替米沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100374-202106对照品来源中检所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10000
标示量(mg)5供试品稀释倍数5系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 15.042946029335293012952329582294400.41
214.972943229505294680.18
单位质量响应值RSD%判断
1957.451968.470.40数据可信
供试品溶液-24A2941批-氨氯地平-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min122552-2255274.47786.6211.6974.4886.6211.69
228733-2873394.88994.89
328086-2808692.75292.75
427492-2749290.79190.79
522071-2207172.88872.89
628436-2843693.90893.91
10min129307-2930796.78595.473.5597.2095.963.56
229482-2948297.36397.89
329458-2945897.28397.80
428247-2824793.28493.79
527132-2713289.60290.01
629836-2983698.53299.05
15min129216-2921696.48495.191.8097.4496.201.83
228877-2887795.36596.43
329254-2925496.61097.67
428894-2889495.42196.44
527831-2783191.91092.81
628868-2886895.33596.40
20min129247-2924796.58795.441.6998.0796.981.71
228803-2880395.12096.72
328979-2897995.70297.29
428851-2885195.27996.83
528047-2804792.62494.04
629467-2946797.31398.91
30min127724-2772491.55793.241.5893.5895.311.62
228235-2823593.24595.37
328390-2839093.75695.88
428214-2821493.17595.26
527850-2785091.97393.90
628984-2898495.71897.86
45min127801-2780191.81192.720.7594.3495.310.78
227984-2798492.41695.06
328259-2825993.32495.97
428331-2833193.56296.16
527918-2791892.19894.64
628168-2816893.02395.69
60min127787-2778791.76592.081.0894.8195.191.06
227772-2777291.71594.87
327781-2778191.74594.91
427524-2752490.89694.02
528038-2803892.59495.55
628400-2840093.78996.98
极限126506-2650687.53590.272.3591.0993.892.30
226959-2695989.03192.70
328345-2834593.60897.28
427201-2720189.83093.45
527244-2724489.97293.44
627753-2775391.65395.36
替米沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源中检所对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数625
标示量(mg)80供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.159159229115079163449160399144879148600.22
211.099098699075449087060.19
单位质量响应值RSD%判断
82050.2281939.220.10数据可信
供试品溶液-24A2941批-替米沙坦-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min189803-898039.85711.127.749.8611.127.73
2104198-10419811.43711.44
3110719-11071912.15312.15
498487-9848710.81010.81
596443-9644310.58610.59
6108104-10810411.86611.87
10min1209136-20913622.95523.924.8523.0123.984.85
2213424-21342423.42623.49
3235371-23537125.83525.90
4215503-21550323.65423.71
5208478-20847822.88322.94
6225680-22568024.77124.84
15min1323767-32376735.53835.665.2635.7235.865.26
2320009-32000935.12535.32
3355535-35553539.02539.24
4325729-32572935.75335.94
5302987-30298733.25733.44
6321254-32125435.26235.47
20min1424822-42482246.63046.056.0947.0146.456.08
2407803-40780344.76245.15
3461356-46135650.64051.07
4411753-41175345.19545.59
5384483-38448342.20242.57
6427172-42717246.88847.29
30min1562060-56206061.69462.545.2562.3363.195.25
2551768-55176860.56461.20
3613382-61338267.32768.04
4561762-56176261.66162.30
5532707-53270758.47259.08
6597066-59706665.53666.20
45min1735134-73513480.69181.544.3181.6782.534.32
2709843-70984377.91578.89
3792540-79254086.99288.07
4743198-74319881.57682.56
5711164-71116478.06078.99
6765272-76527283.99985.02
60min1835128-83512891.66691.854.3693.1093.304.35
2796643-79664387.44288.85
3870848-87084895.58797.15
4809463-80946388.84990.29
5818921-81892189.88791.25
6889608-88960897.64699.14
极限1874056-87405695.93998.105.3097.88100.065.28
2853238-85323893.65495.55
3959916-959916105.363107.46
4858217-85821794.20196.13
5869219-86921995.40897.27
6947858-947858104.040106.07
替米沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100374-202106对照品来源中检所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10000
标示量(mg)5供试品稀释倍数5系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 15.042933529366295112952629442294360.29
214.972928229330293060.12
单位质量响应值RSD%判断
1957.181957.650.02数据可信
供试品溶液-24A2941批-氨氯地平-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%
5min127194-2719490.06088.0510.4490.0688.0510.44
220989-2098969.51169.51
327395-2739590.72690.73
427713-2771391.77991.78
527781-2778192.00492.00
628445-2844594.20394.20
10min127582-2758291.34590.325.3291.8590.815.34
224393-2439380.78481.17
327618-2761891.46591.97
428177-2817793.31693.83
528320-2832093.78994.30
627545-2754591.22391.75
15min127862-2786292.27391.054.8593.2892.044.88
224820-2482082.19883.03
327636-2763691.52492.54
428151-2815193.23094.26
528234-2823493.50594.54
628247-2824793.54894.58
20min127654-2765491.58490.454.0693.1091.954.10
225134-2513483.23884.53
327539-2753991.20392.72
428235-2823593.50895.05
527918-2791892.45894.01
627393-2739390.71992.27
30min127371-2737190.64789.653.5192.6891.653.57
225172-2517283.36485.12
327139-2713989.87891.91
427615-2761591.45593.52
527663-2766391.61493.68
627466-2746690.96193.01
45min125824-2582485.52387.123.1588.0689.623.20
224957-2495782.65284.87
326148-2614886.59689.12
426858-2685888.94891.52
526969-2696989.31591.89
627083-2708389.69392.25
60min125768-2576885.33885.934.1488.3588.914.09
224830-2483082.23184.91
326264-2626486.98089.99
424699-2469981.79784.87
527480-2748091.00794.08
626636-2663688.21291.27
极限126126-2612686.52387.172.8890.0190.632.92
225199-2519983.45386.59
325773-2577385.35488.85
426927-2692789.17692.70
527176-2717690.00193.58
626728-2672888.51792.06
替米沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源中检所对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数625
标示量(mg)80供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.159105719125469084709079179131009105210.26
211.099062359059689061020.03
单位质量响应值RSD%判断
81661.0881704.420.04数据可信
供试品溶液-24A2941批-替米沙坦-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%
5min157011-570116.2826.0315.146.286.0315.12
240894-408944.5064.51
359985-599856.6096.61
465243-652437.1897.19
552472-524725.7815.78
652882-528825.8275.83
10min1127205-12720514.01614.0510.5414.0514.0810.54
2109822-10982212.10012.13
3133981-13398114.76214.80
4149671-14967116.49116.53
5122460-12246013.49313.53
6121953-12195313.43713.47
15min1171919-17191918.94219.265.4019.0619.375.43
2160137-16013717.64417.74
3177141-17714119.51819.64
4189204-18920420.84720.98
5173172-17317219.08119.19
6177059-17705919.50919.62
20min1197210-19721021.72922.343.7921.9522.563.82
2192182-19218221.17521.37
3205860-20586022.68222.91
4214654-21465423.65123.90
5203207-20320722.39022.60
6203437-20343722.41522.63
30min1218762-21876224.10424.601.9524.4424.941.99
2217660-21766023.98224.29
3228450-22845025.17125.52
4227027-22702725.01425.39
5224479-22447924.73425.07
6223299-22329924.60424.94
45min1220028-22002824.24325.051.7824.7225.531.73
2230071-23007125.35025.79
3227974-22797425.11925.61
4226993-22699325.01125.53
5227289-22728925.04325.52
6231784-23178425.53926.02
60min1222710-22271024.53925.063.3625.1525.683.22
2231487-23148725.50626.09
3229009-22900925.23325.87
4214564-21456423.64124.30
5236073-23607326.01126.63
6230546-23054625.40226.02
极限1227093-22709325.02225.311.2725.7726.071.18
2232986-23298625.67126.39
3226455-22645524.95125.72
4227865-22786525.10725.89
5232161-23216125.58026.34
6231801-23180125.54026.30
替米沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100374-202106对照品来源中检所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10000
标示量(mg)5供试品稀释倍数5系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 15.042925029210293972925629277292780.25
214.972925629377293160.30
单位质量响应值RSD%判断
1946.681958.320.43数据可信
供试品溶液-24A2941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%
5min110602-1060235.20046.2019.0335.2046.2019.03
216188-1618853.74653.75
316573-1657355.02555.02
411304-1130437.53137.53
512909-1290942.86042.86
615919-1591952.85352.85
10min117563-1756358.31267.6212.0058.5167.8811.98
217627-1762758.52458.82
323263-2326377.23777.54
419726-1972665.49365.70
522381-2238174.30874.55
621641-2164171.85172.14
15min119836-1983665.85877.539.2466.3878.169.26
224909-2490982.70183.33
325445-2544584.48185.22
421659-2165971.91172.48
523991-2399179.65480.30
624262-2426280.55381.25
20min121313-2131370.76278.936.0271.6579.996.07
224769-2476982.23783.32
324991-2499182.97484.18
423073-2307376.60677.58
523630-2363078.45579.55
624861-2486182.54283.68
30min124258-2425880.54084.382.3981.8285.882.47
225301-2530184.00385.54
325584-2558484.94386.61
425611-2561185.03286.43
525904-2590486.00587.53
625837-2583785.78387.38
45min125384-2538484.27986.451.5686.0088.421.65
225829-2582985.75687.76
326081-2608186.59388.73
426149-2614986.81888.69
526194-2619486.96888.97
626598-2659888.30990.38
60min125675-2567585.24587.942.3387.4490.392.34
225894-2589485.97288.45
326827-2682789.07091.69
427310-2731090.67393.03
526428-2642887.74590.24
626779-2677988.91091.48
极限125505-2550584.68086.432.2887.3589.372.22
226085-2608586.60689.57
325731-2573185.43188.54
426968-2696889.53892.39
525460-2546084.53187.51
626450-2645087.81890.88
替米沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源中检所对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数625
标示量(mg)80供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.159054369054019046579034389047889047440.09
211.099032539029369030940.03
单位质量响应值RSD%判断
81142.9681433.180.26数据可信
供试品溶液-24A2941批-替米沙坦-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%
5min1191817-19181721.23826.0315.3421.2426.0315.34
2280335-28033531.03831.04
3253803-25380328.10028.10
4198092-19809221.93221.93
5224284-22428424.83224.83
6262338-26233829.04529.05
10min1372180-37218041.20747.4511.2941.3247.6011.28
2382212-38221242.31842.49
3484017-48401753.58953.75
4404593-40459344.79644.92
5473560-47356052.43152.57
6455102-45510250.38850.55
15min1512333-51233356.72470.4514.4357.0770.8614.39
2763212-76321284.50184.91
3693035-69303576.73177.19
4553190-55319061.24861.62
5636840-63684070.50970.94
6659106-65910672.97573.42
20min1649164-64916471.87484.199.2672.5484.999.28
2843201-84320193.35794.23
3800352-80035288.61389.49
4709039-70903978.50379.21
5764320-76432084.62485.44
6796599-79659988.19889.04
30min1852538-85253894.39198.033.2395.4599.293.23
2915656-915656101.379102.77
3849144-84914494.01595.39
4905319-905319100.235101.38
5885267-88526798.01599.31
6904342-904342100.127101.46
45min1884500-88450097.93098.302.7199.52100.112.68
2907497-907497100.476102.43
3850962-85096294.21796.11
4900010-90001099.647101.35
5870114-87011496.33798.17
6913716-913716101.165103.06
60min1865254-86525495.79998.432.8197.93100.792.78
2896072-89607299.211101.73
3863136-86313695.56497.98
4921115-921115101.984104.24
5874999-87499996.87899.25
6913680-913680101.161103.62
极限1859772-85977295.19296.633.8397.8599.533.76
2890463-89046398.590101.66
3833331-83333192.26495.21
4901894-90189499.856102.68
5838853-83885392.87695.78
6912048-912048100.980104.00
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