070943.09543.24
30min1184727-18472749.53649.501.1049.7649.721.11
2183511-18351149.20949.43
3187278-18727850.22050.43
4181792-18179248.74948.95
5186508-18650850.01350.24
6183846-18384649.29949.51
45min1198183-19818353.14454.251.6653.4554.551.64
2200275-20027553.70554.01
3208133-20813355.81256.11
4202027-20202754.17554.46
5202109-20210954.19754.50
6203068-20306854.45454.75
极限1218081-21808158.48061.592.6058.8761.982.58
2230507-23050761.81262.20
3233687-23368762.66463.05
4229275-22927561.48161.86
5232711-23271162.40362.80
6233746-23374662.68063.07
氨氯地平阿托伐他汀钙片项目信息
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2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.019303993679934549322993166933130.28
214.939422194805945130.44
单位质量响应值RSD%判断
6216.726330.411.29数据可信
供试品溶液-2025021021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%
5min169105-6910571.41264.3911.0671.4164.3911.05
266065-6606568.27168.27
349609-4960951.26551.27
460509-6050962.52962.53
562800-6280064.89764.90
665780-6578067.97667.98
10min182882-8288285.64983.511.8385.7783.611.84
279580-7958082.23782.35
379255-7925581.90181.99
481259-8125983.97284.08
582045-8204584.78584.89
679822-7982282.48782.60
15min187913-8791390.84889.891.7391.1190.141.72
284833-8483387.66687.92
388866-8886691.83392.06
486724-8672489.62089.86
587798-8779890.73090.98
685764-8576488.62888.88
20min188809-8880991.77490.791.2492.1991.181.25
287653-8765390.58090.98
386172-8617289.04989.42
488310-8831091.25991.65
589034-8903492.00792.41
687140-8714090.05090.45
30min190034-9003493.04093.091.8693.6193.641.84
288374-8837491.32591.87
392820-9282095.91996.44
489725-8972592.72193.27
591014-9101494.05394.61
688507-8850791.46292.01
45min190709-9070993.73893.381.7294.4694.081.70
288455-8845591.40992.11
392237-9223795.31796.00
490420-9042093.43994.14
591702-9170294.76495.47
688658-8865891.61892.32
极限190760-9076093.79193.871.2994.6794.731.27
289821-8982192.82093.67
392513-9251395.60296.44
491764-9176494.82895.68
590773-9077393.80494.67
689394-8939492.37993.23
氨氯地平阿托伐他汀钙片项目信息
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100590-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.423588443597943596993581933578193588700.25
211.513627723646363637040.37
单位质量响应值RSD%判断
31424.6931598.960.40数据可信
供试品溶液-2025021021批-阿托伐他汀钙-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%
5min173519-7351919.31215.2717.1319.3115.2717.13
261170-6117016.06816.07
344099-4409911.58411.58
451345-5134513.48713.49
557926-5792615.21615.22
660658-6065815.93415.93
10min1125741-12574133.02928.638.8133.0628.658.82
2109386-10938628.73328.76
397622-9762225.64325.66
4102788-10278827.00027.02
5111596-11159629.31429.34
6106734-10673428.03728.06
15min1154424-15442440.56436.406.2740.6536.476.28
2136040-13604035.73535.81
3134078-13407835.21935.28
4130350-13035034.24034.31
5142155-14215537.34137.42
6134280-13428035.27235.35
20min1170811-17081144.86840.177.5945.0240.317.59
2154259-15425940.52040.65
3136736-13673635.91836.04
4146427-14642738.46338.59
5159248-15924841.83141.97
6150150-15015039.44139.57
30min1189125-18912549.67946.045.0449.9146.245.04
2168706-16870644.31544.52
3178950-17895047.00647.19
4164323-16432343.16443.35
5178447-17844746.87447.08
6171989-17198945.17845.38
45min1206056-20605654.12649.715.7354.4449.995.72
2178475-17847546.88247.16
3194079-19407950.98051.24
4178485-17848546.88447.14
5194140-19414050.99651.28
6184269-18426948.40348.68
极限1232472-23247261.06556.594.9461.4756.954.94
2206956-20695654.36354.72
3223198-22319858.62958.97
4204308-20430853.66754.01
5214472-21447256.33756.71
6211193-21119355.47655.83
氨氯地平阿托伐他汀钙片项目信息
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2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.019281592956926949291493231929220.22
214.939335893566934620.16
单位质量响应值RSD%判断
6190.676260.010.79数据可信
供试品溶液-2025021121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%
5min166980-6698069.74966.645.8069.7566.645.80
268288-6828871.11171.11
365669-6566968.38468.38
463610-6361066.24066.24
560675-6067563.18363.18
658751-5875161.18061.18
10min179503-7950382.79082.182.6382.9182.292.63
282408-8240885.81585.93
379513-7951382.80082.91
477311-7731180.50780.62
578161-7816181.39281.50
676580-7658079.74679.85
15min183957-8395787.42888.592.2687.6888.842.26
288323-8832391.97492.24
385526-8552689.06289.31
482954-8295486.38386.63
585780-8578089.32689.57
683906-8390687.37587.61
20min185503-8550389.03891.112.6189.4491.502.60
290009-9000993.73094.14
385465-8546588.99889.40
490217-9021793.94794.34
588156-8815691.80192.19
685588-8558889.12689.51
30min186714-8671490.29992.122.2890.8592.672.28
291719-9171995.51196.08
389324-8932493.01793.57
486542-8654290.12090.66
589258-8925892.94893.49
687232-8723290.83891.37
45min187936-8793691.57193.171.9692.2793.881.96
292146-9214695.95696.69
390199-9019993.92894.63
487331-8733190.94191.64
590208-9020893.93794.64
689027-8902792.70893.39
极限187825-8782591.45693.031.2792.3193.881.27
290567-9056794.31195.20
390161-9016193.88894.75
488085-8808591.72792.57
589901-8990193.61894.47
689477-8947793.17694.01
氨氯地平阿托伐他汀钙片项目信息
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100590-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.423600653603513585833593883601863597150.21
211.513615563618273616920.06
单位质量响应值RSD%判断
31498.6931424.150.17数据可信
供试品溶液-2025021121批-阿托伐他汀钙-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%
5min169041-6904118.16517.029.5618.1617.029.57
270717-7071718.60518.61
368186-6818617.94017.94
466345-6634517.45517.46
556453-5645314.85314.85
657401-5740115.10215.10
10min1108401-10840128.52028.285.7328.5528.315.73
2113714-11371429.91829.95
3113138-11313829.76629.80
4109677-10967728.85628.88
599053-9905326.06126.09
6100990-10099026.57026.60
15min1130845-13084534.42535.363.7034.5035.433.70
2142477-14247737.48537.57
3135042-13504235.52935.61
4137528-13752836.18336.26
5130096-13009634.22834.30
6130317-13031734.28634.36
20min1143951-14395137.87338.766.2838.0138.896.25
2160437-16043742.21142.35
3132565-13256534.87835.02
4148592-14859239.09439.23
5152100-15210040.01740.14
6146287-14628738.48838.61
30min1159224-15922441.89145.364.1242.0945.564.11
2178072-17807246.85047.06
3176085-17608546.32846.52
4175838-17583846.26346.47
5175822-17582246.25846.45
6169364-16936444.55944.75
45min1172484-17248445.38049.494.2845.6549.774.27
2192377-19237750.61450.91
3191378-19137850.35150.63
4191844-19184450.47450.75
5193996-19399651.04051.31
6186622-18662249.10049.36
极限1201230-20123052.94355.882.7953.2956.242.78
2218527-21852757.49457.87
3215696-21569656.74957.11
4212628-21262855.94256.31
5212724-21272455.96756.32
6213576-21357656.19156.54
氨氯地平阿托伐他汀钙片项目信息
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2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.019362493272937419365293435935450.21
214.939362893682936550.05
单位质量响应值RSD%判断
6232.186272.940.47数据可信
供试品溶液-2025021121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%
5min166705-6670569.15966.473.5569.1666.473.54
264807-6480767.19167.19
364595-6459566.97166.97
461030-6103063.27563.28
561696-6169663.96663.97
665841-6584168.26368.26
10min178618-7861881.51081.552.2481.6381.662.24
279484-7948482.40882.52
381465-8146584.46284.57
478768-7876881.66681.77
576911-7691179.74079.85
676689-7668979.51079.62
15min183557-8355786.63187.941.4986.8888.181.49
286104-8610489.27289.52
386638-8663889.82590.08
484559-8455987.67087.91
583905-8390586.99287.23
684134-8413487.22987.48
20min186515-8651589.69889.381.3390.0989.771.33
287712-8771290.93991.34
384242-8424287.34187.74
485919-8591989.08089.47
586151-8615189.32089.70
686689-8668989.87890.27
30min188238-8823891.48492.221.4792.0392.761.46
289811-8981193.11593.66
391216-9121694.57295.12
487928-8792891.16391.70
588155-8815591.39891.93
688321-8832191.57092.11
45min188640-8864091.90192.630.9192.6093.330.91
289964-8996493.27493.98
390686-9068694.02294.73
489066-8906692.34393.03
589012-8901292.28792.97
688705-8870591.96892.66
极限189815-8981593.11982.4731.7893.9783.3231.47
290725-9072594.06394.92
390036-9003693.34894.21
427959-2795928.98829.83
588826-8882692.09492.93
689919-8991993.22794.07
氨氯地平阿托伐他汀钙片项目信息
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100590-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.423613843594043608303607493606153605960.21
211.513632043629913630980.05
单位质量响应值RSD%判断
31575.8331546.310.07数据可信
供试品溶液-2025021121批-阿托伐他汀钙-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%
5min170355-7035518.45216.428.2618.4516.428.25
261660-6166016.17116.17
359314-5931415.55615.56
458740-5874015.40615.41
557918-5791815.19015.19
667594-6759417.72817.73
10min1109865-10986528.81427.383.4428.8427.403.43
2103620-10362027.17627.20
3105361-10536127.63327.66
4106213-10621327.85627.88
599828-9982826.18226.21
6101474-10147426.61326.64
15min1134508-13450835.27734.263.6935.3634.343.68
2129185-12918533.88133.95
3134737-13473735.33735.41
4135158-13515835.44735.52
5124801-12480132.73132.80
6125411-12541132.89132.97
20min1154407-15440740.49637.815.6740.6337.945.66
2144795-14479537.97538.10
3130817-13081734.30934.44
4150628-15062839.50539.64
5142285-14228537.31737.44
6141975-14197537.23537.36
30min1177022-17702246.42744.234.3546.6344.424.34
2163288-16328842.82543.02
3175504-17550446.02946.22
4173094-17309445.39745.59
5161709-16170942.41142.60
6161216-16121642.28242.47
45min1191703-19170350.27747.914.5350.5648.184.51
2176002-17600246.15946.42
3192280-19228050.42950.69
4185661-18566148.69348.97
5176397-17639746.26346.52
6174036-17403645.64445.91
极限1211160-21116055.38053.314.0355.7553.664.02
2205739-20573953.95854.30
3200181-20018152.50152.85
4213479-21347955.98856.34
5194152-19415250.92051.25
6194942-19494251.12751.46
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