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%
114.729060991101909539092590283907740.37
214.799161291369914900.19
单位质量响应值RSD%判断
6166.716185.940.23数据可信
长期12月-供试品溶液-2025021221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%
5min151985-5198554.56255.666.1054.5655.666.10
258596-5859661.50161.50
354814-5481457.53257.53
451879-5187954.45154.45
551511-5151154.06554.06
649380-4938051.82851.83
10min175972-7597279.73882.985.2179.8383.085.21
286452-8645290.73890.84
378422-7842282.31082.41
475286-7528679.01879.11
580857-8085784.86684.96
677395-7739581.23281.32
15min182045-8204586.11389.114.9986.3489.344.99
291286-9128695.81296.07
384115-8411588.28588.52
479377-7937783.31283.53
587978-8797892.34092.57
684611-8461188.80689.03
20min183732-8373287.88390.724.1088.2591.104.10
291777-9177796.32796.74
386825-8682591.13091.51
481985-8198586.05086.41
588860-8886093.26593.65
685444-8544489.68090.05
30min184552-8455288.74490.873.6789.2691.403.68
291162-9116295.68296.26
385753-8575390.00490.54
483045-8304587.16287.67
589776-8977694.22794.77
685182-8518289.40589.92
45min183248-8324887.37591.643.8288.0492.323.82
292307-9230796.88397.62
387853-8785392.20892.89
484208-8420888.38389.03
589290-8929093.71794.41
686948-8694891.25991.93
极限186680-8668090.97793.655.0191.7894.485.00
297032-97032101.843102.74
388705-8870593.10393.94
484733-8473388.93489.73
591507-9150796.04496.90
686683-8668390.98091.80
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%
112.113670733689933684033673063679733679500.22
212.203721453716143718800.11
单位质量响应值RSD%判断
30383.9830481.970.23数据可信
长期12月-供试品溶液-2025021221批-阿托伐他汀钙-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%
5min1246892-24689267.15266.352.8167.1566.352.81
2253775-25377569.02469.02
3234144-23414463.68563.68
4240366-24036665.37765.38
5241059-24105965.56565.57
6247438-24743867.30067.30
10min1309550-30955084.19483.724.0584.3183.834.05
2318366-31836686.59286.71
3287983-28798378.32878.43
4298570-29857081.20881.32
5311361-31136184.68784.80
6320900-32090087.28187.39
15min1317596-31759686.38386.323.8286.6386.573.82
2325631-32563188.56888.83
3298991-29899181.32281.56
4307246-30724683.56783.81
5323700-32370088.04388.29
6330968-33096890.02090.28
20min1319046-31904686.77786.663.9387.1787.053.93
2327785-32778589.15489.56
3299731-29973181.52381.90
4308367-30836783.87284.26
5323430-32343087.96988.37
6333231-33323190.63591.04
30min1321379-32137987.41287.143.5687.9587.683.56
2327370-32737089.04189.60
3301514-30151482.00882.52
4313400-31340085.24185.76
5325285-32528588.47489.02
6333417-33341790.68691.24
45min1323565-32356588.00687.753.5388.6988.433.53
2330569-33056989.91190.62
3304207-30420782.74183.39
4315071-31507185.69686.36
5326433-32643388.78689.48
6335788-33578891.33192.04
极限1324920-32492088.37588.364.0189.2189.204.01
2338952-33895292.19193.04
3304605-30460582.84983.63
4315613-31561385.84386.65
5328534-32853489.35890.20
6336680-33668091.57392.44
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%
114.729210492527919659228891883921530.29
214.799135191931916410.45
单位质量响应值RSD%判断
6260.396196.150.73数据可信
长期12月-供试品溶液-2025021221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%
5min152644-5264454.79454.553.6354.7954.553.63
253244-5324455.41955.42
352498-5249854.64254.64
453190-5319055.36355.36
548725-4872550.71550.72
654179-5417956.39256.39
10min176326-7632679.44479.574.2779.5479.664.27
277022-7702280.16880.26
373386-7338676.38476.47
475766-7576678.86178.95
573765-7376576.77876.86
682437-8243785.80485.90
15min181385-8138584.70986.213.7484.9386.433.73
282297-8229785.65985.88
381447-8144784.77484.99
482646-8264686.02286.25
580276-8027683.55583.77
688905-8890592.53792.77
20min182978-8297886.36787.813.3986.7388.173.39
285167-8516788.64689.01
380958-8095884.26584.62
484696-8469688.15688.52
583038-8303886.43086.78
689342-8934292.99193.38
30min185636-8563689.13489.383.1589.6489.893.16
284144-8414487.58188.10
384600-8460088.05688.56
484690-8469088.14988.66
584853-8485388.31988.81
691300-9130095.02995.58
45min185963-8596389.47490.413.3290.1391.073.32
287134-8713490.69391.36
385647-8564789.14689.79
485858-8585889.36590.03
584140-8414087.57788.22
692406-9240696.18196.89
极限185919-8591989.42990.732.7890.2491.552.78
287826-8782691.41492.23
385950-8595089.46190.26
485856-8585689.36390.17
585640-8564089.13889.93
691831-9183195.58296.45
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%
112.113736813740983730193732533726063733310.16
212.203712623743213727920.59
单位质量响应值RSD%判断
30828.3230556.720.63数据可信
长期12月-供试品溶液-2025021221批-阿托伐他汀钙-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%
5min1237591-23759164.07764.311.9264.0864.311.92
2241738-24173865.19565.20
3241272-24127265.06965.07
4242611-24261165.43165.43
5230373-23037362.13062.13
6237074-23707463.93763.94
10min1292410-29241078.86179.751.9778.9779.851.97
2293464-29346479.14579.25
3299431-29943180.75580.86
4299279-29927980.71480.82
5286893-28689377.37377.48
6302700-30270081.63681.74
15min1302863-30286381.68082.661.8981.9282.901.89
2304300-30430082.06882.31
3310821-31082183.82684.07
4309084-30908483.35883.60
5298180-29818080.41780.65
6313835-31383584.63984.88
20min1304899-30489982.22983.421.7382.6083.801.73
2307493-30749382.92983.31
3313048-31304884.42784.81
4312732-31273284.34284.72
5301968-30196881.43981.81
6315673-31567385.13585.52
30min1308095-30809583.09184.181.6583.6084.701.65
2310611-31061183.77084.29
3316162-31616285.26785.79
4314110-31411084.71385.24
5305129-30512982.29182.79
6318738-31873885.96286.49
45min1309928-30992883.58684.501.5884.2485.161.58
2310789-31078983.81884.47
3317272-31727285.56686.23
4315109-31510984.98385.65
5306908-30690882.77183.41
6319993-31999386.30086.97
极限1308668-30866883.24684.801.7884.0385.601.78
2313392-31339284.52085.31
3319461-31946186.15786.96
4317258-31725885.56286.37
5307283-30728382.87283.65
6320591-32059186.46187.27
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%
114.729152391482917009154291958916410.22
214.799159491058913260.42
单位质量响应值RSD%判断
6225.616174.850.58数据可信
中间条件12月-供试品溶液-2025021221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%
5min152431-5243154.81955.183.6754.8255.183.67
254095-5409556.55956.56
349415-4941551.66651.67
452131-5213154.50554.51
554822-5482257.31957.32
653739-5373956.18756.19
10min173142-7314276.47380.464.6176.5680.554.61
280143-8014383.79383.89
373226-7322676.56176.65
476057-7605779.52179.61
581770-8177085.49485.59
677397-7739780.92281.02
15min179969-7996983.61187.053.7183.8387.283.71
286257-8625790.18690.42
380416-8041684.07984.29
482845-8284586.61886.84
587594-8759491.58391.82
682470-8247086.22686.45
20min180995-8099584.68488.424.2985.0488.804.29
288616-8861692.65293.04
381796-8179685.52185.88
483335-8333587.13087.50
589597-8959793.67894.07
683099-8309986.88487.26
30min182557-8255786.31789.763.9986.8290.283.99
288743-8874392.78593.32
383063-8306386.84687.34
485411-8541189.30189.81
591188-9118895.34195.89
684166-8416687.99988.52
45min182396-8239686.14989.924.1886.7990.594.18
289771-8977193.86094.55
383021-8302186.80287.44
485243-8524389.12589.79
591074-9107495.22295.93
684520-8452088.36989.03
极限184361-8436188.20390.944.8088.9991.764.79
291123-9112395.27396.12
384406-8440688.25089.04
485114-8511488.99189.80
593361-9336197.61398.48
683482-8348287.28488.10
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%
112.113738663725743738603724493739913733480.21
212.203739533712193725860.52
单位质量响应值RSD%判断
30829.7330539.840.67数据可信
中间条件12月-供试品溶液-2025021221批-阿托伐他汀钙-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%
5min1245066-24506666.11066.331.7166.1166.331.70
2242509-24250965.42065.42
3241938-24193865.26665.27
4243626-24362665.72165.72
5251705-25170567.90067.90
6250453-25045367.56367.56
10min1299502-29950280.79482.781.9780.9082.891.97
2305406-30540682.38782.50
3307224-30722482.87782.99
4304739-30473982.20782.32
5317843-31784385.74285.86
6306391-30639182.65382.77
15min1309580-30958083.51385.692.2783.7685.942.27
2318116-31811685.81686.06
3317438-31743885.63385.88
4313870-31387084.67084.92
5330930-33093089.27289.53
6316000-31600085.24585.50
20min1312165-31216584.21086.382.4484.5986.772.43
2321276-32127686.66887.06
3320351-32035186.41986.81
4315695-31569585.16385.55
5334606-33460690.26490.67
6317117-31711785.54685.94
30min1315438-31543885.09386.862.1885.6287.402.17
2322842-32284287.09187.62
3322538-32253887.00987.54
4318497-31849785.91886.45
5335028-33502890.37890.93
6317661-31766185.69386.23
45min1317564-31756485.66786.962.3786.3387.642.37
2322609-32260987.02887.71
3321493-32149386.72787.41
4316164-31616485.28985.96
5337109-33710990.93991.65
6319121-31912186.08786.76
极限1318150-31815085.82587.492.4686.6388.312.46
2324267-32426787.47588.30
3324516-32451687.54288.37
4318444-31844485.90486.72
5339605-33960591.61392.47
6320866-32086686.55887.38
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%
114.729163891089913819122591202913070.24
214.799195592192920740.19
单位质量响应值RSD%判断
6202.926225.420.26数据可信
中间条件12月-供试品溶液-2025021221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%
5min153466-5346655.77553.075.6155.7753.075.62
251493-5149353.71753.72
354262-5426256.60556.61
447894-4789449.96249.96
550914-5091453.11353.11
647235-4723549.27549.27
10min178465-7846581.85479.434.6681.9579.524.66
274349-7434977.56077.65
379119-7911982.53682.63
473083-7308376.23976.32
580141-8014183.60283.69
671685-7168574.78174.86
15min185396-8539689.08485.774.5689.3185.994.55
281036-8103684.53684.75
381472-8147284.99085.22
479418-7941882.84883.06
587947-8794791.74591.97
678055-7805581.42681.63
20min187577-8757791.35987.984.4991.7488.354.49
283859-8385987.48087.84
386949-8694990.70491.08
480278-8027883.74584.09
587981-8798191.78092.16
679406-7940682.83583.18
30min187863-8786391.65789.555.4492.1990.055.43
285056-8505688.72989.23
388151-8815191.95892.48
481746-8174685.27685.76
592505-9250596.50097.03
679710-7971083.15283.63
45min188388-8838892.20589.995.6892.8990.655.67
285953-8595389.66590.32
388802-8880292.63793.31
481156-8115684.66185.29
593068-9306897.08797.78
680222-8022283.68684.31
极限190589-9058994.50190.745.3295.3491.555.32
286851-8685190.60291.40
388926-8892692.76693.60
481907-8190785.44486.22
592486-9248696.48097.34
681145-8114584.64985.41
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%
112.113750163754563743733731803725733741200.33
212.203756783757473757120.02
单位质量响应值RSD%判断
30893.4830796.070.23数据可信
中间条件12月-供试品溶液-2025021221批-阿托伐他汀钙-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%
5min1236698-23669863.52062.353.7663.5262.353.75
2241855-24185564.90464.90
3237818-23781863.82063.82
4225334-22533460.47060.47
5233803-23380362.74362.74
6218588-21858858.66058.66
10min1298798-29879880.18579.283.6180.2979.383.61
2300420-30042080.62080.73
3299879-29987980.47580.58
4291602-29160278.25478.35
5305991-30599182.11582.22
6275811-27581174.01674.11
15min1308675-30867582.83582.193.6183.0782.433.61
2312063-31206383.74483.99
3309423-30942383.03683.28
4302054-30205481.05881.29
5318820-31882085.55885.80
6286666-28666676.92977.15
20min1310717-31071783.38382.723.4083.7683.103.39
2313167-31316784.04184.42
3312058-31205883.74384.12
4302980-30298081.30781.67
5320414-32041485.98686.37
6290196-29019677.87678.23
30min1310971-31097183.45183.483.6483.9783.993.64
2315702-31570284.72185.24
3314538-31453884.40984.93
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45min1312600-31260083.88983.853.7084.5484.503.70
2318645-31864585.51186.17
3316302-31630284.88285.54
4306399-30639982.22582.86
5327259-32725987.82288.50
6293512-29351278.76679.38
极限1314191-31419184.31684.143.8185.1184.933.81
2320109-32010985.90486.71
3316016-31601684.80585.61
4307967-30796782.64583.42
5329152-32915288.33089.15
6293860-29386078.86079.60
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