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%
113.922531012529632528282526022524512527890.11
214.042525022526372525700.04
单位质量响应值RSD%判断
18160.1317989.320.67数据可信
供试品溶液-25010701批-氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1142028-14202850.94052.272.3550.9452.282.35
2147708-14770852.97752.98
3142628-14262851.15551.15
4143469-14346951.45651.46
5149031-14903153.45153.45
6149641-14964153.67053.67
10min1166742-16674259.80360.321.7359.8960.411.73
2170487-17048761.14761.23
3163780-16378058.74158.83
4166644-16664459.76859.85
5170416-17041661.12161.21
6171041-17104161.34561.43
15min1177529-17752963.67264.261.4363.8664.441.43
2180714-18071464.81565.00
3175459-17545962.93063.11
4178004-17800463.84364.03
5181984-18198465.27065.46
6181245-18124565.00565.20
20min1185868-18586866.66367.191.4066.9567.491.40
2188830-18883067.72668.02
3183160-18316065.69265.98
4186708-18670866.96467.26
5190124-19012468.19068.49
6189367-18936767.91868.22
30min1195444-19544470.09871.091.4170.5071.501.41
2199276-19927671.47271.88
3194352-19435269.70670.10
4198341-19834171.13771.54
5201071-20107172.11672.53
6200833-20083372.03072.44
45min1208545-20854574.79674.991.0975.3275.521.09
2210424-21042475.47076.00
3204972-20497273.51574.03
4208921-20892174.93175.45
5211392-21139275.81876.35
6210248-21024875.40775.94
60min1212640-21264076.26577.220.9976.9177.870.99
2216424-21642477.62278.28
3212763-21276376.30976.95
4215831-21583177.41078.06
5217872-21787278.14278.80
6216247-21624777.55978.22
90min1221499-22149979.44380.230.9280.2181.010.92
2224334-22433480.45981.24
3221013-22101379.26880.03
4224293-22429380.44581.22
5226354-22635481.18481.97
6224673-22467380.58181.37
120min1227646-22764681.64782.150.9982.5583.060.99
2229690-22969082.38083.30
3225536-22553680.89081.79
4228791-22879182.05882.97
5231771-23177183.12784.05
6230830-23083082.78983.71
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1224719-22471980.59782.761.5281.6483.811.51
2232126-23212683.25484.31
3229071-22907182.15883.19
4231599-23159983.06584.11
5234904-23490484.25085.31
6232115-23211583.25084.31
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100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数100
标示量(mg)160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%
115.759226308922622892232929213929921294892205410.08
215.779205029921114792080880.05
单位质量响应值RSD%判断
585431.17583899.050.19数据可信
供试品溶液-25010701批-缬沙坦-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1255789-2557892.4392.604.042.442.604.03
2264776-2647762.5242.52
3273824-2738242.6112.61
4271750-2717502.5912.59
5281930-2819302.6882.69
6285721-2857212.7242.72
10min1512363-5123634.8855.163.604.895.163.62
2539034-5390345.1395.14
3529910-5299105.0525.06
4542744-5427445.1755.18
5552132-5521325.2645.27
6569620-5696205.4315.44
15min1718855-7188556.8547.283.796.877.293.78
2761443-7614437.2607.27
3747393-7473937.1267.14
4768394-7683947.3267.34
5780117-7801177.4387.45
6803803-8038037.6647.68
20min1896482-8964828.5479.073.588.579.093.59
2949007-9490079.0489.07
3934255-9342558.9078.93
4959334-9593349.1479.17
5970778-9707789.2569.28
6996270-9962709.4999.53
30min11163012-116301211.08912.025.6611.1312.065.66
21239825-123982511.82111.86
31224159-122415911.67211.71
41373580-137358013.09613.14
51264723-126472312.05812.10
61297896-129789612.37512.42
45min11613259-161325915.38115.321.9915.4415.381.97
21575593-157559315.02215.08
31567644-156764414.94615.01
41639517-163951715.63215.69
51603222-160322215.28615.35
61644684-164468415.68115.74
60min11757409-175740916.75617.642.8416.8417.722.84
21842669-184266917.56917.65
31837240-183724017.51717.60
41878822-187882217.91318.00
51875831-187583117.88517.97
61908708-190870818.19818.29
90min12169487-216948720.68521.472.2020.7921.592.21
22233869-223386921.29821.41
32240540-224054021.36221.48
42281523-228152321.75321.87
52277303-227730321.71321.83
62310476-231047622.02922.15
120min12490005-249000523.74124.582.7523.8824.732.75
22551295-255129524.32524.47
32541363-254136324.23024.38
42591643-259164324.71024.86
52595438-259543824.74624.90
62699250-269925025.73625.89
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限12739906-273990626.12326.391.1826.3126.591.19
22734874-273487426.07526.27
32748531-274853126.20526.39
42775288-277528826.46026.66
52797423-279742326.67226.87
62813817-281381726.82827.03
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%
113.922512952514182511412511872511302512340.05
214.042549192560112554650.31
单位质量响应值RSD%判断
18048.4218195.510.58数据可信
供试品溶液-25010702批-氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1159022-15902256.88657.011.9256.8957.011.92
2157874-15787456.47556.47
3164578-16457858.87358.87
4161237-16123757.67857.68
5156931-15693156.13856.14
6156593-15659356.01756.02
10min1180976-18097664.73964.440.7164.8364.530.71
2180643-18064364.62064.71
3180732-18073264.65264.75
4180893-18089364.70964.81
5177677-17767763.55963.65
6179876-17987664.34664.44
15min1193887-19388769.35868.201.1369.5668.401.13
2188930-18893067.58467.79
3191201-19120168.39768.60
4191163-19116368.38368.59
5187643-18764367.12467.32
6191000-19100068.32568.53
20min1199896-19989671.50771.011.1571.8371.331.15
2200483-20048371.71772.03
3198269-19826970.92571.24
4198026-19802670.83871.16
5194355-19435569.52569.84
6200074-20007471.57171.89
30min1210533-21053375.31274.381.1875.7574.811.18
2206245-20624573.77874.21
3208272-20827274.50374.94
4207287-20728774.15174.59
5204464-20446473.14173.57
6210723-21072375.38075.81
45min1216707-21670777.52177.231.0978.0877.781.09
2214204-21420476.62577.18
3217285-21728577.72878.29
4214578-21457876.75977.32
5213112-21311276.23576.78
6219435-21943578.49779.06
60min1222908-22290879.73978.851.1980.4379.531.18
2219395-21939578.48279.17
3221733-22173379.31980.01
4217625-21762577.84978.54
5217479-21747977.79778.47
6223342-22334279.89480.58
90min1229529-22952982.10781.171.0782.9381.991.07
2225162-22516280.54581.36
3227567-22756781.40682.23
4225241-22524180.57481.39
5224158-22415880.18680.99
6229805-22980582.20683.03
120min1231653-23165382.86782.151.0883.8383.101.08
2227563-22756381.40482.35
3230744-23074482.54283.50
4227978-22797881.55382.50
5226976-22697681.19482.13
6232967-23296783.33784.30
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1232854-23285483.29782.651.0684.4083.741.06
2229638-22963882.14683.23
3232965-23296583.33784.43
4229415-22941582.06783.15
5227700-22770081.45382.53
6233698-23369883.59984.70
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100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数100
标示量(mg)160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%
115.759166652916984491666339170517916533591677960.03
215.779309461934539793274290.28
单位质量响应值RSD%判断
582082.29591466.651.14数据可信
供试品溶液-25010702批-缬沙坦-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1742675-7426757.0567.024.307.067.024.32
2722237-7222376.8626.86
3800608-8006087.6067.61
4716502-7165026.8076.81
5735404-7354046.9876.99
6718055-7180556.8226.82
10min11365299-136529912.97112.741.1912.9812.751.18
21350736-135073612.83312.84
31335304-133530412.68612.70
41320795-132079512.54812.56
51329156-132915612.62812.64
61341627-134162712.74612.76
15min11868305-186830517.75016.942.6117.7816.972.61
21746259-174625916.59116.62
31763709-176370916.75616.79
41758892-175889216.71116.74
51756142-175614216.68416.72
61805739-180573917.15617.19
20min12182386-218238620.73420.252.1920.8020.312.20
22167715-216771520.59520.66
32085059-208505919.80919.87
42097565-209756519.92819.99
52084342-208434219.80319.86
62168924-216892420.60620.67
30min12703961-270396125.68925.071.9225.7925.161.92
22608606-260860624.78324.88
32606619-260661924.76524.86
42609428-260942824.79124.88
52600179-260017924.70324.80
62703529-270352925.68525.78
45min13208046-320804630.47830.141.5530.6230.281.55
23149566-314956629.92330.06
33157996-315799630.00330.14
43134522-313452229.78029.91
53131359-313135929.75029.88
63255060-325506030.92531.06
60min13649759-364975934.67533.841.7834.8734.031.77
23532839-353283933.56433.75
33514953-351495333.39433.58
43530531-353053133.54233.73
53508511-350851133.33333.52
63635021-363502134.53534.72
90min14162359-416235939.54538.841.3539.7939.081.35
24062070-406207038.59238.83
34064557-406455738.61638.86
44044547-404454738.42638.67
54040841-404084138.39138.63
64154059-415405939.46639.71
120min14504731-450473142.79842.081.2643.1142.391.26
24397594-439759441.78042.09
34404673-440467341.84742.15
44397860-439786041.78242.09
54374789-437478941.56341.87
64494202-449420242.69843.01
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限14590480-459048043.61243.440.4944.0043.820.50
24580128-458012843.51443.89
34581005-458100543.52243.90
44534572-453457243.08143.46
54555792-455579243.28343.66
64590409-459040943.61244.00
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%
113.922514462515582513532515762515662515000.04
214.042531732530552531140.04
单位质量响应值RSD%判断
18067.5318028.060.16数据可信
供试品溶液-APCE853批-氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1114053-11405340.96639.582.9040.9739.582.90
2109134-10913439.19939.20
3109033-10903339.16339.16
4110484-11048439.68439.68
5105268-10526837.81137.81
6113233-11323340.67240.67
10min1143885-14388551.68250.473.0651.7550.543.06
2139284-13928450.02950.09
3142888-14288851.32351.39
4138919-13891949.89849.96
5133282-13328247.87347.94
6144822-14482252.01852.09
15min1157448-15744856.55354.962.3356.7155.122.33
2152526-15252654.78554.93
3154361-15436155.44455.60
4152696-15269654.84655.00
5146730-14673052.70352.85
6154390-15439055.45555.61
20min1166552-16655259.82358.042.4160.0758.282.41
2160676-16067657.71357.95
3163720-16372058.80659.05
4161077-16107757.85758.10
5154929-15492955.64855.88
6162605-16260558.40558.65
30min1177846-17784663.88062.162.2164.2362.502.21
2172118-17211861.82262.16
3175630-17563063.08463.43
4172742-17274262.04762.38
5166557-16655759.82560.15
6173393-17339362.28062.62
45min1188142-18814267.57866.151.7768.0366.591.77
2183508-18350865.91466.35
3185884-18588466.76767.21
4183068-18306865.75566.20
5178679-17867964.17964.60
6185686-18568666.69667.14
60min1195163-19516370.10068.781.7770.6769.341.78
2190379-19037968.38268.93
3193488-19348869.49870.06
4190998-19099868.60469.15
5185594-18559466.66367.19
6193369-19336969.45570.01
90min1203550-20355073.11271.412.5073.8072.082.49
2200276-20027671.93672.60
3202115-20211572.59773.27
4191788-19178868.88869.55
5193412-19341269.47170.11
6201741-20174172.46373.14
120min1208255-20825574.80273.801.5275.6174.591.53
2204849-20484973.57974.36
3207056-20705674.37275.17
4205668-20566873.87374.65
5199617-19961771.70072.46
6207356-20735674.47975.28
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1210789-21078975.71274.901.5076.6475.811.51
2207693-20769374.60075.51
3210631-21063175.65676.57
4208601-20860174.92775.83
5202732-20273272.81973.69
6210780-21078075.70976.63
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100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数100
标示量(mg)160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%
115.759209322920978592116199211676921156592107930.02
215.779262540925326092579000.08
单位质量响应值RSD%判断
584812.25587057.700.28数据可信
供试品溶液-APCE853批-缬沙坦-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1448624-4486244.2684.052.894.274.052.93
2423931-4239314.0334.03
3418398-4183983.9813.98
4415663-4156633.9543.95
5418627-4186273.9833.98
6430357-4303574.0944.09
10min1889138-8891388.4598.123.688.478.133.69
2840544-8405447.9978.00
3877188-8771888.3458.35
4827804-8278047.8757.88
5811712-8117127.7227.73
6875975-8759758.3348.34
15min11249989-124998911.89211.223.5711.9111.243.56
21176150-117615011.19011.21
31202042-120204211.43611.46
41167089-116708911.10311.12
51143211-114321110.87610.90
61135954-113595410.80710.83
20min11540668-154066814.65713.963.1114.7014.003.11
21461900-146190013.90813.95
31498541-149854114.25714.30
41451845-145184513.81213.85
51419160-141916013.50113.54
61429705-142970513.60213.64
30min12022466-202246619.24118.223.2719.3118.283.27
21912506-191250618.19518.26
31943496-194349618.49018.55
41896416-189641618.04218.10
51864272-186427217.73617.80
61850059-185005917.60117.66
45min12506940-250694023.85023.201.8123.9523.301.82
22446655-244665523.27723.37
32466935-246693523.47023.56
42409600-240960022.92423.02
52418158-241815823.00623.10
62384370-238437022.68422.77
60min12931659-293165927.89127.211.7328.0327.341.74
22901026-290102627.59927.73
32867609-286760927.28227.41
42840453-284045327.02327.15
52806691-280669126.70226.83
62814086-281408626.77226.90
90min13501028-350102833.30832.571.4333.4932.741.44
23437071-343707132.69932.88
33444359-344435932.76932.95
43397990-339799032.32732.50
53360449-336044931.97032.14
63398021-339802132.32832.50
120min13870979-387097936.82736.400.9137.0736.630.92
23829498-382949836.43336.66
33834098-383409836.47636.71
43841285-384128536.54536.77
53767171-376717135.84036.07
63810977-381097736.25636.48
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限14185586-418558639.82039.320.8640.1239.610.87
24130465-413046539.29639.59
34149398-414939839.47639.77
44127280-412728039.26639.55
54076230-407623038.78039.07
64129319-412931939.28539.57
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