阿齐沙坦左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100546-202105 对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数6250
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.455122451008512435115651112511490.19
212.435115950891510250.38
单位质量响应值RSD%判断
4108.354104.990.06数据可信
供试品溶液-24051501批-左氨氯地平-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%
5min139968-3996878.65483.354.3578.6583.344.35
240070-4007078.85578.86
344024-4402486.63686.64
443707-4370786.01386.01
543326-4332685.26385.26
643016-4301684.65384.65
10min145173-4517388.89891.213.3289.3391.673.32
244260-4426087.10187.54
348732-4873295.90196.38
446818-4681892.13592.61
546704-4670491.91092.38
646387-4638791.28791.76
15min145219-4521988.98891.673.3489.9292.643.35
244462-4446287.49888.42
348778-4877895.99297.01
447451-4745193.38094.37
546997-4699792.48793.47
646582-4658291.67092.65
20min145401-4540189.34691.743.3890.7793.223.38
244351-4435187.28088.69
348915-4891596.26297.81
447074-4707492.63994.15
547000-4700092.49393.99
646952-4695292.39893.89
30min145106-4510688.76691.763.4790.6993.753.47
244471-4447187.51689.41
348950-4895096.33098.41
446894-4689492.28494.31
547104-4710492.69894.71
647241-4724192.96794.97
45min145017-4501788.59191.633.4691.0194.133.46
244501-4450187.57589.95
348905-4890596.24298.86
447318-4731893.11995.65
546625-4662591.75594.28
647017-4701792.52695.04
60min143388-4338885.38591.134.0188.2994.143.98
244866-4486688.29391.16
348343-4834395.13698.29
447476-4747693.43096.48
547328-4732893.13896.18
646453-4645391.41694.45
极限147048-4704892.58795.683.2695.9799.203.27
246326-4632691.16794.52
350411-5041199.206102.89
449391-4939197.198100.77
549501-4950197.415100.97
649053-4905396.533100.07
阿齐沙坦左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68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20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%
111.053968053962183962233964103958703963050.09
211.153957733956033956880.04
单位质量响应值RSD%判断
35864.7135487.710.75数据可信
供试品溶液-24051501批-阿齐沙坦-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%
5min1116256-11625629.24130.6110.1329.2430.6110.14
2106890-10689026.88526.88
3129854-12985432.66132.66
4135199-13519934.00534.01
5132412-13241233.30433.30
6109570-10957027.55927.56
10min1293222-29322273.75176.513.4273.9176.683.43
2294177-29417773.99174.14
3320439-32043980.59780.78
4304693-30469376.63676.83
5311023-31102378.22878.41
6301535-30153575.84275.99
15min1329191-32919182.79884.162.8883.3784.762.87
2341058-34105885.78386.34
3350490-35049088.15588.78
4323657-32365781.40682.02
5332909-33290983.73384.35
6330371-33037183.09583.67
20min1335098-33509884.28485.703.4085.3286.763.38
2352347-35234788.62289.66
3357300-35730089.86890.99
4327176-32717682.29183.36
5334738-33473884.19385.28
6337595-33759584.91285.95
30min1345268-34526886.84287.543.1288.3489.083.09
2360491-36049190.67092.20
3360651-36065190.71192.33
4335108-33510884.28685.81
5338061-33806185.02986.58
6348594-34859487.67889.19
45min1350141-35014188.06788.623.3790.0590.643.32
2369518-36951892.94194.97
3363989-36398991.55093.67
4341476-34147685.88887.88
5341116-34111685.79787.82
6347688-34768887.45089.45
60min1353583-35358388.93389.332.9291.4191.842.89
2371693-37169393.48896.04
3363056-36305691.31693.95
4345151-34515186.81289.28
5345917-34591787.00589.51
6351480-35148088.40490.88
极限1402541-402541101.24799.821.49104.21102.831.46
2405187-405187101.912104.98
3395338-39533899.435102.57
4394900-39490099.325102.28
5389390-38939097.939100.92
6393754-39375499.037102.01
阿齐沙坦左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100546-202105 对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数6250
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.455088950821508895087450971508890.11
212.435113950913510260.32
单位质量响应值RSD%判断
4087.474105.070.31数据可信
供试品溶液-24051502批-左氨氯地平-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%
5min142092-4209283.04584.962.6383.0584.962.63
242163-4216383.18583.19
342380-4238083.61383.61
442771-4277184.38584.38
544459-4445987.71587.71
644526-4452687.84787.85
10min147079-4707992.88492.452.9793.3592.922.96
246744-4674492.22392.69
346141-4614191.03391.50
444627-4462788.04688.52
548107-4810794.91295.40
648452-4845295.59396.08
15min147437-4743793.59093.493.6594.5794.483.64
246832-4683292.39793.37
345817-4581790.39491.36
445614-4561489.99490.95
548411-4841195.51296.53
650209-5020999.059100.08
20min147729-4772994.16793.843.8795.6695.343.85
247133-4713392.99194.48
346755-4675592.24593.72
444797-4479788.38289.84
548767-4876796.21497.76
650197-5019799.036100.61
30min147509-4750993.73293.523.6895.7595.543.67
246720-4672092.17694.18
346399-4639991.54293.53
445031-4503188.84490.79
548952-4895296.57998.66
649788-4978898.229100.35
45min147138-4713893.00093.514.3095.5496.054.27
247099-4709992.92495.44
346295-4629591.33793.83
444568-4456887.93090.37
548822-4882296.32398.94
650448-5044899.531102.20
60min147375-4737593.46892.764.4696.5395.834.42
247230-4723093.18296.21
344776-4477688.34091.34
444470-4447087.73790.67
548303-4830395.29998.45
649954-4995498.556101.77
极限148828-4882896.33597.243.4599.91100.823.44
248856-4885696.39099.94
348235-4823595.16598.66
447855-4785594.41597.83
549367-4936797.398101.08
652583-52583103.743107.51
阿齐沙坦左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68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20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%
111.053951313950883947523950973950553950250.04
211.153970793969533970160.03
单位质量响应值RSD%判断
35748.8735606.820.29数据可信
供试品溶液-24051502批-阿齐沙坦-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%
5min1124413-12441331.29028.9411.0231.2928.9411.03
2115770-11577029.11629.12
3111506-11150628.04428.04
4123714-12371431.11431.11
5123518-12351831.06531.06
691467-9146723.00423.00
10min1302277-30227776.02374.674.4076.2074.834.41
2300222-30022275.50675.67
3286630-28663072.08872.24
4295438-29543874.30374.48
5317138-31713879.76179.93
6279716-27971670.34970.48
15min1325190-32519081.78682.961.6482.3883.541.63
2327124-32712482.27282.85
3334012-33401284.00584.56
4324609-32460981.64082.23
5338254-33825485.07185.69
6329946-32994682.98283.50
20min1329779-32977982.94085.002.3383.9986.042.31
2336560-33656084.64585.68
3347565-34756587.41388.44
4329085-32908582.76583.80
5346301-34630187.09588.18
6338609-33860985.16186.14
30min1334070-33407084.01986.531.9985.5388.041.97
2344579-34457986.66288.17
3352851-35285188.74390.25
4339066-33906685.27686.77
5349653-34965387.93889.51
6344138-34413886.55188.00
45min1338245-33824585.06988.042.0987.0590.022.05
2350082-35008288.04690.04
3358014-35801490.04192.04
4345532-34553286.90288.87
5351955-35195588.51790.58
6356403-35640389.63691.57
60min1342620-34262086.16988.481.3788.6290.951.35
2355167-35516789.32591.80
3354737-35473789.21791.72
4350763-35076388.21790.67
5352549-35254988.66791.22
6354896-35489689.25791.69
极限1384019-38401996.58198.371.6499.51101.341.58
2385070-38507096.84699.82
3396100-39610099.620102.62
4395601-39560199.494102.44
5387399-38739997.431100.48
6398704-398704100.275103.20
阿齐沙坦左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100546-202105 对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数6250
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.455117851271509435130651073511540.30
212.435090250825508640.11
单位质量响应值RSD%判断
4108.764092.040.29数据可信
供试品溶液-24051503批-左氨氯地平-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%
5min139054-3905476.97481.953.7476.9781.953.74
242817-4281784.39084.39
340326-4032679.48179.48
442484-4248483.73483.73
541935-4193582.65282.65
642854-4285484.46384.46
10min143250-4325085.24488.743.6685.6789.203.65
247714-4771494.04294.51
343354-4335485.44985.89
445082-4508288.85589.32
545163-4516389.01489.47
645593-4559389.86290.33
15min143756-4375686.24189.143.6287.1490.093.62
248004-4800494.61495.61
343474-4347485.68586.60
445114-4511488.91889.88
545160-4516089.00889.96
645857-4585790.38291.35
20min143608-4360885.94988.603.7187.3390.043.70
247512-4751293.64495.16
342761-4276184.28085.67
444889-4488988.47489.93
545189-4518989.06590.51
645746-4574690.16391.63
30min143840-4384086.40788.953.8088.2690.883.80
248172-4817294.94596.98
343203-4320385.15187.01
445020-4502088.73290.68
545173-4517389.03490.98
645368-4536889.41891.39
45min144569-4456987.84388.753.5490.1891.183.53
247773-4777394.15896.72
342822-4282284.40086.73
444859-4485988.41590.85
544949-4494988.59291.03
645215-4521589.11791.58
60min143376-4337685.49287.883.1488.3290.803.15
246920-4692092.47795.56
343068-4306884.88587.69
444769-4476988.23891.17
544197-4419787.11090.04
645198-4519889.08392.05
极限146337-4633791.32894.172.4194.6397.582.43
248669-4866995.92499.53
346347-4634791.34894.62
448162-4816294.92598.34
548230-4823095.05998.47
648935-4893596.44999.91
阿齐沙坦左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68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20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%
111.053962883964573959843963263959543962020.06
211.153940523942673941600.04
单位质量响应值RSD%判断
35855.3835350.671.01数据可信
供试品溶液-24051503批-阿齐沙坦-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%
5min1147533-14753337.18432.857.4237.1832.857.42
2126052-12605231.77031.77
3119996-11999630.24430.24
4133016-13301633.52633.53
5131336-13133633.10233.10
6124185-12418531.30031.30
10min1316113-31611379.67476.373.5079.8876.553.50
2315966-31596679.63779.81
3290573-29057373.23773.40
4296777-29677774.80074.99
5299831-29983175.57075.75
6298811-29881175.31375.49
15min1330626-33062683.33280.973.3683.9881.583.36
2338357-33835785.28085.90
3315593-31559379.54380.12
4310858-31085878.34978.95
5318008-31800880.15180.76
6314114-31411479.17079.76
20min1333887-33388784.15382.353.0285.2783.413.02
2342365-34236586.29087.38
3321835-32183581.11682.13
4315261-31526179.45980.50
5326162-32616282.20683.26
6320892-32089280.87881.91
30min1338705-33870585.36883.842.5386.9585.362.54
2345909-34590987.18488.76
3331984-33198483.67485.14
4322535-32253581.29282.77
5328828-32882882.87884.38
6327918-32791882.64984.13
45min1354897-35489789.44985.662.9091.5087.632.90
2348258-34825887.77689.83
3337717-33771785.11987.05
4328291-32829182.74384.67
5335450-33545084.54786.51
6334472-33447284.30186.24
60min1349932-34993288.19786.111.9290.7588.561.94
2347957-34795787.70090.24
3343442-34344286.56288.97
4333311-33331184.00886.40
5337711-33771185.11787.55
6337452-33745285.05287.46
极限1392346-39234698.88897.931.61101.93100.861.57
2384367-38436796.87799.91
3398850-398850100.527103.41
4381515-38151596.15899.01
5388268-38826897.860100.77
6385889-38588997.260100.14
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