左氨氯地平片项目信息
介质体积(ml)500取样体积(ml)5补液体积(ml)5
对照品批号100546-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.5对照品水分(%)0对照品稀释倍数10000
标示量(mg)2.5供试品稀释倍数5系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.718825288453885568872888506884990.20
213.778809988094880960.01
单位质量响应值RSD%判断
6455.076397.680.64数据可信
供试品溶液-2024031811批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min178562-7856285.07084.152.9985.0784.153.00
280471-8047187.13787.14
376950-7695083.32583.32
479404-7940485.98285.98
576988-7698883.36683.37
673882-7388280.00380.00
10min184059-8405991.02392.360.9891.8793.200.96
285325-8532592.39493.26
385140-8514092.19393.03
484840-8484091.86892.73
586413-8641393.57294.41
685982-8598293.10593.91
15min183757-8375790.69690.370.7892.4692.130.76
282704-8270489.55591.35
382723-8272389.57691.33
483391-8339190.29992.08
584340-8434091.32793.10
683802-8380290.74492.48
20min182292-8229289.10988.521.5891.7891.191.53
281196-8119687.92390.61
379874-7987486.49189.14
481571-8157188.32991.01
581773-8177388.54791.23
683779-8377990.72093.36
30min181192-8119287.91887.621.6691.4891.171.61
280797-8079787.49091.06
379944-7994486.56790.08
483424-8342490.33593.90
579723-7972386.32889.90
680396-8039687.05690.60
45min178318-7831884.80684.670.7189.2489.100.67
278356-7835684.84789.29
377859-7785984.30988.69
477308-7730883.71288.18
578387-7838784.88189.31
678937-7893785.47689.89
60min176983-7698383.36183.391.0488.6588.660.97
275733-7573382.00787.30
376864-7686483.23288.46
476993-7699383.37188.68
577249-7724983.64988.93
678223-7822384.70389.97
极限176186-7618682.49782.541.5388.6288.651.40
275458-7545881.70987.82
378063-7806384.53090.59
475119-7511981.34287.48
575378-7537881.62387.74
677129-7712983.51989.64
左氨氯地平片项目信息
介质体积(ml)500取样体积(ml)5补液体积(ml)5
对照品批号100546-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.5对照品水分(%)0对照品稀释倍数10000
标示量(mg)2.5供试品稀释倍数5系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.718712487268873978761287615874030.25
213.778980589822898140.02
单位质量响应值RSD%判断
6375.136522.441.62数据可信
供试品溶液-2024031811批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min181878-8187888.36385.083.1288.3685.083.12
277077-7707783.18183.18
380911-8091187.31987.32
478656-7865684.88584.89
575185-7518581.14081.14
679295-7929585.57585.58
10min185368-8536892.12991.671.5293.0192.521.51
285937-8593792.74393.57
386082-8608292.90093.77
485205-8520591.95392.80
584463-8446391.15291.96
682589-8258989.13089.99
15min185301-8530192.05791.522.1893.8693.282.13
284239-8423990.91192.67
386696-8669693.56295.36
482030-8203088.52790.30
586792-8679293.66695.39
683736-8373690.36892.11
20min185029-8502991.76388.302.3294.4990.982.28
280635-8063587.02189.69
382885-8288589.44992.19
480729-8072987.12389.78
579859-7985986.18488.84
681763-8176388.23990.89
30min186248-8624893.07988.322.9196.7291.882.84
280482-8048286.85690.39
382144-8214488.65092.28
479939-7993986.27089.79
582152-8215288.65892.18
680077-8007786.41989.95
45min181116-8111687.54084.951.8792.1189.401.84
278029-7802984.20988.62
378903-7890385.15289.67
477593-7759383.73888.13
577105-7710583.21287.62
679545-7954585.84590.24
60min178233-7823384.42982.981.5389.8888.281.47
276044-7604482.06787.32
376165-7616582.19787.57
478509-7850984.72789.95
575873-7587381.88287.12
676518-7651882.57887.83
极限175485-7548581.46381.132.3387.7687.262.16
275204-7520481.16087.23
374250-7425080.13186.32
472805-7280578.57184.64
578129-7812984.31790.38
675176-7517681.13087.21
左氨氯地平片项目信息
介质体积(ml)500取样体积(ml)5补液体积(ml)5
对照品批号100546-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.5对照品水分(%)0对照品稀释倍数10000
标示量(mg)2.5供试品稀释倍数5系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.718737987140872518730187015872170.17
213.778731487366873400.05
单位质量响应值RSD%判断
6361.566342.770.21数据可信
供试品溶液-2024031812批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min182172-8217290.01790.573.2290.0290.583.23
285742-8574293.92893.93
385241-8524193.37993.38
478755-7875586.27486.27
583335-8333591.29191.29
680840-8084088.55888.56
10min188792-8879297.26995.631.8498.1796.541.83
287462-8746295.81296.75
387798-8779896.18097.11
484383-8438392.43993.30
586816-8681695.10596.02
688535-8853596.98897.87
15min186644-8664494.91693.882.5796.7995.742.56
287441-8744195.78997.69
386095-8609594.31596.21
481815-8181589.62691.41
587622-8762295.98897.85
684564-8456492.63894.49
20min185166-8516693.29792.282.2496.1295.082.23
286464-8646494.71997.57
385069-8506993.19196.03
480937-8093788.66491.35
583984-8398492.00294.83
683807-8380791.80894.59
30min182948-8294890.86790.411.8394.6294.141.85
284580-8458092.65596.46
382595-8259590.48194.25
479959-7995987.59391.16
582996-8299690.92094.66
682124-8212489.96593.66
45min181965-8196589.79088.782.3294.4593.402.30
282819-8281990.72695.46
380394-8039488.06992.74
477700-7770085.11889.56
582425-8242590.29494.95
680928-8092888.65493.25
60min180639-8063988.33886.911.5993.9092.431.61
280524-8052488.21293.85
378972-7897286.51292.07
477181-7718184.55089.85
579165-7916586.72392.28
679540-7954087.13492.62
极限178333-7833385.81284.782.0092.2691.161.99
278575-7857586.07792.60
378150-7815085.61192.03
475034-7503482.19888.34
578409-7840985.89592.32
675836-7583683.07689.43
左氨氯地平片项目信息
介质体积(ml)500取样体积(ml)5补液体积(ml)5
对照品批号100546-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.5对照品水分(%)0对照品稀释倍数10000
标示量(mg)2.5供试品稀释倍数5系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.718715787367871778737287053872250.17
213.778627086479863740.18
单位质量响应值RSD%判断
6362.146272.621.01数据可信
供试品溶液-2024031812批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min176089-7608983.81689.815.8083.8289.815.80
278006-7800685.92885.93
386939-8693995.76895.77
478557-7855786.53586.54
587054-8705495.89595.90
682541-8254190.92490.92
10min184905-8490593.52895.311.8494.3796.211.87
286590-8659095.38496.24
388749-8874997.76298.72
484808-8480893.42194.29
587913-8791396.84197.80
686186-8618694.93995.85
15min183028-8302891.46093.181.3593.2395.041.39
284066-8406692.60494.42
385105-8510593.74895.68
484246-8424692.80294.60
586434-8643495.21297.14
684682-8468293.28295.14
20min183016-8301691.44791.680.7194.1394.460.74
282816-8281691.22793.97
384396-8439692.96795.84
482940-8294091.36394.09
583043-8304391.47794.36
683140-8314091.58494.37
30min180538-8053888.71790.271.4592.3293.971.47
280985-8098589.21092.86
382619-8261991.01094.81
481237-8123789.48793.13
582801-8280191.21095.00
683507-8350791.98895.70
45min180761-8076188.96389.400.9293.4594.000.91
281197-8119789.44393.99
381362-8136289.62594.34
480427-8042788.59593.13
580702-8070288.89893.60
682509-8250990.88895.52
60min177011-7701184.83286.371.4190.2191.861.42
278313-7831386.26691.70
380170-8017088.31293.92
477619-7761985.50290.92
579023-7902387.04892.64
678284-7828486.23491.77
极限176617-7661784.39884.671.2590.6391.031.26
276651-7665184.43690.74
377859-7785985.76692.26
475206-7520682.84489.12
577628-7762885.51291.98
677209-7720985.05091.45
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