缬沙坦氨氯地平片项目信息
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%
114.232459502463702462232463572461872462170.07
214.202453842456142454990.07
单位质量响应值RSD%判断
17302.6717288.660.06数据可信
稳定性考察-加速3月-供试品溶液-2023112221批-缬沙坦-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%
5min120835-208357.8098.1231.877.818.1231.89
222942-229428.5998.60
334434-3443412.90612.91
416943-169436.3506.35
514761-147615.5335.53
620001-200017.4967.50
10min156952-5695221.34623.9018.0421.3623.9118.06
266400-6640024.88724.90
384803-8480331.78531.81
458493-5849321.92421.93
552027-5202719.50019.51
663908-6390823.95323.97
15min185164-8516431.92036.8310.0831.9736.8910.10
299869-9986937.43137.49
3114437-11443742.89242.97
496169-9616936.04536.09
592163-9216334.54334.58
6101839-10183938.17038.22
20min1106706-10670639.99446.589.4640.1046.709.46
2116040-11604043.49243.61
3139781-13978152.39152.54
4129667-12966748.60048.71
5122798-12279846.02546.12
6130726-13072648.99749.11
30min1132459-13245949.64659.6111.1949.8159.8011.19
2141033-14103352.86053.05
3176233-17623366.05366.29
4168137-16813763.01963.21
5166508-16650862.40862.58
6169932-16993263.69163.89
45min1157092-15709258.87970.4311.7059.1370.7211.68
2162787-16278761.01361.29
3206360-20636077.34577.69
4196874-19687473.78974.08
5200371-20037175.10075.38
6203939-20393976.43776.74
60min1165926-16592662.19076.9912.5962.5477.4012.57
2179122-17912267.13667.52
3222066-22206683.23283.70
4220136-22013682.50882.92
5224225-22422584.04184.45
6221039-22103982.84783.28
极限1224428-22442884.11788.994.5784.5789.534.59
2223777-22377783.87384.37
3246914-24691492.54593.16
4238300-23830089.31689.87
5247572-24757292.79193.34
6243537-24353791.27991.85
缬沙坦氨氯地平片项目信息
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DZP67822106602对照品来源自制对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数200
标示量(mg)80供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.934636037463832746367174637047463870146373660.03
216.074637363464261546399890.09
单位质量响应值RSD%判断
291108.98288736.090.58数据可信
稳定性考察-加速3月-供试品溶液-2023112221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%
5min11494596-149459628.88229.3821.1328.8829.3821.13
21569821-156982130.33630.34
32116435-211643540.89940.90
41332313-133231325.74625.75
51185452-118545222.90822.91
61422161-142216127.48227.48
10min12618911-261891150.60953.5711.0550.6653.6211.06
22832770-283277054.74254.79
33340259-334025964.54964.62
42698973-269897352.15652.20
52442870-244287047.20747.25
62699952-269995252.17552.22
15min13144766-314476660.77167.508.0760.9067.648.08
23392782-339278265.56465.71
33986035-398603577.02877.20
43566486-356648668.92069.05
53363445-336344564.99765.11
63504044-350404467.71467.85
20min13424126-342412666.16975.938.6166.4076.188.61
23680656-368065671.12771.38
34392020-439202084.87385.18
44094251-409425179.11979.36
53940131-394013176.14176.37
64044033-404403378.14978.39
30min13734852-373485272.17485.209.8572.5285.589.84
24004006-400400677.37577.74
34836472-483647293.46293.91
44628303-462830389.43989.82
54617111-461711189.22389.58
64632871-463287189.52889.90
45min13976337-397633776.84191.0210.0277.3091.5410.01
24257317-425731782.27082.77
35102585-510258598.60599.21
44928673-492867395.24495.77
55037894-503789497.35597.86
64956854-495685495.78896.31
60min14127333-412733379.75893.289.2880.3593.959.26
24404956-440495685.12385.76
35180606-5180606100.112100.88
45021548-502154897.03997.72
55172879-517287999.963100.63
65054569-505456997.67798.36
极限15000570-500057096.63399.552.2797.36100.382.31
25088704-508870498.33699.11
35312035-5312035102.652103.58
45109046-510904698.73099.58
55267086-5267086101.784102.61
65132113-513211399.175100.02
缬沙坦氨氯地平片项目信息
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%
114.232460992460932460062461632461012460920.03
214.202453362453302453330.01
单位质量响应值RSD%判断
17293.8917276.970.07数据可信
稳定性考察-加速3月-供试品溶液-2023112221批-缬沙坦-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%
5min118677-186777.0046.0057.687.006.0057.66
2-0.0000.00
311912-119124.4674.47
418281-182816.8566.86
519888-198887.4597.46
627181-2718110.19410.19
10min153774-5377420.16719.7125.8820.1819.7225.88
232998-3299812.37512.38
339812-3981214.93114.94
459294-5929422.23722.25
560467-6046722.67722.69
668987-6898725.87225.89
15min193149-9314934.93333.1217.8534.9833.1617.87
267065-6706525.15125.17
371669-7166926.87826.91
494044-9404435.26935.32
595477-9547735.80735.86
6108455-10845540.67440.73
20min1120250-12025045.09742.5914.5345.2042.6814.55
296327-9632736.12536.19
389807-8980733.68033.76
4122035-12203545.76645.87
5121433-12143345.54145.65
6131487-13148749.31149.44
30min1162882-16288261.08557.6712.2461.2657.8412.26
2140382-14038252.64752.77
3121801-12180145.67945.81
4161913-16191360.72260.91
5164441-16444161.67061.86
6171222-17122264.21364.42
45min1200857-20085775.32770.7611.0675.6171.0311.06
2185155-18515569.43869.65
3148304-14830455.61855.83
4199048-19904874.64874.93
5204257-20425776.60276.89
6194515-19451572.94873.27
60min1220787-22078782.80178.3610.5483.2178.7410.54
2212629-21262979.74280.07
3164450-16445061.67361.98
4217152-21715281.43881.85
5217573-21757381.59682.01
6220999-22099982.88183.32
极限1243910-24391091.47390.374.9192.0290.884.95
2239717-23971789.90090.36
3218363-21836381.89282.30
4243812-24381291.43691.98
5248125-24812593.05493.61
6251892-25189294.46695.04
缬沙坦氨氯地平片项目信息
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DZP67822106602对照品来源自制对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数200
标示量(mg)80供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.934650095465110146512424652555465151646513020.02
216.074648556464825646484060.01
单位质量响应值RSD%判断
291983.80289259.860.67数据可信
稳定性考察-加速3月-供试品溶液-2023112221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%
5min11303185-130318525.12321.5454.0425.1221.5454.03
2-0.0000.00
3977075-97707518.83618.84
41285455-128545524.78124.78
51363653-136365326.28926.29
61773043-177304334.18134.18
10min12527510-252751048.72547.8018.6248.7747.8418.64
21771888-177188834.15934.16
32127831-212783141.02041.05
42651208-265120851.11051.15
52731775-273177552.66352.71
63066832-306683259.12359.18
15min13378705-337870565.13563.2413.8265.2663.3613.85
22667732-266773251.42951.49
32792504-279250453.83453.93
43455240-345524066.61066.74
53570615-357061568.83568.97
63818291-381829173.60973.76
20min13931524-393152475.79273.2911.6676.0273.5111.68
23316494-331649463.93664.08
33193662-319366261.56861.76
43975809-397580976.64676.88
54107101-410710179.17779.42
64286981-428698182.64582.92
30min14573009-457300988.15984.9510.1588.5285.3010.17
24146084-414608479.92880.18
33620168-362016869.79070.08
44586169-458616988.41288.78
54701573-470157390.63791.02
64813602-481360292.79793.21
45min14963268-496326895.68292.539.1996.1993.029.20
24715849-471584990.91291.29
33945872-394587276.06976.48
44990272-499027296.20396.72
55060257-506025797.55298.08
65123843-512384398.77899.35
60min15105603-510560398.42695.548.3399.0996.188.34
24959177-495917795.60396.14
34134804-413480479.71180.25
45126388-512638898.82799.50
55183931-518393199.936100.63
65225719-5225719100.742101.48
极限15188732-5188732100.029100.212.70100.86101.012.77
25123656-512365698.77499.47
34975554-497555495.91996.59
45222945-5222945100.688101.53
55301182-5301182102.196103.05
65377190-5377190103.662104.56
缬沙坦氨氯地平片项目信息
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%
114.232460172460742459672459832458432459770.04
214.202455092454702454900.02
单位质量响应值RSD%判断
17285.8017288.030.01数据可信
稳定性考察-加速3月-供试品溶液-2023112421批-缬沙坦-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%
5min129899-2989911.21210.089.0011.2110.089.00
224735-247359.2769.28
329700-2970011.13711.14
424739-247399.2779.28
525156-251569.4339.43
627125-2712510.17210.17
10min173685-7368527.63226.213.5427.6526.233.54
268988-6898825.87025.89
371107-7110726.66526.68
466504-6650424.93924.95
568507-6850725.69025.71
670561-7056126.46026.48
15min1106093-10609339.78438.362.9439.8538.422.94
2100000-10000037.50037.56
3104965-10496539.36139.42
499265-9926537.22437.28
599694-9969437.38537.44
6103806-10380638.92738.99
20min1129374-12937448.51547.492.1248.6547.612.12
2123210-12321046.20346.32
3127184-12718447.69347.82
4123507-12350746.31546.43
5129015-12901548.38048.50
6127522-12752247.82047.95
30min1160256-16025660.09560.040.7560.3160.250.75
2160469-16046960.17560.37
3161876-16187660.70360.91
4158220-15822059.33259.53
5159612-15961259.85460.06
6160265-16026560.09960.30
45min1189596-18959671.09871.960.9771.4172.270.96
2192175-19217572.06572.36
3193876-19387672.70373.01
4193423-19342372.53372.83
5189689-18968971.13271.43
6192690-19269072.25872.56
60min1207465-20746577.79878.431.9078.2378.851.88
2208753-20875378.28178.70
3207707-20770777.88978.32
4212878-21287879.82880.24
5214458-21445880.42180.84
6203564-20356476.33676.76
极限1234296-23429687.86090.271.8188.4290.831.80
2241362-24136290.51091.06
3242103-24210390.78791.35
4242445-24244590.91691.46
5246788-24678892.54493.10
6237422-23742289.03289.59
缬沙坦氨氯地平片项目信息
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DZP67822106602对照品来源自制对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数200
标示量(mg)80供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.934657772465795146564254655908465437046564850.04
216.074663692466437946640360.02
单位质量响应值RSD%判断
292309.17290232.480.51数据可信
稳定性考察-加速3月-供试品溶液-2023112421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%
5min11833681-183368135.27133.035.4435.2733.035.44
21638082-163808231.50831.51
31822550-182255035.05735.06
41612751-161275131.02131.02
51676780-167678032.25332.25
61718289-171828933.05133.05
10min13133436-313343660.27158.542.0560.3358.602.06
22993798-299379857.58557.64
33061700-306170058.89258.95
42954056-295405656.82156.87
53057545-305754558.81258.87
63061193-306119358.88258.94
15min13800212-380021273.09772.201.2673.2672.351.27
23709645-370964571.35571.50
33729299-372929971.73371.89
43696286-369628671.09871.24
53790903-379090372.91873.07
63795348-379534873.00373.16
20min14202772-420277280.84080.741.0281.1281.011.02
24159588-415958880.00980.28
34157136-415713679.96280.24
44169414-416941480.19880.46
54255195-425519581.84882.12
64240608-424060881.56881.84
30min14639675-463967589.24489.960.7189.6690.360.70
24651380-465138089.46989.87
34652740-465274089.49589.90
44694381-469438190.29690.69
54717673-471767390.74491.15
64705366-470536690.50790.92
45min14923344-492334494.70095.470.9095.2696.020.89
24938177-493817794.98595.54
34931712-493171294.86195.42
45019159-501915996.54397.09
55019680-501968096.55397.11
64947416-494741695.16395.72
60min15015383-501538396.47097.231.0697.1997.941.06
25025436-502543696.66497.37
35019282-501928296.54597.26
45121753-512175398.51799.23
55125575-512557598.59099.31
65021080-502108096.58097.30
极限15157108-515710899.197100.391.31100.08101.271.30
25169702-516970299.439100.31
35169957-516995799.444100.32
45310618-5310618102.149103.02
55297410-5297410101.895102.78
65210950-5210950100.232101.11
缬沙坦氨氯地平片项目信息
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%
114.232449382449722450422450932450452450180.03
214.202443642444662444150.03
单位质量响应值RSD%判断
17218.4117212.320.03数据可信
稳定性考察-加速3月-供试品溶液-2023112421批-缬沙坦-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%
5min122481-224818.46510.3223.068.4710.3223.05
235400-3540013.33013.33
322731-227318.5598.56
426586-2658610.01110.01
522102-221028.3238.32
635220-3522013.26213.26
10min160404-6040422.74526.5912.7522.7626.6112.75
281602-8160230.72830.75
366024-6602424.86224.88
469558-6955826.19226.21
564549-6454924.30624.32
681616-8161630.73330.75
15min196589-9658936.37139.467.0536.4239.527.06
2116149-11614943.73643.81
3102501-10250138.59738.65
499844-9984437.59737.66
5102437-10243738.57338.63
6111171-11117141.86241.94
20min1120665-12066545.43748.455.7145.5548.585.73
2139818-13981852.64952.80
3126108-12610847.48647.61
4123091-12309146.35046.47
5127265-12726547.92248.04
6135106-13510650.87551.02
30min1164437-16443761.91962.233.9862.1162.443.98
2174989-17498965.89366.13
3166446-16644662.67662.88
4154398-15439858.13958.34
5166148-16614862.56462.76
6165218-16521862.21362.44
45min1197985-19798574.55274.192.1974.8474.502.17
2200229-20022975.39775.74
3199332-19933275.05975.36
4191370-19137072.06172.36
5201298-20129875.80076.10
6191976-19197672.28972.62
60min1218532-21853282.28980.222.7482.7080.652.71
2213694-21369480.46780.94
3215744-21574481.23981.67
4211748-21174879.73580.15
5216325-21632581.45881.89
6202128-20212876.11276.56
极限1243308-24330891.61990.301.1192.1790.871.11
2242911-24291191.46992.07
3237361-23736189.37989.94
4238620-23862089.85390.40
5237471-23747189.42189.99
6239201-23920190.07290.65
缬沙坦氨氯地平片项目信息
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DZP67822106602对照品来源自制对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数200
标示量(mg)80供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.934643015464290146458044645083464649246446590.04
216.074638114464007746390960.03
单位质量响应值RSD%判断
291566.79288680.520.71数据可信
稳定性考察-加速3月-供试品溶液-2023112421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%
5min11442007-144200727.84733.1315.9527.8533.1315.95
22009823-200982338.81238.81
31491149-149114928.79628.80
41775137-177513734.28034.28
51514874-151487429.25429.25
62059913-205991339.77939.78
10min12709056-270905652.31558.778.1152.3658.828.11
23328889-332888964.28564.35
32924116-292411656.46856.52
43121432-312143260.27960.34
52880040-288004055.61755.67
63295723-329572363.64463.71
15min13538650-353865068.33672.634.3968.4772.784.41
23985652-398565276.96877.14
33707256-370725671.59271.73
43798873-379887373.36173.52
53641223-364122370.31670.46
63893404-389340475.18675.36
20min14063569-406356978.47281.032.6778.7281.312.68
24365058-436505884.29584.59
34173764-417376480.60080.86
44254126-425412682.15282.43
54089287-408928778.96979.23
64231510-423151081.71682.01
30min14653414-465341489.86390.171.5490.2490.581.54
24754483-475448391.81592.26
34683921-468392190.45290.85
44740491-474049191.54591.96
54571908-457190888.28988.68
64611486-461148689.05389.49
45min15001659-500165996.58895.651.6997.1296.201.68
24985602-498560296.27896.87
34994738-499473896.45497.00
45038557-503855797.30197.87
54862028-486202893.89294.43
64834532-483453293.36193.94
60min15100508-510050898.49797.381.7199.1998.101.70
25066973-506697397.84998.60
35079913-507991398.09998.81
45135353-513535399.17099.90
54948594-494859495.56396.26
64923812-492381295.08595.82
极限15186938-5186938100.166100.112.05101.02101.002.04
25228111-5228111100.961101.88
35213405-5213405100.677101.55
45341754-5341754103.156104.05
55042474-504247497.37698.23
65092651-509265198.34599.24
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