苯磺酸左氨氯地平缬沙坦片项目信息
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100374-202105对照品来源中检院对照品使用方法分装
对照品含量(%)97.3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%
113.962399112399942402122401452399922400510.06
214.052422502418252420380.13
单位质量响应值RSD%判断
17195.6317226.900.13数据可信
供试品溶液-8170102批-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%
5min1202717-20271774.36571.873.2274.3671.863.22
2203208-20320874.54574.55
3195284-19528471.63871.64
4191333-19133370.18970.19
5187094-18709468.63468.63
6195793-19579371.82571.82
10min1250577-25057791.92289.102.6092.0589.222.60
2246313-24631390.35890.48
3237990-23799087.30587.42
4235987-23598786.57086.69
5237941-23794187.28787.40
6248461-24846191.14691.27
15min1267840-26784098.25594.533.1598.5394.803.14
2261011-26101195.75096.02
3249104-24910491.38291.65
4251753-25175392.35392.61
5250979-25097992.06992.33
6265396-26539697.35897.63
20min1272830-272830100.08596.732.91100.5397.162.91
2263550-26355096.68197.12
3253862-25386293.12793.54
4261240-26124095.83496.25
5258157-25815794.70395.12
6272492-27249299.961100.40
30min1277050-277050101.63398.412.94102.2499.002.93
2268189-26818998.38398.98
3257267-25726794.37694.95
4268671-26867198.56099.13
5261832-26183296.05196.62
6276622-276622101.476102.08
45min1278759-278759102.26098.703.14103.0499.453.13
2268820-26882098.61499.37
3256888-25688894.23794.97
4269265-26926598.77899.52
5262852-26285296.42597.16
6277697-277697101.871102.64
60min1277359-277359101.74798.283.03102.6999.203.03
2267402-26740298.09499.02
3255689-25568993.79794.68
4269680-26968098.93099.83
5262120-26212096.15697.05
6275220-275220100.962101.90
90min1275029-275029100.89297.822.96102.0198.902.95
2266109-26610997.62098.71
3254989-25498993.54094.58
4268905-26890598.64599.71
5260501-26050195.56396.61
6274412-274412100.666101.77
120min1274830-274830100.81997.313.04102.1098.553.04
2263559-26355996.68497.93
3253628-25362893.04194.24
4267919-26791998.28499.52
5259217-25921795.09196.30
6272454-27245499.947101.22
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1273336-273336100.27196.993.01101.7298.393.01
2262425-26242596.26897.68
3253951-25395193.16094.51
4266039-26603997.59498.99
5257579-25757994.49195.86
6272976-272976100.139101.58
苯磺酸左氨氯地平缬沙坦片项目信息
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100374-202105对照品来源中检院对照品使用方法分装
对照品含量(%)97.3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%
113.962410552411512412552414862417122413320.12
214.052408212409022408620.03
单位质量响应值RSD%判断
17287.3917143.200.60数据可信
供试品溶液-8170102批-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%
5min1188978-18897869.31066.288.8069.3166.288.80
2196595-19659572.10372.10
3189521-18952169.50969.51
4153232-15323256.20056.20
5171149-17114962.77162.77
6184862-18486267.80067.80
10min1239090-23909087.68983.677.0787.8083.787.07
2241126-24112688.43688.56
3231276-23127684.82384.94
4198996-19899672.98473.08
5220543-22054380.88780.99
6237800-23780087.21687.33
15min1253708-25370893.05089.526.6093.3189.776.61
2256850-25685094.20394.47
3246430-24643090.38190.64
4215443-21544379.01679.23
5235855-23585586.50386.74
6256250-25625093.98394.24
20min1259189-25918995.06192.325.6495.4892.725.65
2264474-26447496.99997.42
3254252-25425293.25093.66
4226681-22668183.13883.48
5244177-24417789.55589.94
6261598-26159895.94496.36
30min1263244-26324496.54895.024.7297.1295.574.73
2271885-27188599.717100.30
3260784-26078495.64696.21
4239714-23971487.91888.40
5249811-24981191.62192.15
6269080-26908098.68899.26
45min1263759-26375996.73796.353.3797.4797.063.39
2273575-273575100.337101.09
3262578-26257896.30397.03
4250148-25014891.74592.38
5255542-25554293.72394.41
6270659-27065999.267100.01
60min1263331-26333196.58096.752.7597.4897.622.77
2273936-273936100.469101.39
3261792-26179296.01596.90
4257150-25715094.31395.10
5255865-25586593.84194.68
6270724-27072499.291100.20
90min1262539-26253996.28996.752.3597.3597.782.36
2271847-27184799.703100.79
3261418-26141895.87896.92
4262984-26298496.45297.39
5254506-25450693.34394.34
6269461-26946198.82899.90
120min1261003-26100395.72696.362.4896.9497.552.48
2270908-27090899.359100.61
3259389-25938995.13496.34
4264577-26457797.03798.14
5252678-25267892.67393.83
6267807-26780798.22199.46
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1260608-26060895.58196.342.4796.9697.692.47
2271270-27127099.491100.91
3259074-25907495.01896.38
4263850-26385096.77098.03
5253255-25325592.88494.19
6267998-26799898.29199.69
苯磺酸左氨氯地平缬沙坦片项目信息
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100374-202105对照品来源中检院对照品使用方法分装
对照品含量(%)97.3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%
113.962416442418482415152414132414682415780.08
214.052384512384212384360.01
单位质量响应值RSD%判断
17305.0116970.531.39数据可信
供试品溶液-8170102批-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%
5min1155782-15578257.39854.494.7657.4054.494.76
2150296-15029655.37655.38
3139371-13937151.35151.35
4140225-14022551.66651.67
5146855-14685554.10954.11
6154760-15476057.02157.02
10min1215091-21509179.25076.623.9179.3576.713.91
2205974-20597475.89175.98
3198063-19806372.97673.06
4199133-19913373.37073.46
5212861-21286178.42878.52
6216597-21659779.80579.90
15min1241883-24188389.12285.263.5889.3585.483.58
2226567-22656783.47883.70
3222655-22265582.03782.24
4224003-22400382.53482.74
5233320-23332085.96786.19
6239948-23994888.40988.64
20min1255628-25562894.18689.693.4794.5690.053.47
2239467-23946788.23188.59
3232766-23276685.76286.11
4237692-23769287.57787.92
5245032-24503290.28290.65
6249897-24989792.07492.45
30min1264582-26458297.48593.642.7198.0294.162.71
2248535-24853591.57392.08
3247666-24766691.25291.74
4249598-24959891.96492.46
5254736-25473693.85794.37
6259844-25984495.73996.27
45min1268298-26829898.85494.973.1599.5595.643.15
2257250-25725094.78495.44
3249595-24959591.96392.60
4247972-24797291.36592.01
5258287-25828795.16695.84
6265142-26514297.69198.38
60min1271646-271646100.08896.172.82100.9597.002.82
2257477-25747794.86795.68
3250954-25095492.46493.26
4256891-25689194.65195.45
5263924-26392497.24398.07
6265232-26523297.72598.58
90min1270816-27081699.78296.452.19100.8197.442.20
2258772-25877295.34496.32
3256969-25696994.68095.63
4256116-25611694.36695.32
5261972-26197296.52397.52
6266026-26602698.01799.03
120min1273462-273462100.75796.272.87101.9597.412.87
2259514-25951495.61896.75
3253330-25333093.33994.44
4254084-25408493.61794.73
5262667-26266796.77997.93
6264638-26463897.50698.68
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1272717-272717100.48296.412.69101.8497.722.69
2258998-25899895.42896.72
3255456-25545694.12395.38
4254791-25479193.87895.15
5260802-26080296.09297.41
6267238-26723898.46499.80
苯磺酸左氨氯地平缬沙坦片项目信息
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100374-202105对照品来源中检院对照品使用方法分装
对照品含量(%)97.3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%
113.962398832400642399032400592398722399560.05
214.052389722387212388460.08
单位质量响应值RSD%判断
17188.8316999.720.79数据可信
供试品溶液-8170102批-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%
5min1152282-15228256.24756.295.7956.2556.295.79
2151563-15156355.98255.98
3165221-16522161.02761.03
4158942-15894258.70758.71
5140986-14098652.07552.08
6145344-14534453.68553.68
10min1208102-20810276.86577.323.1176.9677.423.11
2208612-20861277.05477.15
3220027-22002781.27081.37
4212697-21269778.56278.66
5200942-20094274.22174.31
6205691-20569175.97576.06
15min1236445-23644587.33486.023.1087.5686.243.10
2234470-23447086.60586.83
3240505-24050588.83489.07
4236546-23654687.37187.60
5220341-22034181.38681.60
6228969-22896984.57384.79
20min1246602-24660291.08690.232.1191.4590.602.11
2243944-24394490.10490.47
3251990-25199093.07693.46
4244516-24451690.31590.69
5236341-23634187.29687.64
6242311-24231189.50189.86
30min1256511-25651194.74694.261.5495.2694.781.55
2256399-25639994.70495.22
3261143-26114396.45797.00
4254458-25445893.98794.51
5249363-24936392.10592.60
6253297-25329793.55994.06
45min1259409-25940995.81696.111.0796.4996.781.07
2259630-25963095.89896.57
3264460-26446097.68298.38
4260106-26010696.07496.76
5256050-25605094.57595.22
6261514-26151496.59497.26
60min1262333-26233396.89696.671.1097.7397.511.10
2262441-26244196.93697.77
3264931-26493197.85698.72
4260092-26009296.06896.91
5256918-25691894.89695.70
6263663-26366397.38798.21
90min1262797-26279797.06796.731.2098.0797.721.20
2263764-26376497.42598.42
3262486-26248696.95397.98
4259422-25942295.82196.82
5257062-25706294.94995.91
6265734-26573498.15299.14
120min1261958-26195896.75896.740.9597.9297.900.95
2263822-26382297.44698.60
3264184-26418497.58098.77
4258516-25851695.48696.65
5259287-25928795.77196.89
6263664-26366497.38898.54
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1264389-26438997.65696.431.9298.9897.751.91
2262042-26204296.78998.11
3266597-26659798.47199.82
4254195-25419593.89095.21
5255707-25570794.44995.73
6263512-26351297.33298.64
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