厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100309-201404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10000
标示量(mg)12.5供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.859479295199950819512295391951170.23
212.919487094906948880.03
单位质量响应值RSD%判断
7402.107349.960.50数据可信
长期12月-供试品溶液-2023061621批-氢氯噻嗪-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min154094-5409458.49550.969.5358.4950.969.53
241653-4165345.04245.04
347818-4781851.70851.71
449218-4921853.22253.22
547026-4702650.85250.85
642947-4294746.44146.44
10min183994-8399490.82790.011.0091.1290.261.02
282023-8202388.69688.92
383057-8305789.81490.07
483553-8355390.35090.62
584187-8418791.03691.29
682620-8262089.34189.57
15min187146-8714694.23694.651.0994.9895.361.07
286921-8692193.99294.66
387955-8795595.11095.82
486343-8634393.36794.09
587761-8776194.90195.61
689062-8906296.30896.99
20min188623-8862395.83396.550.9897.0597.720.96
289063-8906396.30997.45
389852-8985297.16298.34
488015-8801595.17596.36
589821-8982197.12898.31
690323-9032397.67198.83
30min190410-9041097.76597.911.1899.4699.571.15
290551-9055197.91899.54
390271-9027197.61599.28
488978-8897896.21797.88
590779-9077998.16499.83
692282-9228299.789101.44
45min191128-9112898.54299.000.94100.73101.150.93
291522-9152298.968101.08
391787-9178799.254101.41
490333-9033397.68299.82
591597-9159799.049101.21
692957-92957100.519102.67
60min188197-8819795.37295.481.4998.0598.131.46
287607-8760794.73497.34
388307-8830795.49198.14
486540-8654093.58096.21
588624-8862495.83498.49
690513-9051397.877100.53
极限188284-8828495.46696.951.3998.62100.071.34
290627-9062798.000101.08
389133-8913396.38499.52
488263-8826395.44498.54
590805-9080598.192101.33
690816-9081698.204101.34
厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100607-201804对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)150供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.322661492666702668792671942671662668120.17
215.352690072686352688210.10
单位质量响应值RSD%判断
17415.9317512.770.40数据可信
长期12月-供试品溶液-2023061621批-厄贝沙坦-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1106228-10622840.55135.908.4340.5535.908.43
286144-8614432.88432.88
395428-9542836.42836.43
497865-9786537.35837.36
593923-9392335.85435.85
684733-8473332.34532.35
10min1207291-20729179.13075.573.3579.3375.753.35
2192471-19247173.47373.64
3203413-20341377.64977.83
4197668-19766875.45675.64
5197519-19751975.40075.58
6189489-18948972.33472.50
15min1233335-23333589.07289.130.6989.6789.690.68
2230942-23094288.15888.69
3234005-23400589.32789.90
4233126-23312688.99289.56
5233638-23363889.18789.74
6235920-23592090.05890.58
20min1245863-24586393.85493.402.3094.9094.402.28
2243514-24351492.95793.93
3249627-24962795.29196.31
4247254-24725494.38595.39
5234008-23400889.32990.33
6247754-24775494.57695.55
30min1255516-25551697.53997.100.9399.0598.570.92
2251698-25169896.08197.52
3252192-25219296.27097.76
4253955-25395596.94398.42
5254659-25465997.21298.66
6258138-25813898.54099.99
45min1258020-25802098.49598.350.76100.50100.310.75
2255200-25520097.41899.34
3258258-25825898.586100.56
4256544-25654497.93199.90
5256926-25692698.077100.01
6260890-26089099.590101.53
60min1249157-24915795.11194.801.4497.6097.251.42
2243816-24381693.07395.48
3247854-24785494.61497.08
4245976-24597693.89796.35
5248844-24884494.99297.42
6254392-25439297.11099.55
极限1249318-24931895.17396.221.4298.1499.141.35
2254268-25426897.06299.93
3249901-24990195.39598.34
4247532-24753294.49197.42
5255347-25534797.474100.37
6255957-25595797.707100.63
厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100309-201404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10000
标示量(mg)12.5供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.859479094962945689480794953948160.17
212.919529794809950530.37
单位质量响应值RSD%判断
7378.687362.740.16数据可信
长期12月-供试品溶液-2023061621批-氢氯噻嗪-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min146107-4610749.89346.6511.4449.8946.6411.44
242164-4216445.62745.63
335012-3501237.88737.89
449878-4987853.97453.97
542686-4268646.19146.19
642788-4278846.30246.30
10min183367-8336790.21389.712.3790.4689.942.39
282745-8274589.54089.77
379264-7926485.77385.96
485048-8504892.03292.30
583936-8393690.82991.06
683039-8303989.85890.09
15min188187-8818795.42996.931.4196.1397.621.42
289614-8961496.97397.65
388898-8889896.19996.82
491845-9184599.388100.12
589876-8987697.25797.94
689036-8903696.34897.03
20min189058-8905896.37298.681.4397.5599.851.43
292251-9225199.827100.99
391134-9113498.61899.72
492828-92828100.451101.68
591057-9105798.53599.71
690844-9084498.30499.47
30min191050-9105098.52799.030.93100.19100.690.95
290911-9091198.377100.04
390529-9052997.96399.56
492845-92845100.470102.20
591728-9172899.261100.92
692007-9200799.563101.22
45min194326-94326102.072101.191.37104.22103.341.37
294468-94468102.226104.38
391809-9180999.349101.43
493734-93734101.432103.66
594707-94707102.485104.64
692017-9201799.574101.73
60min191076-9107698.555100.041.04101.22102.701.03
292806-92806100.427103.09
391959-9195999.511102.09
493401-93401101.071103.81
591935-9193599.485102.16
693518-93518101.198103.85
极限191702-9170299.233100.090.96102.39103.250.96
293727-93727101.424104.59
391966-9196699.518102.59
493138-93138100.787104.03
592897-92897100.526103.70
691546-9154699.064102.22
厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100607-201804对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)150供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.322684362684012683262684372685182684240.03
215.352682532678642680580.11
单位质量响应值RSD%判断
17521.1517463.060.24数据可信
长期12月-供试品溶液-2023061621批-厄贝沙坦-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min187668-8766833.41232.7514.8433.4132.7414.84
278881-7888130.06430.06
366017-6601725.16125.16
4104367-10436739.77739.78
589185-8918533.99133.99
689405-8940534.07534.07
10min1205619-20561978.36777.333.1678.5377.493.19
2203700-20370077.63577.79
3190851-19085172.73872.86
4209838-20983879.97580.17
5204859-20485978.07778.25
6202464-20246477.16477.33
15min1235902-23590289.90891.271.8890.4791.821.90
2239346-23934691.22191.76
3234036-23403689.19789.69
4246848-24684894.08094.68
5241449-24144992.02292.58
6239305-23930591.20591.76
20min1246308-24630893.87495.971.4694.8896.981.47
2254243-25424396.89897.89
3249919-24991995.25096.19
4256551-25655197.77898.85
5253450-25345096.59697.62
6250447-25044795.45296.46
30min1255967-25596797.55697.971.1399.0399.461.16
2254359-25435996.94398.42
3253555-25355596.63698.05
4260895-26089599.434100.99
5259254-25925498.808100.31
6258347-25834798.46399.95
45min1266646-266646101.626100.411.68103.59102.391.68
2265833-265833101.316103.28
3257284-25728498.05799.95
4263667-263667100.490102.55
5268362-268362102.280104.28
6259001-25900198.712100.69
60min1256170-25617097.63399.080.85100.11101.560.85
2260130-26013099.142101.61
3259557-25955798.924101.31
4261489-26148999.660102.22
5259835-25983599.030101.54
6262699-262699100.121102.60
极限1257514-25751498.14599.151.00101.11102.131.00
2262894-262894100.196103.16
3259492-25949298.899101.78
4262941-262941100.213103.27
5261119-26111999.519102.52
6256993-25699397.947100.92
厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100309-201404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10000
标示量(mg)12.5供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.859532295089953889536895533953400.17
212.919524995574954120.25
单位质量响应值RSD%判断
7419.467390.550.28数据可信
长期12月-供试品溶液-2023061621批-氢氯噻嗪-pH4.5(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min133112-3311235.66535.5618.4735.6735.5618.47
229542-2954231.82031.82
339189-3918942.21142.21
433878-3387836.49036.49
523169-2316924.95624.96
639176-3917642.19742.20
10min171286-7128676.78379.863.2376.9680.043.24
272820-7282078.43578.59
373268-7326878.91879.13
476520-7652082.42182.60
573422-7342279.08479.21
677565-7756583.54683.76
15min178342-7834284.38386.541.8184.9587.121.82
279870-7987086.02986.58
379774-7977485.92686.53
481306-8130687.57688.17
580206-8020686.39186.91
682584-8258488.95289.58
20min179231-7923185.34188.672.3086.3289.682.30
282122-8212288.45589.44
382241-8224188.58389.62
482578-8257888.94689.98
582612-8261288.98389.93
685158-8515891.72592.80
30min184630-8463091.15692.150.9592.5793.600.98
285296-8529691.87393.30
385094-8509491.65693.13
485775-8577592.38993.87
585504-8550492.09893.49
686997-8699793.70695.24
45min183382-8338289.81293.592.3791.6895.502.36
287426-8742694.16896.05
388197-8819794.99896.93
487283-8728394.01495.95
585829-8582992.44894.31
689227-8922796.10898.11
60min187635-8763594.39395.081.5096.7197.461.50
286497-8649793.16795.52
390270-9027097.23199.64
487822-8782294.59497.00
588205-8820595.00797.33
689232-8923296.11398.59
极限191765-9176598.84197.371.97101.63100.231.92
288122-8812294.91797.74
388290-8829095.09898.00
492186-9218699.295102.18
590612-9061297.599100.39
691422-9142298.472101.43
厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100607-201804对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)150供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.322696622694052697902690952689012693710.14
215.352705642707162706400.04
单位质量响应值RSD%判断
17582.9617631.270.20数据可信
长期12月-供试品溶液-2023061621批-厄贝沙坦-pH4.5(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min154118-5411820.49121.3921.2020.4921.3921.19
251895-5189519.64919.65
369920-6992026.47426.47
456368-5636821.34321.34
537675-3767514.26514.27
668952-6895226.10826.11
10min1153323-15332358.05460.844.7258.1660.954.74
2158951-15895160.18460.28
3161705-16170561.22761.36
4168857-16885763.93564.04
5151651-15165157.42057.49
6169648-16964864.23564.37
15min1189022-18902271.57074.263.0571.9674.673.07
2195653-19565374.08174.48
3197078-19707874.62175.06
4202331-20233176.61077.04
5189724-18972471.83672.19
6202992-20299276.86077.31
20min1203743-20374377.14481.023.0677.8981.803.08
2213481-21348180.83181.60
3215613-21561381.63982.45
4218925-21892582.89383.70
5210019-21001979.52180.24
6222118-22211884.10284.94
30min1231213-23121387.54588.811.4188.6890.001.45
2233708-23370888.49089.66
3233835-23383588.53889.76
4238424-23842490.27691.50
5231415-23141587.62288.74
6238732-23873290.39291.65
45min1234793-23479388.90192.992.5790.4794.622.58
2245516-24551692.96194.58
3250168-25016894.72296.38
4249972-24997294.64896.32
5242035-24203591.64393.20
6251007-25100795.04096.75
60min1247669-24766993.77694.921.7695.7997.021.76
2244341-24434192.51694.60
3257236-25723697.39999.53
4251990-25199095.41297.56
5250697-25069794.92396.93
6252246-25224695.50997.69
极限1256844-25684497.25096.051.9199.7498.621.87
2247663-24766393.77496.32
3247691-24769193.78596.41
4258733-25873397.965100.59
5254329-25432996.29898.78
6256708-25670897.19999.86
厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100309-201404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10000
标示量(mg)12.5供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.859577995766952389548295431955390.25
212.919475794716947360.04
单位质量响应值RSD%判断
7434.947338.190.93数据可信
长期12月-供试品溶液-2023061621批-氢氯噻嗪-pH4.5(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min124280-2428026.21936.1321.5026.2236.1321.49
238135-3813541.18041.18
333575-3357536.25636.26
441879-4187945.22345.22
537494-3749440.48840.49
625380-2538027.40627.41
10min170484-7048476.11281.943.9676.2482.123.97
274553-7455380.50680.71
378082-7808284.31684.50
478477-7847784.74384.97
576292-7629282.38482.59
677407-7740783.58883.72
15min176992-7699283.13988.593.1983.6589.183.21
282227-8222788.79289.40
382002-8200288.54989.15
483902-8390290.60191.25
584055-8405590.76691.38
683076-8307689.70990.26
20min180021-8002186.41090.542.9087.3491.572.92
282556-8255689.14890.20
384140-8414090.85891.90
484666-8466691.42692.53
587346-8734694.32095.39
684316-8431691.04892.05
30min182855-8285589.47193.112.2490.8394.592.26
284929-8492991.71093.21
387258-8725894.22595.72
487232-8723294.19795.76
587428-8742894.40995.95
687630-8763094.62796.09
45min179722-7972286.08793.053.8287.8995.003.82
286306-8630693.19795.15
388915-8891596.01497.99
487448-8744894.43096.46
586705-8670593.62895.64
687915-8791594.93596.87
60min188960-8896096.06396.561.4398.3098.981.44
288293-8829395.34397.77
391366-9136698.661101.11
489395-8939596.53399.04
590451-9045197.673100.15
688063-8806395.09497.50
极限189545-8954596.69597.360.7499.41100.260.74
290504-9050497.730100.63
390939-9093998.200101.14
489838-8983897.011100.00
589366-8936696.50199.47
690774-9077498.022100.90
厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100607-201804对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)150供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.322690752696902691262695252696622694160.11
215.352686112681862683980.12
单位质量响应值RSD%判断
17585.9017485.210.41数据可信
长期12月-供试品溶液-2023061621批-厄贝沙坦-pH4.5(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min140453-4045315.38021.6225.1015.3821.6225.10
266837-6683725.41025.41
357446-5744621.84021.84
473251-7325127.84927.85
564352-6435224.46624.47
638846-3884614.76914.77
10min1151845-15184557.72962.134.3457.8162.244.37
2164355-16435562.48562.61
3162738-16273861.87061.98
4173805-17380566.07866.22
5165894-16589463.07063.19
6161924-16192461.56161.63
15min1186858-18685871.04075.633.7071.4176.053.72
2200640-20064076.28076.72
3195008-19500874.13974.56
4207287-20728778.80779.28
5204893-20489377.89778.33
6198847-19884775.59875.98
20min1207990-20799079.07482.473.1179.8083.273.13
2213510-21351081.17381.99
3214684-21468481.61982.41
4220649-22064983.88784.75
5227731-22773186.57987.41
6216989-21698982.49683.26
30min1228524-22852486.88189.912.0888.0091.122.10
2233073-23307388.61089.84
3236343-23634389.85491.05
4240589-24058991.46892.75
5240805-24080591.55092.81
6239657-23965791.11492.29
45min1226159-22615985.98292.343.4787.5394.003.46
2243154-24315492.44394.11
3247658-24765894.15595.80
4246638-24663893.76895.51
5245199-24519993.22194.94
6248472-24847294.46596.09
60min1250139-25013995.09996.071.1897.0898.191.20
2250171-25017195.11197.24
3256724-25672497.60299.72
4253813-25381396.49598.70
5255240-25524097.03899.22
6250074-25007495.07497.17
极限1251733-25173395.70596.060.5998.1698.660.58
2253050-25305096.20598.81
3254146-25414696.62299.23
4252956-25295696.17098.86
5250204-25020495.12397.79
6253919-25391996.53699.11
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