阿齐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%
110.302845612846402848752847612848002847270.05
210.332845852848182847020.06
单位质量响应值RSD%判断
27643.4027560.700.22数据可信
供试品溶液-20220127批-阿齐沙坦-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%
5min13132-31321.0181.9232.791.021.9232.75
26511-65112.1172.12
34971-49711.6161.62
44825-48251.5691.57
57712-77122.5072.51
68210-82102.6692.67
10min18685-86852.8233.9216.002.833.9315.98
212834-128344.1724.18
313204-132044.2924.30
413288-132884.3204.33
510789-107893.5073.52
613525-135254.3974.41
15min118828-188286.1216.765.086.146.805.15
220889-208896.7916.83
321448-214486.9727.01
421793-217937.0857.12
520574-205746.6886.72
621266-212666.9136.95
20min125187-251878.1888.432.228.248.492.28
225873-258738.4118.48
326396-263968.5818.65
426712-267128.6848.76
525415-254158.2628.33
625915-259158.4258.50
30min131364-3136410.19610.211.8110.3010.331.78
231083-3108310.10510.22
331677-3167710.29810.42
432332-3233210.51110.63
531421-3142110.21510.33
630650-306509.96410.09
45min136201-3620111.76811.732.5111.9311.902.47
235296-3529611.47411.65
337068-3706812.05012.23
437108-3710812.06312.24
535844-3584411.65211.83
634913-3491311.35011.53
60min139613-3961312.87812.703.0813.1012.943.01
238554-3855412.53312.77
340317-4031713.10613.35
439871-3987112.96113.21
539028-3902812.68712.93
636955-3695512.01412.26
极限142542-4254213.83013.592.7014.1213.902.64
241318-4131813.43213.74
342410-4241013.78714.10
443014-4301413.98314.30
541725-4172513.56413.87
639865-3986512.96013.27
阿齐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4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.937173271997718397160471757717860.21
214.987167971840717600.16
单位质量响应值RSD%判断
4808.174790.390.27数据可信
供试品溶液-20220127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%
5min18132-813210.98626.9397.4410.9926.9397.43
213632-1363218.41618.42
356086-5608675.76875.77
4-0.0000.00
521706-2170629.32329.32
620061-2006127.10127.10
10min162965-6296585.06189.455.7985.1289.605.91
261965-6196583.71083.81
370552-7055295.31095.73
463445-6344585.70985.71
569780-6978094.26794.43
668591-6859192.66192.81
15min172814-7281498.36696.502.6198.9097.142.50
268919-6891993.10493.67
369376-6937693.72194.67
473321-7332199.05199.53
572525-7252597.97598.66
671637-7163796.77697.44
20min173182-7318298.86397.062.3299.9498.242.22
269436-6943693.80294.89
370388-7038895.08896.56
473809-7380999.710100.74
571926-7192697.16698.40
672348-7234897.73698.94
30min173037-7303798.66796.382.62100.3098.102.50
268910-6891093.09294.70
369261-6926193.56695.57
473312-7331299.038100.62
571975-7197597.23299.00
671571-7157196.68798.43
45min172062-7206297.35095.562.8299.5397.822.70
268029-6802991.90294.02
368862-6886293.02795.55
473368-7336899.114101.24
570879-7087995.75298.06
671238-7123896.23798.52
60min171705-7170596.86894.642.4399.5997.442.31
268023-6802391.89394.53
368335-6833592.31595.35
472186-7218697.517100.20
570298-7029894.96797.81
669810-6981094.30897.13
极限171712-7171296.87794.262.68100.1397.582.56
267471-6747191.14894.29
367980-6798091.83595.38
472054-7205497.339100.56
569765-6976594.24797.62
669689-6968994.14497.49
阿齐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%
110.302845612844422842842843072840092843210.08
210.332836722837232836980.02
单位质量响应值RSD%判断
27603.9827463.500.37数据可信
供试品溶液-20220127批-阿齐沙坦-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%
5min17946-79462.5901.8228.412.591.8228.29
25929-59291.9321.93
35703-57031.8591.86
44346-43461.4161.42
56206-62062.0222.02
63364-33641.0961.10
10min111112-111123.6214.2418.803.644.2518.75
213901-139014.5304.54
314856-148564.8414.85
414155-141554.6134.62
515071-150714.9124.92
68948-89482.9162.92
15min120411-204116.6527.077.056.697.117.05
222347-223477.2837.32
323373-233737.6177.65
421918-219187.1437.18
522801-228017.4317.47
619344-193446.3046.33
20min125721-257218.3828.564.898.458.634.95
226888-268888.7638.84
327734-277349.0389.12
426016-260168.4788.55
527112-271128.8368.92
624122-241227.8617.92
30min131641-3164110.31210.323.1410.4310.443.20
232009-3200910.43210.56
332996-3299610.75310.88
431493-3149310.26310.38
531941-3194110.40910.54
629947-299479.7609.86
45min136203-3620311.79811.743.1911.9711.923.24
236131-3613111.77511.96
337800-3780012.31912.51
435379-3537911.53011.71
536346-3634611.84512.03
634331-3433111.18811.34
60min139126-3912612.75112.742.9912.9912.983.04
239530-3953012.88313.13
340823-4082313.30413.56
438288-3828812.47812.72
539381-3938112.83413.09
637396-3739612.18712.40
极限141380-4138013.48513.582.1413.8013.892.21
242059-4205913.70714.03
343185-4318514.07414.41
441062-4106213.38213.69
541659-4165913.57613.90
640635-4063513.24313.53
阿齐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4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.937162871693716127190671583716840.19
214.987170471522716130.18
单位质量响应值RSD%判断
4801.344780.570.31数据可信
供试品溶液-20220127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%
5min1-0.00041.4766.010.0041.4766.01
217234-1723423.32223.32
341986-4198656.81856.82
449978-4997867.63467.63
550276-5027668.03768.04
624402-2440233.02233.02
10min156296-5629676.18389.528.4176.1889.758.54
265514-6551488.65888.79
372595-7259598.24098.56
467476-6747691.31391.69
569750-6975094.39094.77
665283-6528388.34588.53
15min172952-7295298.72396.312.9299.1597.032.85
271658-7165896.97297.59
373823-7382399.902100.76
468620-6862092.86193.74
570893-7089395.93796.84
669048-6904893.44094.11
20min173489-7348999.45096.053.34100.4297.323.24
272036-7203697.48498.64
373350-7335099.262100.68
468048-6804892.08793.49
570466-7046695.35996.79
668488-6848892.68393.88
30min173377-7337799.29995.703.12100.8297.503.01
271516-7151696.78098.48
372947-7294798.717100.68
468774-6877493.07094.98
569518-6951894.07696.04
668192-6819292.28293.99
45min171679-7167997.00194.293.1799.0896.623.09
270238-7023895.05197.29
372508-7250898.123100.64
467403-6740391.21493.64
569086-6908693.49295.98
667134-6713490.85093.07
60min171877-7187797.26994.363.0799.8897.212.96
270982-7098296.05898.83
371873-7187397.263100.32
467106-6710690.81293.75
568912-6891293.25696.26
667599-6759991.47994.21
极限170694-7069495.66893.282.8898.8296.652.80
269754-6975494.39697.70
371258-7125896.431100.03
466406-6640689.86593.30
568510-6851092.71296.24
666945-6694590.59493.83
阿齐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%
110.302844282846692844092844652847102845360.05
210.332860172854742857460.14
单位质量响应值RSD%判断
27624.8527661.760.10数据可信
供试品溶液-555886批-阿齐沙坦-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%
5min14361-43611.4161.3031.141.421.3031.11
23485-34851.1311.13
33881-38811.2601.26
43312-33121.0751.08
56320-63202.0512.05
62747-27470.8920.89
10min112397-123974.0243.9810.834.033.9810.88
211064-110643.5913.60
313092-130924.2504.26
410740-107403.4863.49
514313-143134.6464.66
611910-119103.8663.87
15min121952-219527.1267.193.967.167.223.98
221106-211066.8516.88
322707-227077.3717.40
421494-214946.9777.00
523556-235567.6467.68
622110-221107.1777.20
20min127760-277609.0118.971.959.089.041.97
227283-272838.8568.92
327812-278129.0289.10
426785-267858.6948.76
528357-283579.2059.28
627773-277739.0159.08
30min133494-3349410.87210.830.7310.9910.950.78
233043-3304310.72610.84
333566-3356610.89611.02
433175-3317510.76910.88
533642-3364210.92011.05
633215-3321510.78210.90
45min137454-3745412.15812.200.6012.3412.380.57
238017-3801712.34012.51
337621-3762112.21212.39
437514-3751412.17712.35
537530-3753012.18212.37
637390-3739012.13712.31
60min139776-3977612.91112.930.5413.1613.180.57
239993-3999312.98213.22
339793-3979312.91713.17
439699-3969912.88613.13
540193-4019313.04713.31
639619-3961912.86013.10
极限140611-4061113.18213.330.7813.5013.650.75
241582-4158213.49713.81
341176-4117613.36613.69
441048-4104813.32413.64
540986-4098613.30413.64
640960-4096013.29613.61
阿齐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4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.937178171559718847133671621716360.30
214.987231771910721140.40
单位质量响应值RSD%判断
4798.124814.020.24数据可信
供试品溶液-555886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%
5min111058-1105814.91723.7155.6714.9223.7155.67
223794-2379432.09832.10
334389-3438946.39146.39
48816-881611.89311.89
515727-1572721.21621.22
611681-1168115.75815.76
10min150769-5076968.48881.6813.1768.5781.8113.20
270759-7075995.45495.63
365954-6595488.97289.23
455888-5588875.39375.46
554218-5421873.14173.26
665706-6570688.63888.73
15min167653-6765391.26495.212.5791.7395.802.61
273120-7312098.63999.35
369881-6988194.27095.02
471136-7113695.96396.45
570415-7041594.99095.51
671281-7128196.15996.74
20min170541-7054195.16096.052.1296.1397.172.10
273359-7335998.962100.22
368780-6878092.78594.06
471787-7178796.84197.86
571310-7131096.19897.25
671442-7144296.37697.49
30min169204-6920493.35795.451.9694.8697.101.93
271919-7191997.01998.83
368833-6883392.85694.65
471950-7195097.06198.62
571418-7141896.34397.93
671217-7121796.07297.72
45min169594-6959493.88395.662.6195.9097.842.58
273614-7361499.306101.65
368240-6824092.05694.36
471806-7180696.86798.96
571108-7110895.92598.05
671098-7109895.91298.10
60min169109-6910993.22994.932.0195.7797.641.96
271524-7152496.48699.38
368230-6823092.04394.86
471279-7127996.15698.79
571631-7163196.63199.29
670456-7045695.04697.76
极限168301-6830192.13994.442.4195.2097.682.38
271848-7184896.924100.36
367580-6758091.16694.50
471173-7117396.01399.18
570652-7065295.31098.50
670503-7050395.10998.35
阿齐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%
110.302846562849612847232849722847412848110.06
210.332841282842262841770.03
单位质量响应值RSD%判断
27651.5527509.870.37数据可信
供试品溶液-555886批-阿齐沙坦-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%
5min15124-51241.6671.5245.181.671.5245.07
24852-48521.5791.58
33674-36741.1951.20
43072-30720.9991.00
52761-27610.8980.90
68513-85132.7702.77
10min19393-93933.0563.1917.343.073.2017.24
211687-116873.8023.81
39090-90902.9572.96
410515-105153.4213.43
511164-111643.6323.64
66998-69982.2772.29
15min120154-201546.5576.4211.006.586.4410.95
221630-216307.0377.07
318446-184466.0016.02
421104-211046.8666.89
521099-210996.8646.89
615944-159445.1875.22
20min126196-261968.5238.475.948.598.535.96
227587-275878.9759.04
325475-254758.2888.34
426922-269228.7598.82
526754-267548.7048.77
623228-232287.5577.61
30min132588-3258810.60210.563.0810.7110.663.12
233603-3360310.93211.05
332396-3239610.54010.64
432853-3285310.68810.80
532632-3263210.61610.73
630600-306009.95510.05
45min137011-3701112.04111.972.0012.2112.142.03
237343-3734312.14912.33
337110-3711012.07312.23
436895-3689512.00312.17
537140-3714012.08312.25
635338-3533811.49711.65
60min139191-3919112.75012.731.8612.9912.961.89
240015-4001513.01813.27
339711-3971112.92013.15
439279-3927912.77913.02
538254-3825412.44512.68
638288-3828812.45712.67
极限140419-4041913.15013.121.7113.4613.421.73
240795-4079513.27213.59
341179-4117913.39713.70
440044-4004413.02813.34
540337-4033713.12313.43
639167-3916712.74313.03
阿齐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4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.937177371691715227203371844717730.27
214.987160071407715040.20
单位质量响应值RSD%判断
4807.304773.300.51数据可信
供试品溶液-555886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%
5min18716-871611.79717.3458.1311.8017.3458.14
222891-2289130.98230.98
311012-1101214.90414.90
410087-1008713.65213.65
520662-2066227.96527.97
63505-35054.7444.74
10min166832-6683290.45577.7723.7990.5277.8723.78
269764-6976494.42394.60
337292-3729250.47350.56
469266-6926693.74993.82
556295-5629576.19376.35
645331-4533161.35461.38
15min171408-7140896.64889.9110.9997.2290.4411.07
272447-7244798.05498.75
356834-5683476.92377.29
471396-7139696.63297.23
569091-6909193.51294.09
657396-5739677.68378.05
20min171287-7128796.48493.247.2997.5994.267.36
272593-7259398.25299.49
368172-6817292.26893.06
471967-7196797.40598.54
570150-7015094.94596.04
659157-5915780.06780.87
30min171269-7126996.46094.815.9498.1096.365.96
272069-7206997.54399.33
373928-73928100.059101.36
471277-7127796.47198.15
569732-6973294.38096.01
662033-6203383.95985.20
45min170252-7025295.08394.533.7997.2696.603.82
271035-7103596.14398.47
373144-7314498.998100.86
469720-6972094.36396.57
569817-6981794.49596.64
665109-6510988.12389.83
60min169990-6999094.72994.243.7897.4396.843.75
271049-7104996.16299.03
373563-7356399.565101.97
469581-6958194.17596.91
567421-6742191.25293.93
666161-6616189.54691.75
极限169803-6980394.47694.862.3097.7197.982.17
270308-7030895.15998.56
373064-7306498.889101.85
469203-6920393.66496.92
568319-6831992.46795.65
669820-6982094.49997.20
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