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(%)99.7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%
111.924634324636194636764635754636784635960.03
211.984624694629804627240.08
单位质量响应值RSD%判断
38892.2838624.710.49数据可信
加速6月-供试品溶液-2024082321批-氢氯噻嗪坎-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%
5min1426757-42675779.04065.0213.7179.0465.0213.71
2344278-34427863.76463.76
3321350-32135059.51759.52
4352591-35259165.30465.30
5285472-28547252.87252.87
6375912-37591269.62369.62
10min1497916-49791692.21985.655.1192.3585.765.11
2446361-44636182.67182.78
3453183-45318383.93484.03
4446881-44688182.76782.88
5443728-44372882.18382.27
6486728-48672890.14790.26
15min1508407-50840794.16290.543.0594.4590.803.06
2475330-47533088.03688.28
3482380-48238089.34289.58
4478460-47846088.61688.86
5481482-48148289.17689.40
6507181-50718193.93594.20
20min1509610-50961094.38592.182.1794.8392.592.19
2487852-48785290.35590.75
3492011-49201191.12691.51
4488649-48864990.50390.90
5495540-49554091.77992.15
6512692-51269294.95695.38
30min1513558-51355895.11694.191.3695.7294.751.38
2501534-50153492.88993.43
3506946-50694693.89294.43
4501612-50161292.90493.45
5508521-50852194.18394.71
6519226-51922696.16696.75
45min1517448-51744895.83795.940.8996.6096.650.89
2510874-51087494.61995.32
3521083-52108396.51097.21
4515360-51536095.45096.15
5519176-51917696.15796.84
6523930-52393097.03797.78
60min1521196-52119696.53197.000.8997.4597.870.88
2516500-51650095.66196.52
3529748-52974898.11598.97
4524820-52482097.20298.06
5523020-52302096.86997.71
6526960-52696097.59998.50
极限1534886-53488699.06798.400.83100.1599.430.82
2525848-52584897.39398.41
3536423-53642399.351100.37
4533338-53333898.78099.80
5530568-53056898.26799.27
6526599-52659997.53298.60
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(%)99.8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%
116.461533391531351535251532051530181532440.13
216.421532651530521531580.10
单位质量响应值RSD%判断
9310.099327.530.14数据可信
加速6月-供试品溶液-2024082321批-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%
5min183990-8399050.59742.1413.6250.6042.1413.62
269981-6998142.15742.16
364202-6420238.67638.68
471302-7130242.95342.95
555773-5577333.59833.60
674454-7445444.85244.85
10min1121536-12153673.21568.315.4173.3068.385.42
2108282-10828265.23065.30
3111480-11148067.15767.22
4113304-11330468.25668.33
5106106-10610663.91963.98
6119633-11963372.06872.14
15min1135831-13583181.82679.483.1282.0379.663.13
2126886-12688676.43876.62
3130654-13065478.70778.88
4131982-13198279.50779.69
5128692-12869277.52677.69
6137553-13755382.86383.06
20min1142883-14288386.07484.712.0586.4285.032.06
2136389-13638982.16282.47
3139884-13988484.26884.58
4140698-14069884.75885.08
5139270-13927083.89884.19
6144591-14459187.10387.44
30min1149849-14984990.27189.701.0590.7690.161.06
2146306-14630688.13688.58
3149516-14951690.07090.52
4149003-14900389.76190.22
5148058-14805889.19289.62
6150719-15071990.79591.27
45min1153209-15320992.29592.110.9592.9392.710.96
2150180-15018090.47091.06
3153950-15395092.74193.34
4153492-15349292.46593.07
5152468-15246891.84892.43
6154080-15408092.82093.45
60min1155175-15517593.47993.040.8294.2793.800.83
2152327-15232791.76492.50
3155969-15596993.95894.71
4154541-15454193.09793.86
5153832-15383292.67093.40
6154822-15482293.26794.05
极限1157464-15746494.85894.210.7895.8095.120.78
2154437-15443793.03593.93
3157745-15774595.02795.94
4156743-15674394.42495.34
5155822-15582293.86994.76
6156096-15609694.03494.97
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(%)99.7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%
111.924616714614214613444614294611794614090.04
211.984596994599514598250.04
单位质量响应值RSD%判断
38708.8138382.720.60数据可信
加速6月-供试品溶液-2024082521批-氢氯噻嗪坎
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1292124-29212454.40361.5810.1354.4061.5810.14
2287336-28733653.51253.51
3336009-33600962.57662.58
4360827-36082767.19867.20
5343174-34317463.91163.91
6364613-36461367.90367.90
10min1407329-40732975.85881.294.2975.9581.394.29
2422034-42203478.59778.69
3435212-43521281.05181.16
4454777-45477784.69584.81
5450603-45060383.91884.02
6448907-44890783.60283.71
15min1435274-43527481.06385.813.1881.2886.053.19
2453546-45354684.46684.69
3461578-46157885.96186.20
4471739-47173987.85488.11
5475017-47501788.46488.71
6467414-46741487.04887.30
20min1448501-44850183.52687.852.6583.8888.242.65
2470321-47032187.59087.95
3474366-47436688.34388.73
4477228-47722888.87689.28
5485480-48548090.41390.81
6474493-47449388.36788.76
30min1465734-46573486.73590.482.3987.2391.002.39
2491532-49153291.54092.05
3490267-49026791.30491.83
4485373-48537390.39390.94
5499956-49995693.10993.65
6482108-48210889.78590.33
45min1477939-47793989.00892.432.7489.6493.112.73
2508201-50820194.64495.30
3503296-50329693.73194.41
4490511-49051191.35092.05
5512095-51209595.36996.07
6485826-48582690.47791.17
60min1483383-48338390.02293.222.9790.8194.062.95
2515698-51569896.04096.86
3507836-50783694.57695.41
4493189-49318991.84992.70
5516925-51692596.26997.13
6486440-48644090.59291.44
极限1528433-52843398.41298.971.2699.3599.951.26
2526511-52651198.05499.03
3540251-540251100.613101.61
4530621-53062198.82099.82
5538816-538816100.346101.36
6523841-52384197.55798.55
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(%)99.8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%
116.461528181525791524771528581526921526850.11
216.421529251528351528800.05
单位质量响应值RSD%判断
9276.129310.600.27数据可信
加速6月-供试品溶液-2024082521批-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%
5min158040-5804035.06039.4110.1935.0639.4110.19
256295-5629534.00634.01
366468-6646840.15140.15
472155-7215543.58643.59
567316-6731640.66340.66
671186-7118643.00143.00
10min1100375-10037560.63364.334.3160.6964.404.32
2100948-10094860.97961.04
3108111-10811165.30665.37
4110148-11014866.53666.61
5110054-11005466.47966.55
6109380-10938066.07266.14
15min1117595-11759571.03574.603.1271.1974.783.13
2119999-11999972.48772.65
3125890-12589076.04576.22
4124407-12440775.15075.33
5127440-12744076.98277.16
6125693-12569375.92676.11
20min1126924-12692476.67080.262.9076.9580.562.90
2130271-13027178.69278.97
3135185-13518581.66081.96
4132630-13263080.11780.43
5137750-13775083.21083.52
6134472-13447281.22981.54
30min1135954-13595482.12585.942.6882.5386.372.68
2142943-14294386.34686.76
3144966-14496687.56988.01
4140772-14077285.03585.48
5146993-14699388.79389.24
6141988-14198885.77086.21
45min1142197-14219785.89689.032.5386.4489.602.52
2149755-14975590.46191.02
3149745-14974590.45591.04
4145044-14504487.61688.20
5152069-15206991.85992.45
6145484-14548487.88188.47
60min1144185-14418587.09790.062.6387.7890.782.62
2151526-15152691.53192.24
3151816-15181691.70692.44
4146706-14670688.62089.35
5154087-15408793.07893.82
6146191-14619188.30889.04
极限1155336-15533693.83394.311.3294.6695.181.33
2154407-15440793.27194.13
3158576-15857695.79096.68
4155706-15570694.05694.93
5158738-15873895.88896.79
6153998-15399893.02493.90
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(%)99.7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%
111.924602014602084602294599634600404601280.03
211.984596194599294597740.05
单位质量响应值RSD%判断
38601.3438378.460.41数据可信
加速6月-供试品溶液-2024082721批-氢氯噻嗪坎
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1295694-29569455.14853.8711.7155.1553.8711.71
2277790-27779051.80951.81
3295069-29506955.03155.03
4249468-24946846.52646.53
5267151-26715149.82449.82
6347877-34787764.88064.88
10min1415147-41514777.42679.638.0777.5279.728.08
2403786-40378675.30775.39
3430878-43087880.36080.45
4397159-39715974.07174.15
5422119-42211978.72678.81
6492743-49274391.89892.01
15min1475158-47515888.61888.214.4888.8488.434.49
2454519-45451984.76984.98
3479724-47972489.47089.70
4449369-44936983.80884.01
5470108-47010887.67687.89
6508820-50882094.89695.16
20min1489591-48959191.31090.793.3191.6891.163.32
2472654-47265488.15188.50
3492668-49266891.88492.26
4468831-46883187.43887.78
5483448-48344890.16490.52
6513569-51356995.78296.20
30min1503675-50367593.93793.542.5894.4694.062.60
2488915-48891591.18491.68
3510423-51042395.19595.72
4486636-48663690.75991.25
5498958-49895893.05793.57
6520547-52054797.08397.66
45min1531456-53145699.11897.151.7699.8097.831.78
2513970-51397095.85796.51
3527034-52703498.29398.98
4507659-50765994.68095.32
5518116-51811696.63097.30
6527132-52713298.31199.05
60min1528470-52847098.56198.171.2499.4099.011.24
2517842-51784296.57997.39
3536135-53613599.990100.84
4520862-52086297.14297.94
5529116-52911698.68199.51
6525878-52587898.07898.98
极限1530640-53064098.96698.841.3499.9799.841.33
2520450-52045097.06598.04
3540923-540923100.883101.90
4529822-52982298.81399.77
5533315-53331599.465100.46
6524664-52466497.85198.92
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(%)99.8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%
116.461529591531311532821528791531991530900.11
216.421530341533201531770.14
单位质量响应值RSD%判断
9300.739328.680.22数据可信
加速6月-供试品溶液-2024082721批-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%
5min158394-5839435.19334.619.7935.1934.609.80
255272-5527233.31133.31
358045-5804534.98234.98
450061-5006130.17130.17
555599-5559933.50833.51
667144-6714440.46640.47
10min1106040-10604063.90864.225.8663.9764.285.86
2101906-10190661.41661.47
3106355-10635564.09864.16
4100541-10054160.59460.64
5106291-10629164.05964.12
6118235-11823571.25871.32
15min1128836-12883677.64777.443.7477.8177.603.75
2122728-12272873.96574.12
3129396-12939677.98478.15
4124069-12406974.77474.92
5129718-12971878.17878.34
6136232-13623282.10482.29
20min1139199-13919983.89283.492.2884.1983.782.29
2133262-13326280.31480.60
3139775-13977584.23984.53
4136595-13659582.32382.60
5140102-14010284.43684.73
6142246-14224685.72886.05
30min1148639-14863989.58189.091.7390.0289.531.74
2143556-14355686.51886.93
3149984-14998490.39290.83
4145915-14591587.94088.35
5149354-14935490.01290.45
6149529-14952990.11890.58
45min1155205-15520593.53992.581.4194.1293.161.41
2149928-14992890.35890.92
3155790-15579093.89194.48
4152382-15238291.83792.40
5154464-15446493.09293.68
6153872-15387292.73593.35
60min1155508-15550893.72193.371.2694.4694.111.26
2151860-15186091.52392.23
3157479-15747994.90995.65
4154000-15400092.81293.53
5156154-15615494.11094.85
6154557-15455793.14893.92
极限1157396-15739694.85994.311.3495.7595.201.34
2153372-15337292.43493.30
3159476-15947696.11397.01
4155282-15528293.58594.45
5157330-15733094.81995.71
6156075-15607594.06394.99
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(%)99.7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%
111.924583534581344576144573614570204576960.12
211.984561114559074560090.04
单位质量响应值RSD%判断
38397.3238064.190.62数据可信
加速6月-供试品溶液-2024082321批-氢氯噻嗪坎
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1300053-30005356.34161.949.8556.3461.949.86
2306232-30623257.50157.50
3354715-35471566.60466.60
4295267-29526755.44255.44
5359440-35944067.49267.49
6363666-36366668.28568.29
10min1395993-39599374.35577.994.9174.4578.094.91
2404712-40471275.99276.09
3429682-42968280.68180.79
4391232-39123273.46173.55
5437703-43770382.18782.30
6432653-43265381.23981.35
15min1431301-43130180.98582.902.7181.2083.142.72
2428033-42803380.37180.59
3450202-45020284.53484.78
4433899-43389981.47381.69
5457178-45717885.84486.09
6448519-44851984.21884.47
20min1448487-44848784.21285.552.1084.5685.922.11
2440413-44041382.69683.05
3461900-46190086.73087.12
4456773-45677385.76886.12
5466484-46648487.59187.98
6459522-45952286.28486.67
30min1471285-47128588.49388.401.6788.9988.911.67
2456463-45646385.70986.20
3474168-47416889.03489.56
4477536-47753689.66690.16
5476917-47691789.55090.09
6468252-46825287.92388.46
45min1489589-48958991.92990.581.9292.5791.241.91
2468552-46855287.97988.62
3482811-48281190.65791.34
4493158-49315892.60093.24
5485514-48551491.16491.85
6474686-47468689.13189.81
60min1498879-49887993.67491.562.1994.4792.372.17
2474082-47408289.01889.80
3486068-48606891.26892.10
4499569-49956993.80394.60
5489798-48979891.96992.81
6477184-47718489.60090.43
极限1525633-52563398.69797.540.7199.6598.510.69
2516025-51602596.89397.83
3517391-51739197.15098.13
4522109-52210998.03698.99
5517478-51747897.16698.16
6518259-51825997.31398.29
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(%)99.8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%
116.461533931538111537421537161534441536210.13
216.421530941533931532440.14
单位质量响应值RSD%判断
9332.999332.760.01数据可信
加速6月-供试品溶液-2024082321批-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%
5min162407-6240737.53841.949.6337.5441.949.63
264106-6410638.56038.56
374653-7465344.90444.90
464535-6453538.81838.82
577307-7730746.50046.50
675323-7532345.30745.31
10min1105016-10501663.16765.464.8263.2365.534.83
2106710-10671064.18664.25
3112711-11271167.79667.87
4101302-10130260.93361.00
5114343-11434368.77868.86
6112864-11286467.88867.96
15min1123404-12340474.22875.782.5674.4075.962.57
2123632-12363274.36574.54
3128258-12825877.14877.34
4122299-12229973.56373.73
5129876-12987678.12178.31
6128396-12839677.23177.42
20min1133079-13307980.04781.121.7980.3481.421.80
2131780-13178079.26679.56
3136600-13660082.16582.48
4133336-13333680.20280.49
5137358-13735882.62182.94
6137012-13701282.41382.73
30min1142903-14290385.95785.931.1686.3886.371.16
2139829-13982984.10884.53
3143120-14312086.08786.54
4144423-14442386.87187.29
5144196-14419686.73487.19
6142704-14270485.83786.29
45min1148818-14881889.51488.341.3990.0888.921.38
2143812-14381286.50387.07
3146489-14648988.11488.71
4149185-14918589.73590.30
5147384-14738488.65289.26
6145527-14552787.53588.13
60min1151324-15132491.02289.371.6091.7490.101.58
2145286-14528687.39088.10
3148144-14814489.10989.85
4150811-15081190.71391.43
5149295-14929589.80190.55
6146603-14660388.18288.93
极限1155630-15563093.61293.030.6694.4893.920.65
2153396-15339692.26893.13
3154191-15419192.74693.64
4156057-15605793.86994.74
5154048-15404892.66093.56
6154693-15469393.04893.94
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(%)99.7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%
111.924554904554584552024550224549744552290.06
211.984533254536574534910.06
单位质量响应值RSD%判断
38190.3537854.010.63数据可信
加速6月-供试品溶液-2024082521批-氢氯噻嗪坎
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1273262-27326251.59251.749.6851.5951.749.68
2277083-27708352.31352.31
3251744-25174447.52947.53
4271406-27140651.24151.24
5248331-24833146.88546.88
6322401-32240160.86960.87
10min1437496-43749682.59976.415.6582.6876.505.65
2408340-40834077.09477.18
3390662-39066273.75773.84
4388379-38837973.32573.41
5378910-37891071.53871.62
6424587-42458780.16280.26
15min1473166-47316689.33385.223.1189.5685.443.11
2453662-45366285.65185.87
3448582-44858284.69284.89
4435272-43527282.17982.39
5438329-43832982.75682.95
6459316-45931686.71886.95
20min1483783-48378391.33889.332.0191.7189.682.01
2474447-47444789.57589.93
3478431-47843190.32790.67
4455729-45572986.04186.39
5471606-47160689.03989.37
6474846-47484689.65090.03
30min1496915-49691593.81793.171.6794.3493.681.66
2497157-49715793.86394.37
3502290-50229094.83295.33
4478222-47822290.28890.78
5493273-49327393.12993.61
6493069-49306993.09193.62
45min1508003-50800395.91095.751.3696.5996.411.36
2512234-51223496.70997.37
3513882-51388297.02097.67
4494358-49435893.33493.97
5506293-50629395.58796.23
6508088-50808895.92696.61
60min1514838-51483897.20196.931.2598.0497.751.25
2517388-51738897.68298.51
3518985-51898597.98498.80
4500980-50098094.58495.38
5514040-51404097.05097.85
6514108-51410897.06397.91
极限1519416-51941698.06598.901.2899.0799.881.27
2526463-52646399.396100.38
3531939-531939100.429101.41
4513246-51324696.90097.85
5528129-52812999.710100.67
6523975-52397598.92699.93
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(%)99.8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%
116.461528661529521528641528041529721528920.05
216.421527701528291528000.03
单位质量响应值RSD%判断
9288.709305.720.13数据可信
加速6月-供试品溶液-2024082521批-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%
5min155372-5537233.43433.089.6433.4333.089.64
255336-5533633.41233.41
349526-4952629.90429.90
454358-5435832.82232.82
549991-4999130.18530.19
664158-6415838.73938.74
10min1105405-10540563.64558.956.6663.7059.006.66
298216-9821659.30459.36
391303-9130355.13055.18
495807-9580757.84957.90
590191-9019154.45854.51
6104829-10482963.29763.36
15min1126936-12693676.64572.394.1876.8172.544.18
2119827-11982772.35372.51
3115776-11577669.90770.05
4117135-11713570.72770.88
5114764-11476469.29669.44
6124849-12484975.38575.56
20min1137606-13760683.08880.732.1883.3881.002.19
2133952-13395280.88281.16
3131825-13182579.59779.86
4129794-12979478.37178.64
5132639-13263980.08980.35
6136359-13635982.33582.63
30min1147717-14771789.19388.331.3989.6288.741.39
2146488-14648888.45188.86
3147640-14764089.14789.54
4142289-14228985.91686.32
5146410-14641088.40488.79
6147153-14715388.85389.29
45min1152741-15274192.22792.171.3792.8092.721.36
2154067-15406793.02793.58
3154291-15429193.16393.70
4148586-14858689.71890.26
5153147-15314792.47293.01
6153016-15301692.39392.97
60min1154206-15420693.11193.261.3493.8493.971.33
2155760-15576094.05094.76
3156426-15642694.45295.15
4150555-15055590.90791.60
5155073-15507393.63594.33
6154660-15466093.38594.12
极限1155839-15583994.09794.691.3294.9895.551.32
2158493-15849395.70096.57
3159056-15905696.04096.89
4153293-15329392.56093.40
5157217-15721794.92995.78
6157010-15701094.80495.69
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(%)99.7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%
111.924531534532624531354534904533374532750.04
211.984513524513354513440.01
单位质量响应值RSD%判断
38026.4337674.790.66数据可信
加速6月-供试品溶液-2024082721批-氢氯噻嗪坎
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1288392-28839254.69557.4211.3654.6957.4211.36
2299787-29978756.85656.86
3317022-31702260.12560.12
4289060-28906054.82254.82
5260390-26039049.38449.38
6361964-36196468.64868.65
10min1419091-41909179.48378.485.6979.5778.585.69
2428899-42889981.34381.44
3413491-41349178.42178.52
4397232-39723275.33775.43
5378678-37867871.81871.90
6445422-44542284.47684.59
15min1462646-46264687.74385.212.9487.9785.442.94
2457265-45726586.72386.95
3448391-44839185.04085.27
4439792-43979283.40983.63
5428431-42843181.25481.46
6459298-45929887.10887.36
20min1476736-47673690.41588.022.2490.7988.392.24
2472367-47236789.58789.96
3464662-46466288.12588.50
4459474-45947487.14287.50
5447136-44713684.80285.14
6464389-46438988.07488.47
30min1490261-49026192.98091.111.9693.5091.621.96
2489699-48969992.87493.40
3483237-48323791.64892.17
4480183-48018391.06991.57
5466964-46696488.56289.04
6472046-47204689.52690.07
45min1506189-50618996.00194.172.4896.6894.842.46
2508706-50870696.47997.16
3499538-49953894.74095.41
4500366-50036694.89795.55
5488688-48868892.68293.31
6475863-47586390.25090.95
60min1512738-51273897.24395.842.8698.0896.662.83
2517987-51798798.23999.08
3507368-50736896.22597.06
4512083-51208397.11997.93
5504297-50429795.64296.42
6477540-47754090.56891.41
极限1516600-51660097.97699.371.4098.97100.351.39
2524482-52448299.471100.47
3536746-536746101.797102.79
4525873-52587399.734100.71
5517516-51751698.14999.09
6522508-52250899.096100.09
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(%)99.8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%
116.461531781533381533661532581532971532870.05
216.421526351527461526900.06
单位质量响应值RSD%判断
9312.709299.030.11数据可信
加速6月-供试品溶液-2024082721批-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%
5min158699-5869935.41037.7510.4335.4137.7510.44
261509-6150937.10537.11
366234-6623439.95639.96
461362-6136237.01737.02
554375-5437532.80232.80
673284-7328444.20944.21
10min1103477-10347762.42264.434.7262.4864.504.73
2108482-10848265.44265.50
3108769-10876965.61565.68
4104666-10466663.14063.20
5100560-10056060.66360.72
6114903-11490369.31569.39
15min1127317-12731776.80476.421.7176.9776.591.72
2127706-12770677.03977.21
3126008-12600876.01476.19
4127381-12738176.84277.01
5122710-12271074.02574.18
6128945-12894577.78677.98
20min1138172-13817283.35282.321.4183.6482.621.41
2137925-13792583.20383.50
3135762-13576281.89882.20
4137984-13798483.23983.53
5133327-13332780.42980.71
6135634-13563481.82182.14
30min1148113-14811389.34987.751.7589.7888.181.74
2147579-14757989.02789.46
3144976-14497687.45787.90
4147082-14708288.72789.16
5143019-14301986.27686.69
6141996-14199685.65986.11
45min1151950-15195091.66490.812.0692.2491.392.05
2153151-15315192.38892.97
3150915-15091591.03991.62
4152952-15295292.26892.85
5149392-14939290.12190.68
6144884-14488487.40188.00
60min1153726-15372692.73592.082.0793.4792.812.05
2155177-15517793.61094.35
3153141-15314192.38293.12
4154930-15493093.46194.20
5152220-15222091.82792.53
6146621-14662188.44989.19
极限1156037-15603794.12994.731.3195.0295.621.31
2157425-15742594.96695.86
3160530-16053096.84097.73
4157892-15789295.24896.14
5155015-15501593.51394.37
6155331-15533193.70394.59
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