氢氯噻嗪缬沙坦片项目信息
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H220807-2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2000
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%
114.022566572567902565892567452564812566520.05
214.082570152573422571780.09
单位质量响应值RSD%判断
18306.1318265.480.16数据可信
供试品溶液-24121903批-氢氯噻嗪-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%
5min1359807-35980770.19970.231.1970.2070.231.19
2361016-36101670.43570.44
3364832-36483271.18071.18
4364054-36405471.02871.03
5355818-35581869.42169.42
6354285-35428569.12269.12
10min1441106-44110686.06186.481.0086.1886.591.00
2442611-44261186.35486.47
3447305-44730587.27087.39
4449075-44907587.61687.73
5442551-44255186.34386.46
6436769-43676985.21585.33
15min1469906-46990691.68091.560.9791.9491.830.97
2466641-46664191.04391.30
3472635-47263592.21292.48
4474496-47449692.57592.84
5470363-47036391.76992.03
6461860-46186090.11090.37
20min1479150-47915093.48393.541.0793.9093.951.07
2477373-47737393.13793.55
3482507-48250794.13894.56
4485133-48513394.65195.07
5481879-48187994.01694.43
6470526-47052691.80192.21
30min1488822-48882295.37095.171.1295.9495.741.12
2486218-48621894.86295.43
3489104-48910495.42596.00
4492881-49288196.16296.74
5491852-49185295.96196.53
6477815-47781593.22393.78
45min1493666-49366696.31595.621.3597.0496.351.34
2489419-48941995.48796.21
3484094-48409494.44895.18
4496134-49613496.79797.53
5496671-49667196.90297.63
6480699-48069993.78694.50
60min1496670-49667096.90196.401.3097.7997.291.30
2492535-49253596.09596.98
3495120-49512096.59997.49
4498531-49853197.26598.16
5499717-49971797.49698.39
6482095-48209594.05894.93
90min1497010-49701096.96896.801.4098.0297.851.40
2493908-49390896.36397.41
3497158-49715896.99798.05
4501880-50188097.91898.98
5503228-50322898.18199.23
6483861-48386194.40295.43
120min1498393-49839397.23897.021.6198.4598.221.60
2492371-49237196.06397.27
3498494-49849497.25798.47
4504391-50439198.40899.63
5505671-50567198.65899.87
6484243-48424394.47795.66
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1516303-516303100.732100.381.80102.11101.751.79
2512142-51214299.920101.29
3515304-515304100.537101.91
4516992-516992100.866102.25
5527345-527345102.886104.27
6498822-49882297.32198.67
氢氯噻嗪缬沙坦片项目信息
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67824040658对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.4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%
117.916840406847966847336839226843826843750.06
217.886872846875886874360.04
单位质量响应值RSD%判断
38211.8938447.200.44数据可信
供试品溶液-24121903批-缬沙坦-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%
5min1274041-27404139.97640.042.0839.9840.042.08
2270295-27029539.42939.43
3280923-28092340.97940.98
4282096-28209641.15141.15
5269311-26931139.28639.29
6270185-27018539.41339.41
10min1412791-41279160.21661.422.0360.2861.482.04
2413833-41383360.36860.43
3431284-43128462.91362.98
4432093-43209363.03163.10
5418685-41868561.07561.14
6417519-41751960.90560.97
15min1505598-50559873.75474.301.8273.9274.471.82
2497544-49754472.57972.75
3517590-51759075.50375.68
4522628-52262876.23876.41
5508992-50899274.24974.42
6503766-50376673.48773.65
20min1561897-56189781.96682.781.3682.2683.081.36
2558793-55879381.51481.80
3574222-57422283.76484.06
4578829-57882984.43684.74
5567524-56752482.78783.08
6563773-56377382.24082.53
30min1630124-63012491.91992.211.1092.3592.641.10
2624301-62430191.07091.49
3636272-63627292.81693.25
4643516-64351693.87394.31
5631589-63158992.13392.56
6626922-62692291.45291.88
45min1666744-66674497.26197.210.9897.8497.790.98
2660121-66012196.29596.87
3658533-65853396.06396.66
4676305-67630598.65699.25
5670050-67005097.74398.33
6666469-66646997.22197.80
60min1681889-68188999.47099.360.88100.21100.110.88
2672084-67208498.04098.78
3682417-68241799.547100.30
4689399-689399100.566101.33
5684035-68403599.783100.53
6676926-67692698.74699.49
90min1680211-68021199.22599.690.95100.13100.600.95
2673852-67385298.29899.20
3685124-68512499.942100.86
4692515-692515101.020101.95
5687309-687309100.261101.17
6681338-68133899.390100.30
120min1680027-68002799.19999.621.01100.27100.701.01
2672753-67275398.13799.20
3684150-68415099.800100.89
4693045-693045101.098102.20
5686862-686862100.196101.27
6680769-68076999.307100.38
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1681481-68148199.41199.680.97100.65100.930.98
2673783-67378398.28899.51
3683283-68328399.674100.93
4692902-692902101.077102.34
5688301-688301100.406101.65
6680374-68037499.249100.49
氢氯噻嗪缬沙坦片项目信息
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H220807-2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2000
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%
114.022577542577732576612574142571192575440.11
214.082574862574402574630.02
单位质量响应值RSD%判断
18369.7618285.720.33数据可信
供试品溶液-24121904批-氢氯噻嗪-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%
5min1358902-35890269.86369.082.2769.8669.082.26
2354148-35414868.93768.94
3354795-35479569.06369.06
4339893-33989366.16266.16
5358393-35839369.76469.76
6363123-36312370.68470.68
10min1441989-44198986.03684.591.8986.1584.701.89
2430257-43025783.75283.87
3435897-43589784.85084.97
4420026-42002681.76181.87
5439287-43928785.51085.63
6439816-43981685.61385.73
15min1469931-46993191.47589.072.1891.7489.332.17
2453679-45367988.31288.57
3462093-46209389.95090.21
4442790-44279086.19286.44
5464961-46496190.50890.77
6451952-45195287.97688.24
20min1481034-48103493.63791.482.1094.0591.892.10
2464300-46430090.37990.78
3473874-47387492.24392.65
4453089-45308988.19788.59
5474326-47432692.33192.74
6473200-47320092.11292.52
30min1490194-49019495.42093.002.2895.9993.562.28
2470277-47027791.54392.09
3482523-48252393.92694.49
4459751-45975189.49490.03
5481262-48126293.68194.24
6482522-48252293.92694.49
45min1495023-49502396.36093.212.5097.0993.922.50
2474912-47491292.44593.15
3486541-48654194.70895.43
4461205-46120589.77790.46
5483411-48341194.09994.82
6472046-47204691.88792.60
60min1498129-49812996.96494.162.3397.8595.032.33
2477306-47730692.91193.77
3489538-48953895.29296.17
4465306-46530690.57591.41
5485030-48503094.41495.29
6487150-48715094.82795.70
90min1501109-50110997.54494.642.4498.5995.662.43
2479954-47995493.42694.44
3491673-49167395.70796.74
4466496-46649690.80791.79
5490304-49030495.44196.47
6487560-48756094.90795.94
120min1501177-50117797.55794.542.4998.7795.722.49
2478756-47875693.19394.36
3492494-49249495.86797.06
4466062-46606290.72291.86
5488614-48861495.11296.30
6486810-48681094.76195.95
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1515587-515587100.36297.372.81101.7498.712.81
2493930-49393096.14797.47
3508714-50871499.025100.38
4475711-47571192.60093.89
5506363-50636398.56799.92
6500907-50090797.50598.85
氢氯噻嗪缬沙坦片项目信息
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67824040658对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.4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%
117.916876756877606876896867866852806870380.16
217.886878506882856880680.05
单位质量响应值RSD%判断
38360.5838482.550.23数据可信
供试品溶液-24121904批-缬沙坦-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%
5min1277141-27714140.33141.274.0140.3341.274.00
2287658-28765841.86141.86
3287701-28770141.86741.87
4265560-26556038.64538.65
5284248-28424841.36541.36
6299193-29919343.54043.54
10min1432089-43208962.87962.342.4962.9562.412.49
2427155-42715562.16162.23
3428513-42851362.35962.43
4409738-40973859.62759.69
5430338-43033862.62562.69
6442527-44252764.39864.47
15min1522082-52208275.97674.371.8676.1574.541.86
2513733-51373374.76174.93
3512521-51252174.58474.76
4496258-49625872.21872.38
5517842-51784275.35875.53
6503667-50366773.29673.48
20min1578561-57856184.19583.021.8184.4983.311.81
2568528-56852882.73583.03
3567674-56767482.61082.91
4553092-55309280.48880.77
5572243-57224383.27583.57
6582643-58264384.78985.09
30min1642555-64255593.50791.482.1993.9591.912.20
2624005-62400590.80891.24
3629609-62960991.62392.06
4605099-60509988.05688.47
5628422-62842291.45191.89
6641943-64194393.41893.86
45min1678142-67814298.68696.191.6299.2896.771.61
2662141-66214196.35796.94
3663139-66313996.50397.09
4645442-64544293.92794.49
5660962-66096296.18696.78
6656000-65600095.46496.06
60min1689293-689293100.30998.481.50101.0799.231.51
2674244-67424498.11998.87
3676540-67654098.45399.20
4661421-66142196.25396.97
5672314-67231497.83898.59
6686479-68647999.899100.66
90min1691386-691386100.61398.781.50101.5499.691.50
2676804-67680498.49199.40
3677246-67724698.55699.47
4662553-66255396.41797.30
5676873-67687398.50199.41
6687980-687980100.118101.04
120min1687858-687858100.10098.671.33101.1999.741.33
2677495-67749598.59299.67
3677383-67738398.57699.65
4662599-66259996.42497.47
5676626-67662698.46599.54
6686182-68618299.856100.95
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1685800-68580099.80098.741.29101.0699.981.30
2675978-67597898.37199.61
3677133-67713398.53999.78
4663570-66357096.56597.77
5680538-68053899.035100.28
6688159-688159100.144101.40
氢氯噻嗪缬沙坦片项目信息
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H220807-2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2000
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%
114.022569732569482569352571192569662569880.03
214.082587322591062589190.11
单位质量响应值RSD%判断
18330.1018389.130.23数据可信
供试品溶液-TERT7批-氢氯噻嗪-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%
5min1240218-24021846.67949.704.3446.6849.704.34
2254606-25460649.47549.47
3255909-25590949.72849.73
4249694-24969448.52048.52
5260938-26093850.70550.71
6273292-27329253.10653.11
10min1369755-36975571.85073.232.7471.9373.312.74
2373222-37322272.52472.61
3369361-36936171.77471.86
4374085-37408572.69272.77
5377728-37772873.39973.48
6396903-39690377.12677.21
15min1433997-43399784.33484.981.7984.5385.191.79
2432285-43228584.00184.20
3431799-43179983.90684.11
4434478-43447884.42784.63
5439091-43909185.32385.53
6452371-45237187.90488.12
20min1468238-46823890.98791.101.0791.3391.441.07
2467011-46701190.74991.09
3465203-46520390.39790.74
4466271-46627190.60590.95
5467310-46731090.80791.16
6478770-47877093.03493.40
30min1495232-49523296.23396.550.7396.7297.040.74
2497999-49799996.77097.26
3493049-49304995.80896.30
4494222-49422296.03696.53
5497463-49746396.66697.17
6503133-50313397.76898.29
45min1510138-51013899.12999.260.6599.7899.920.65
2513112-51311299.707100.36
3506283-50628398.38099.03
4508281-50828198.76899.42
5511841-51184199.460100.12
6515332-515332100.138100.82
60min1512654-51265499.61899.860.57100.43100.680.58
2516963-516963100.455101.28
3510078-51007899.11799.93
4512149-51214999.520100.34
5513903-51390399.861100.69
6517604-517604100.580101.43
90min1516416-516416100.349100.300.60101.33101.280.60
2520094-520094101.064102.05
3512403-51240399.569100.55
4513210-51321099.726100.71
5515655-515655100.201101.19
6519070-519070100.865101.88
120min1514183-51418399.915100.030.55101.06101.190.55
2518888-518888100.829101.99
3512018-51201899.494100.64
4512092-51209299.509100.66
5514117-51411799.902101.06
6517375-517375100.535101.72
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1512702-51270299.62799.900.56100.94101.220.57
2517267-517267100.514101.84
3512360-51236099.561100.87
4510687-51068799.236100.55
5513651-51365199.812101.14
6517865-517865100.631101.98
氢氯噻嗪缬沙坦片项目信息
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67824040658对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.4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%
117.916864446861336861226865806856096861780.06
217.886932386936456934420.05
单位质量响应值RSD%判断
38312.5638783.110.87数据可信
供试品溶液-TERT7批-缬沙坦-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%
5min1173939-17393925.23028.486.8825.2328.486.88
2195746-19574628.39328.39
3195829-19582928.40528.41
4195323-19532328.33228.33
5201172-20117229.18029.18
6215938-21593831.32231.32
10min1319768-31976846.38348.065.7246.4348.115.72
2323743-32374346.96047.01
3314510-31451045.62045.67
4328547-32854747.65747.70
5334171-33417148.47248.52
6367435-36743553.29753.35
15min1418044-41804460.63861.954.3760.7662.084.37
2411961-41196159.75659.88
3411433-41143359.67959.80
4428093-42809362.09662.22
5432019-43201962.66562.79
6461092-46109266.88367.02
20min1491124-49112471.23971.812.8171.4672.042.82
2482060-48206069.92470.15
3483818-48381870.17970.40
4497086-49708672.10472.33
5495782-49578271.91472.15
6520551-52055175.50775.76
30min1576833-57683383.67184.421.8984.0184.771.90
2571747-57174782.93383.28
3571524-57152482.90183.24
4586792-58679285.11685.47
5584952-58495284.84985.20
6600144-60014487.05287.43
45min1641729-64172993.08493.411.1693.5693.901.17
2638202-63820292.57393.05
3633069-63306991.82892.31
4650191-65019194.31294.80
5648820-64882094.11394.61
6651659-65165994.52595.05
60min1668443-66844396.95996.971.0497.5997.621.04
2665391-66539196.51797.15
3657102-65710295.31495.95
4677764-67776498.31198.96
5671148-67114897.35298.00
6671230-67123097.36498.04
90min1684033-68403399.22199.310.96100.02100.120.96
2687267-68726799.690100.48
3672812-67281297.59398.38
4691708-691708100.334101.15
5688587-68858799.881100.70
6683500-68350099.14399.99
120min1687935-68793599.78799.640.94100.75100.610.93
2691368-691368100.285101.25
3675141-67514197.93198.88
4693120-693120100.539101.52
5688728-68872899.902100.88
6685131-68513199.380100.39
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1686581-68658199.59099.640.94100.72100.780.93
2692834-692834100.497101.63
3675557-67555797.99199.11
4692482-692482100.446101.59
5689383-68938399.997101.14
6684689-68468999.316100.49
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