氢氯噻嗪坎地沙坦酯片项目信息
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(%)99.70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%
111.784497604497844496714493114495064496060.05
211.784481624481514481560.01
单位质量响应值RSD%判断
38166.8938043.800.23数据可信
加速6月-供试品溶液-2024082821批-氢氯噻嗪-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1396202-39620274.63869.1615.7674.6469.1615.76
2428405-42840580.70480.70
3268610-26861050.60250.60
4403034-40303475.92575.92
5333797-33379762.88262.88
6372654-37265470.20270.20
10min1450762-45076284.91684.677.8285.0484.797.83
2478625-47862590.16590.30
3389796-38979673.43173.52
4478309-47830990.10690.23
5428098-42809880.64780.75
6471202-47120288.76788.88
15min1467463-46746388.06287.944.6688.3388.204.67
2485191-48519191.40291.69
3433049-43304981.57981.79
4489006-48900692.12192.40
5449699-44969984.71684.96
6476568-47656889.77890.04
20min1474091-47409189.31189.453.8089.7289.853.82
2487345-48734591.80892.24
3446240-44624084.06484.41
4496635-49663593.55893.99
5463302-46330287.27887.66
6481327-48132790.67491.09
30min1480428-48042890.50590.952.4991.0791.512.52
2492331-49233192.74793.34
3464046-46404687.41987.90
4497931-49793193.80294.39
5476827-47682789.82690.35
6485297-48529791.42291.99
45min1484553-48455391.28292.271.6291.9992.971.64
2490505-49050592.40393.15
3477157-47715789.88990.52
4499708-49970894.13794.88
5492722-49272292.82193.50
6494043-49404393.07093.79
60min1485145-48514591.39392.401.5992.2693.261.60
2490486-49048692.39993.30
3480460-48046090.51191.29
4499806-49980694.15595.05
5499382-49938294.07594.91
6487790-48779091.89292.76
极限1519877-51987797.93698.950.8698.9599.960.87
2527399-52739999.353100.41
3521635-52163598.26799.20
4530238-53023899.888100.94
5529837-52983799.813100.80
6522477-52247798.42699.45
氢氯噻嗪坎地沙坦酯片项目信息
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(%)99.80对照品水分(%)0对照品稀释倍数1000
标示量(mg)16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%
115.642916332917272917482915022918402916900.05
215.602911482912822912150.04
单位质量响应值RSD%判断
18650.2618667.630.07数据可信
加速6月-供试品溶液-2024082821批-坎地沙坦酯-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1143849-14384943.27939.4915.0943.2839.4915.09
2150426-15042645.25745.26
398547-9854729.64929.65
4144166-14416643.37443.37
5117352-11735235.30735.31
6133241-13324140.08740.09
10min1217720-21772065.50364.887.9765.5864.947.98
2231953-23195369.78669.86
3185809-18580955.90355.95
4225982-22598267.98968.06
5205973-20597361.96962.03
6226352-22635268.10168.17
15min1252909-25290976.09075.945.1576.2776.125.16
2262321-26232178.92279.11
3231468-23146869.64069.78
4262166-26216678.87679.06
5242550-24255072.97473.14
6263084-26308479.15279.33
20min1269696-26969681.14181.494.0081.4581.794.01
2277516-27751683.49483.82
3254446-25444676.55376.81
4280480-28048084.38684.70
5262092-26209278.85379.14
6280899-28089984.51284.82
30min1283576-28357685.31786.142.7285.7686.582.73
2291305-29130587.64288.10
3275883-27588383.00283.39
4294391-29439188.57189.03
5279467-27946784.08184.50
6293250-29325088.22888.68
45min1289148-28914886.99388.071.8987.5888.651.91
2295697-29569788.96489.57
3285323-28532385.84386.37
4299367-29936790.06890.67
5289472-28947287.09187.65
6297336-29733689.45790.06
60min1289635-28963587.14088.391.7287.8789.121.74
2294804-29480488.69589.45
3286970-28697086.33887.01
4300581-30058190.43391.19
5293014-29301488.15788.86
6297762-29776289.58590.33
极限1304546-30454691.62692.430.7592.5093.300.76
2308364-30836492.77593.68
3305248-30524891.83792.65
4310464-31046493.40794.31
5308574-30857492.83893.69
6306070-30607092.08592.98
氢氯噻嗪坎地沙坦酯片项目信息
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(%)99.70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%
111.784474664476574478394480434484974479000.09
211.784451184456264453720.09
单位质量响应值RSD%判断
38022.0737807.470.41数据可信
加速6月-供试品溶液-2024082821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%
5min1277805-27780552.59756.8412.9052.6056.8412.90
2285266-28526654.01054.01
3342081-34208164.76764.77
4356278-35627867.45567.45
5266166-26616650.39450.39
6273586-27358651.79851.80
10min1401868-40186876.08677.595.0376.1777.685.04
2401433-40143376.00476.09
3414744-41474478.52478.63
4447219-44721984.67384.79
5386201-38620173.12073.20
6407384-40738477.13177.22
15min1433073-43307381.99484.373.0682.2184.603.07
2445859-44585984.41584.63
3442229-44222983.72883.97
4471080-47108089.19089.44
5435068-43506882.37282.58
6446501-44650184.53784.75
20min1453277-45327785.82087.872.2486.1788.232.25
2468248-46824888.65489.01
3458664-45866486.84087.22
4482281-48228191.31191.71
5457602-45760286.63886.98
6464477-46447787.94088.30
30min1476698-47669890.25491.561.6590.7592.081.66
2487315-48731592.26492.77
3477677-47767790.43990.96
4497925-49792594.27394.83
5479930-47993090.86691.35
6482161-48216191.28891.79
45min1490076-49007692.78794.641.4693.4395.301.47
2503673-50367395.36196.02
3495343-49534393.78494.46
4511392-51139296.82397.53
5498867-49886794.45195.09
6499707-49970794.61095.26
60min1496910-49691094.08196.511.3194.8897.331.31
2512779-51277997.08597.90
3508452-50845296.26697.10
4514886-51488697.48498.36
5513477-51347797.21798.01
6511947-51194796.92897.74
极限1526756-52675699.73199.780.74100.69100.760.74
2527865-52786599.941100.92
3521501-52150198.73799.73
4532261-532261100.774101.81
5529670-529670100.283101.24
6523985-52398599.207100.18
氢氯噻嗪坎地沙坦酯片项目信息
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(%)99.80对照品水分(%)0对照品稀释倍数1000
标示量(mg)16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%
115.642911132910132914502914532914812913020.08
215.602900772900192900480.02
单位质量响应值RSD%判断
18625.4518592.820.13数据可信
加速6月-供试品溶液-2024082821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%
5min199309-9930929.95832.3413.1429.9632.3413.14
2102623-10262330.95830.96
3124494-12449437.55637.56
4125640-12564037.90137.90
595531-9553128.81928.82
695654-9565428.85628.86
10min1189991-18999157.31459.026.1057.3659.086.11
2189358-18935857.12357.17
3204896-20489661.81061.87
4215148-21514864.90364.97
5183155-18315555.25255.30
6191365-19136557.72857.78
15min1234929-23492970.87072.893.1371.0273.043.14
2236616-23661671.37971.53
3241554-24155472.86973.03
4255829-25582977.17577.35
5238159-23815971.84571.98
6242704-24270473.21673.36
20min1263185-26318579.39480.811.8679.6681.091.87
2264930-26493079.92180.19
3265277-26527780.02580.31
4276582-27658283.43683.74
5266500-26650080.39480.65
6270844-27084481.70581.97
30min1287916-28791686.85587.771.3187.2588.181.31
2291079-29107987.80988.21
3285479-28547986.11986.54
4296206-29620689.35589.79
5291931-29193188.06688.46
6293037-29303788.39988.80
45min1296998-29699889.59490.741.0990.1491.301.09
2301978-30197891.09791.64
3296389-29638989.41189.97
4303309-30330991.49892.09
5303861-30386191.66592.21
6302239-30223991.17591.73
60min1299266-29926690.27991.631.0190.9792.341.00
2304816-30481691.95392.65
3300819-30081990.74791.46
4305355-30535592.11592.86
5307291-30729192.69993.39
6304884-30488491.97392.68
极限1308951-30895193.20093.060.7694.0493.910.76
2308916-30891693.19094.04
3304713-30471391.92292.79
4311072-31107293.84094.73
5310286-31028693.60394.45
6306885-30688592.57793.43
氢氯噻嗪坎地沙坦酯片项目信息
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(%)99.70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%
111.784460624463794460704460054462444461520.04
211.784442064445014443540.05
单位质量响应值RSD%判断
37873.6837721.050.29数据可信
加速6月-供试品溶液-2024083021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%
5min1346893-34689365.88153.2115.7565.8853.2115.75
2280035-28003553.18453.18
3268885-26888551.06651.07
4212663-21266340.38940.39
5270215-27021551.31951.32
6302357-30235757.42357.42
10min1433477-43347782.32575.857.8382.4475.947.84
2410731-41073178.00678.09
3384441-38444173.01373.10
4359716-35971668.31768.38
5374465-37446571.11871.20
6433606-43360682.35082.45
15min1453948-45394886.21384.404.3786.4684.614.38
2449563-44956385.38085.60
3427323-42732381.15781.36
4433607-43360782.35082.53
5425718-42571880.85281.06
6476113-47611390.42390.66
20min1466315-46631588.56288.283.2188.9588.633.22
2465152-46515288.34188.70
3451610-45161085.76986.11
4463776-46377688.08088.40
5450325-45032585.52585.86
6491733-49173393.38993.77
30min1473252-47325289.87991.802.2490.4292.312.24
2481034-48103491.35791.87
3476978-47697890.58791.07
4485923-48592392.28692.75
5479451-47945191.05791.54
6503675-50367595.65796.20
45min1478527-47852790.88194.732.3691.5795.392.34
2494424-49442493.90094.56
3498549-49854994.68495.32
4508170-50817096.51197.13
5501406-50140695.22695.86
6511744-51174497.19097.89
60min1481474-48147491.44196.172.5792.2896.982.54
2502681-50268195.46996.29
3511742-51174297.18997.98
4515431-51543197.89098.67
5513713-51371397.56498.36
6513229-51322997.47298.33
极限1524495-52449599.61199.590.75100.60100.560.73
2529462-529462100.555101.53
3527947-527947100.267101.22
4522522-52252299.237100.18
5523253-52325399.376100.33
6518698-51869898.51099.53
氢氯噻嗪坎地沙坦酯片项目信息
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(%)99.80对照品水分(%)0对照品稀释倍数1000
标示量(mg)16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%
115.642910962911562911912906132909242909960.09
215.602901432904782903100.09
单位质量响应值RSD%判断
18605.8818609.620.02数据可信
加速6月-供试品溶液-2024083021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%
5min1120039-12003936.21429.0016.0536.2129.0016.05
293448-9344828.19228.19
390428-9042827.28127.28
473499-7349922.17422.17
595153-9515328.70728.71
6104247-10424731.45031.45
10min1203952-20395261.53055.958.4361.5956.008.44
2191050-19105057.63857.68
3177769-17776953.63153.68
4162311-16231148.96749.00
5178116-17811653.73653.78
6199559-19955960.20560.26
15min1241038-24103872.71870.664.7872.8870.804.79
2239133-23913372.14472.29
3225758-22575868.10968.24
4223084-22308467.30267.42
5225347-22534767.98568.12
6251002-25100275.72575.88
20min1262928-26292879.32279.083.4179.6179.343.42
2264958-26495879.93580.20
3254823-25482376.87777.13
4258942-25894278.12078.35
5253246-25324676.40176.65
6277882-27788283.83484.11
30min1279353-27935384.27886.262.3384.6986.652.33
2286013-28601386.28786.68
3282031-28203185.08685.46
4288975-28897587.18187.54
5281569-28156984.94685.32
6297550-29755089.76890.19
45min1286022-28602286.29089.652.2186.8590.192.18
2295360-29536089.10789.65
3297024-29702489.60990.13
4304174-30417491.76692.27
5297109-29710989.63490.15
6303296-30329691.50192.07
60min1287376-28737686.69890.242.0387.4090.932.01
2298038-29803889.91590.60
3302478-30247891.25491.92
4303554-30355491.57992.24
5301096-30109690.83791.51
6302216-30221691.17591.90
极限1306166-30616692.36792.330.5893.2193.160.58
2308552-30855293.08793.93
3307541-30754192.78293.60
4305541-30554192.17892.99
5303865-30386591.67392.49
6304588-30458891.89192.76
氢氯噻嗪坎地沙坦酯片项目信息
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(%)99.70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%
111.784446544446074446544449274451164447920.05
211.784427254429404428320.04
单位质量响应值RSD%判断
37758.2337591.850.32数据可信
加速6月-供试品溶液-2024083021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%
5min1223054-22305442.50047.9411.4742.5047.9411.47
2290709-29070955.39055.39
3238055-23805545.35845.36
4232650-23265044.32844.33
5239762-23976245.68345.68
6285304-28530454.36154.36
10min1393891-39389175.05079.974.4975.1280.054.49
2431121-43112182.14482.24
3413009-41300978.69378.77
4404168-40416877.00877.08
5435433-43543382.96583.04
6440627-44062783.95584.05
15min1455956-45595686.87690.172.4787.0790.382.48
2473971-47397190.30890.54
3464979-46497988.59588.80
4473777-47377790.27190.47
5482201-48220191.87692.09
6488542-48854293.08593.32
20min1486243-48624392.64793.811.5692.9994.181.57
2490524-49052493.46293.84
3483274-48327492.08192.44
4491451-49145193.63993.99
5503519-50351995.93896.31
6499100-49910095.09695.48
30min1507935-50793596.78096.691.1597.2797.211.15
2504544-50454496.13496.67
3499224-49922495.12095.63
4505794-50579496.37296.88
5516070-51607098.33098.86
6511321-51132197.42597.97
45min1525395-525395100.10699.231.03100.7699.911.02
2519645-51964599.01199.71
3510866-51086697.33898.00
4521557-52155799.375100.04
5524953-524953100.022100.71
6522469-52246999.549100.26
60min1534319-534319101.807100.380.95102.63101.230.94
2527587-527587100.524101.38
3518838-51883898.85799.69
4527700-527700100.546101.38
5527436-527436100.495101.35
6525232-525232100.075100.95
极限1542645-542645103.393100.891.33104.39101.901.31
2529729-529729100.932101.96
3526695-526695100.354101.35
4529763-529763100.939101.94
5525969-525969100.216101.24
6522197-52219799.497100.54
氢氯噻嗪坎地沙坦酯片项目信息
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(%)99.80对照品水分(%)0对照品稀释倍数1000
标示量(mg)16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%
115.642903762906212905312901672905302904450.07
215.602899322898832899080.02
单位质量响应值RSD%判断
18570.6518583.850.06数据可信
加速6月-供试品溶液-2024083021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%
5min173389-7338922.17725.1012.0122.1825.1012.01
297741-9774129.53629.54
377661-7766123.46823.47
476933-7693323.24823.25
579244-7924423.94623.95
693393-9339328.22228.22
10min1171258-17125851.75155.375.4551.7955.415.45
2194595-19459558.80458.85
3175810-17581053.12753.17
4177541-17754153.65053.69
5185474-18547456.04756.09
6194737-19473758.84658.89
15min1228496-22849669.04872.673.6069.1772.803.60
2245819-24581974.28374.43
3232949-23294970.39470.52
4241784-24178473.06373.19
5241411-24141172.95173.08
6252384-25238476.26676.41
20min1263615-26361579.66082.052.3579.9082.312.36
2273184-27318482.55282.82
3263928-26392879.75580.00
4274139-27413982.84083.09
5274991-27499183.09883.35
6279318-27931884.40584.68
30min1294195-29419588.90189.701.1289.2790.091.13
2298469-29846990.19390.60
3291333-29133388.03688.41
4298506-29850690.20490.59
5298672-29867290.25490.65
6299791-29979190.59291.00
45min1308948-30894893.35992.560.8693.8893.100.85
2306160-30616092.51793.08
3301536-30153691.11991.64
4307747-30774792.99693.53
5307659-30765992.97093.51
6305778-30577892.40192.97
60min1312673-31267394.48593.140.9495.1693.840.93
2308100-30810093.10393.82
3304049-30404991.87992.56
4308871-30887193.33694.03
5309103-30910393.40694.10
6306516-30651692.62493.34
极限1313357-31335794.69293.570.8095.5294.420.78
2309929-30992993.65694.52
3308624-30862493.26194.09
4310813-31081393.92394.77
5309153-30915393.42194.28
6305976-30597692.46193.33
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