坎地沙坦酯氢氯噻嗪片项目信息
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100309-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数1000
标示量(mg)12.5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%
112.174694084695154697154696904698764696410.04
212.154688424687034687720.03
单位质量响应值RSD%判断
38590.0638582.060.02数据可信
供试品溶液-24042901批-氢氯噻嗪-pH6.8(内含0.35%吐温20)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1313461-31346158.31559.198.3058.3259.208.30
2357920-35792066.58666.59
3337461-33746162.78062.78
4312712-31271258.17658.18
5305701-30570156.87156.87
6281826-28182652.43052.43
10min1399791-39979174.37677.132.7674.4777.222.76
2425593-42559379.17679.29
3424644-42464478.99979.10
4423096-42309678.71178.81
5410901-41090176.44276.54
6403416-40341675.05075.14
15min1428530-42853079.72281.841.4079.9482.061.40
2440977-44097782.03882.28
3443694-44369482.54382.78
4446426-44642683.05183.28
5439013-43901381.67281.89
6440691-44069181.98482.20
20min1444876-44487682.76383.760.8083.1284.130.79
2447657-44765783.28083.66
3451168-45116883.93484.31
4454739-45473984.59884.96
5450059-45005983.72784.09
6453006-45300684.27584.62
30min1462248-46224885.99586.230.6686.4986.740.65
2458398-45839885.27985.80
3463535-46353586.23486.75
4466618-46661886.80887.32
5463976-46397686.31686.81
6466351-46635186.75887.25
45min1482356-48235689.73688.851.1890.3789.491.17
2467929-46792987.05287.71
3474132-47413288.20688.86
4482477-48247789.75890.41
5479559-47955989.21589.86
6478999-47899989.11189.75
60min1494288-49428891.95590.551.5092.7491.341.48
2474110-47411088.20289.01
3484421-48442190.12090.92
4492898-49289891.69792.50
5489010-48901090.97491.76
6485627-48562790.34491.13
极限1534848-53484899.50198.881.06100.4499.831.06
2524295-52429597.53898.49
3531448-53144898.86999.82
4539307-539307100.331101.29
5533309-53330999.215100.16
6525903-52590397.83798.77
坎地沙坦酯氢氯噻嗪片项目信息
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100685-201903对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8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%
116.081515491513821514961516201515521515200.06
216.021516061514761515410.07
单位质量响应值RSD%判断
9422.899459.490.28数据可信
供试品溶液-24042901批-坎地沙坦酯-pH6.8(内含0.35%吐温20)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min172169-7216942.91241.688.5342.9141.688.53
278858-7885846.88946.89
373310-7331043.59043.59
466974-6697439.82339.82
567671-6767140.23740.24
661641-6164136.65236.65
10min1109185-10918564.92266.443.0464.9966.513.05
2116112-11611269.04169.12
3114105-11410567.84767.92
4112078-11207866.64266.71
5112325-11232566.78966.86
6106642-10664263.41063.47
15min1127233-12723375.65377.631.6075.8377.811.60
2131798-13179878.36878.56
3131880-13188078.41678.60
4132392-13239278.72178.90
5131298-13129878.07078.25
6128727-12872776.54276.71
20min1138244-13824482.20083.391.1982.5183.701.18
2139797-13979783.12483.45
3140896-14089683.77784.09
4142743-14274384.87685.18
5141036-14103683.86184.17
6138749-13874982.50182.80
30min1148056-14805688.03588.791.0988.4889.241.09
2147824-14782487.89788.36
3149849-14984989.10189.56
4151908-15190890.32590.78
5150258-15025889.34489.79
6148075-14807588.04688.48
45min1154214-15421491.69691.601.1792.2992.201.16
2151748-15174890.23090.84
3153630-15363091.34991.95
4156996-15699693.35193.95
5154821-15482192.05792.65
6152903-15290390.91791.50
60min1155503-15550392.46392.431.2493.2193.181.23
2152873-15287390.89991.66
3156005-15600592.76193.52
4158304-15830494.12894.88
5156201-15620192.87893.63
6153814-15381491.45892.19
极限1162053-16205396.35795.631.0497.2596.541.03
2158490-15849094.23995.15
3160628-16062895.51096.42
4162571-16257196.66597.58
5161979-16197996.31397.22
6159282-15928294.71095.59
坎地沙坦酯氢氯噻嗪片项目信息
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100309-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数1000
标示量(mg)12.5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%
112.174661064660324661764663744661534661680.03
212.154686234681454683840.08
单位质量响应值RSD%判断
38304.6838550.120.46数据可信
供试品溶液-24043001批-氢氯噻嗪-pH6.8(内含0.35%吐温20)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1269192-26919250.28760.0311.9350.2960.0411.93
2304634-30463456.90756.91
3314710-31471058.79058.79
4386420-38642072.18672.19
5327931-32793161.26061.26
6325353-32535360.77860.78
10min1411584-41158476.88679.783.0076.9779.883.01
2435489-43548981.35281.45
3429764-42976480.28380.38
4445373-44537383.19883.32
5426116-42611679.60179.70
6414207-41420777.37677.48
15min1437090-43709081.65183.191.9081.8683.421.91
2452057-45205784.44784.68
3448961-44896183.86984.10
4456362-45636285.25185.51
5441972-44197282.56382.80
6435513-43551381.35681.59
20min1449736-44973684.01384.541.4184.3684.911.42
2456558-45655885.28885.66
3458197-45819785.59485.97
4459583-45958385.85386.25
5445159-44515983.15883.53
6445998-44599883.31583.68
30min1456815-45681585.33686.321.3785.8286.831.38
2463285-46328586.54487.06
3469101-46910187.63188.15
4468878-46887887.58988.13
5453505-45350584.71785.23
6460774-46077486.07586.58
45min1472061-47206188.18488.601.5188.8189.251.51
2472953-47295388.35189.01
3482729-48272990.17790.84
4478628-47862889.41190.10
5462082-46208286.32086.97
6477192-47719289.14289.79
60min1477096-47709689.12489.891.9989.9090.691.98
2476334-47633488.98289.79
3494798-49479892.43193.24
4483208-48320890.26691.11
5467800-46780087.38888.18
6487903-48790391.14391.94
极限1520694-52069497.26997.551.3398.1998.501.33
2525936-52593698.24899.20
3527548-52754898.54999.51
4528633-52863398.75299.74
5520343-52034397.20398.14
6510002-51000295.27196.22
坎地沙坦酯氢氯噻嗪片项目信息
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100685-201903对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8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%
116.081507181508261518701511751510841511350.30
216.021516141517591516860.07
单位质量响应值RSD%判断
9398.949468.540.53数据可信
供试品溶液-24043001批-坎地沙坦酯-pH6.8(内含0.35%吐温20)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min162070-6207036.93741.9912.4736.9441.9912.47
267842-6784240.37140.37
368252-6825240.61540.62
487739-8773952.21252.21
569062-6906241.09741.10
668376-6837640.68940.69
10min1111571-11157166.39468.743.9166.4668.813.91
2115864-11586468.94869.02
3116719-11671969.45769.52
4123536-12353673.51473.60
5114190-11419067.95268.02
6111228-11122866.19066.26
15min1133668-13366879.54380.431.9779.7280.621.98
2135744-13574480.77880.96
3137117-13711781.59681.78
4138782-13878282.58682.80
5134393-13439379.97580.16
6131246-13124678.10278.28
20min1144344-14434485.89686.091.3086.2086.411.31
2145292-14529286.46086.78
3147149-14714987.56587.88
4146075-14607586.92687.27
5143011-14301185.10385.42
6142165-14216584.59984.91
30min1151708-15170890.27890.581.1590.7391.041.15
2153314-15331491.23491.69
3154967-15496792.21892.68
4152338-15233890.65391.15
5150216-15021689.39089.85
6150735-15073589.69990.15
45min1156296-15629693.00992.571.4693.6193.181.45
2156947-15694793.39694.01
3158701-15870194.44095.06
4154556-15455691.97392.62
5152187-15218790.56391.17
6154623-15462392.01392.61
60min1156567-15656793.17093.061.6293.9293.831.62
2156748-15674893.27894.05
3160851-16085195.71996.50
4155336-15533692.43793.23
5153179-15317991.15491.91
6155623-15562392.60893.36
极限1160279-16027995.37995.311.3596.2996.241.36
2160843-16084395.71496.64
3162393-16239396.63797.57
4162242-16224296.54797.50
5158235-15823594.16295.07
6157023-15702393.44194.35
坎地沙坦酯氢氯噻嗪片项目信息
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100309-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数1000
标示量(mg)12.5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%
112.174649234665734684714704304711204683030.56
212.154651974645964648960.10
单位质量响应值RSD%判断
38480.1238263.050.41数据可信
供试品溶液-24043002批-氢氯噻嗪
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1219477-21947741.05941.178.2041.0641.178.20
2220060-22006041.16841.17
3195837-19583736.63736.64
4208333-20833338.97438.97
5227718-22771842.60142.60
6249119-24911946.60546.60
10min1340547-34054763.70966.966.4963.7867.036.49
2366494-36649468.56368.63
3325754-32575460.94161.00
4373973-37397369.96270.03
5351495-35149565.75765.83
6389270-38927072.82472.90
15min1398755-39875574.59878.115.1974.7778.295.19
2425113-42511379.52979.71
3390874-39087473.12473.29
4434795-43479581.34081.52
5408831-40883176.48376.66
6446693-44669383.56683.77
20min1421860-42186078.92082.723.8179.2283.033.82
2449463-44946384.08484.40
3424785-42478579.46879.75
4455777-45577785.26685.58
5437837-43783781.90982.22
6463230-46323086.66087.00
30min1449988-44998884.18387.802.6184.6188.252.62
2474724-47472488.81089.27
3460208-46020886.09586.51
4479470-47947089.69890.16
5469760-46976087.88288.33
6481801-48180190.13490.62
45min1480600-48060089.90992.541.6590.4893.141.66
2501629-50162993.84394.45
3489354-48935491.54792.11
4500413-50041393.61694.22
5496789-49678992.93893.53
6499205-49920593.39094.02
60min1500016-50001693.54295.491.2294.2696.241.23
2518322-51832296.96697.73
3507618-50761894.96495.68
4513640-51364096.09096.86
5511864-51186495.75896.50
6511190-51119095.63296.42
极限1525653-52565398.33899.551.0799.21100.461.06
2539531-539531100.934101.86
3532383-53238399.597100.47
4535254-535254100.134101.06
5534793-534793100.048100.95
6525300-52530098.27299.22
坎地沙坦酯氢氯噻嗪片项目信息
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100685-201903对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8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%
116.081512651514311522821528331530041521630.53
216.021508281509691508980.07
单位质量响应值RSD%判断
9462.879419.350.33数据可信
供试品溶液-24043002批-坎地沙坦酯
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min151202-5120230.44529.536.1730.4529.536.18
248745-4874528.98428.98
345538-4553827.07727.08
447189-4718928.05928.06
551488-5148830.61530.62
653809-5380931.99532.00
10min194360-9436056.10756.835.1856.1656.885.18
296152-9615257.17357.22
387682-8768252.13752.18
495198-9519856.60656.65
596964-9696457.65657.71
6103053-10305361.27661.33
15min1120776-12077671.81573.754.3471.9673.894.33
2124675-12467574.13374.28
3116707-11670769.39569.53
4124650-12465074.11874.26
5124412-12441273.97774.12
6132922-13292279.03779.19
20min1135188-13518880.38482.673.4280.6582.933.42
2139706-13970683.07183.34
3132966-13296679.06379.31
4141233-14123383.97984.24
5138574-13857482.39782.67
6146485-14648587.10187.39
30min1148874-14887488.52291.242.2188.9291.642.22
2154534-15453491.88792.29
3150037-15003789.21489.59
4155862-15586292.67793.08
5153673-15367391.37691.78
6157649-15764993.74094.17
45min1158621-15862194.31896.121.1194.8696.671.11
2163175-16317597.02597.58
3160518-16051895.44695.97
4163209-16320997.04697.60
5162485-16248596.61597.18
6161888-16188896.26096.85
60min1162268-16226896.48697.410.9497.1998.130.94
2165744-16574498.55399.27
3163315-16331597.10997.80
4165115-16511598.17998.90
5164514-16451497.82298.54
6161997-16199796.32597.07
极限1164889-16488998.04598.120.9498.9199.000.93
2167256-16725699.452100.34
3164278-16427897.68198.53
4166301-16630198.88499.77
5164537-16453797.83598.72
6162878-16287896.84997.76
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