坎地氢噻片项目信息
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%
112.354719144717594717744717584716494717710.03
212.324701484702074701780.01
单位质量响应值RSD%判断
38200.0838163.800.07数据可信
供试品溶液-516246批-坎地沙坦酯-0.35tw20
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1391772-39177273.65571.507.0273.6671.507.02
2421447-42144779.23479.23
3380197-38019771.47971.48
4358393-35839367.38067.38
5345146-34514664.88964.89
6384780-38478072.34172.34
10min1512125-51212596.28293.613.4496.4093.723.44
2493495-49349592.78092.91
3501704-50170494.32394.44
4506171-50617195.16395.28
5465471-46547187.51187.62
6508358-50835895.57495.69
15min1514871-51487196.79896.581.6697.0896.851.67
2520295-52029597.81898.10
3518476-51847697.47697.75
4516103-51610397.03097.30
5496823-49682393.40593.66
6515584-51558496.93297.21
20min1513836-51383696.60496.941.0597.0597.381.06
2523652-52365298.44998.90
3518668-51866897.51297.95
4515123-51512396.84697.28
5507409-50740995.39695.81
6515080-51508096.83897.28
30min1512215-51221596.29996.771.0496.9097.371.05
2522557-52255798.24398.86
3518227-51822797.42998.03
4513852-51385296.60797.20
5506844-50684495.28995.86
6514766-51476696.77997.38
45min1511810-51181096.22396.601.0596.9997.361.06
2521427-52142798.03198.81
3517556-51755697.30398.07
4512249-51224996.30597.06
5505707-50570795.07695.80
6514279-51427996.68797.45
60min1509882-50988295.86096.351.0796.7997.271.07
2519767-51976797.71998.66
3517160-51716097.22998.15
4509749-50974995.83596.75
5504825-50482594.91095.80
6513441-51344196.53097.45
极限1508673-50867395.63396.281.0496.7297.361.05
2519613-51961397.69098.79
3516596-51659697.12398.21
4509891-50989195.86296.94
5505237-50523794.98796.03
6512684-51268496.38797.47
坎地氢噻片项目信息
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%
115.513056143056663057343058293058213057330.04
215.473061293057583059440.09
单位质量响应值RSD%判断
19711.9919776.600.24数据可信
供试品溶液-516246批-氢氯噻嗪-0.35tw20
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1142735-14273540.58340.986.7140.5840.986.71
2158179-15817944.97444.97
3150532-15053242.80042.80
4139025-13902539.52839.53
5129968-12996836.95336.95
6144279-14427941.02241.02
10min1274577-27457778.06976.433.6778.1476.503.67
2272066-27206677.35577.43
3269224-26922476.54776.62
4269670-26967076.67376.74
5249708-24970870.99871.06
6277548-27754878.91378.98
15min1321231-32123191.33390.372.5891.5390.572.59
2322623-32262391.72991.93
3319338-31933890.79590.99
4320350-32035091.08391.28
5301301-30130185.66785.85
6322288-32228891.63491.83
20min1335374-33537495.35595.081.4795.7095.421.48
2339103-33910396.41596.77
3335120-33512095.28295.63
4335483-33548395.38695.73
5324871-32487192.36892.69
6336469-33646995.66696.02
30min1339267-33926796.46296.860.9996.9797.371.00
2345537-34553798.24498.76
3341535-34153597.10697.62
4340818-34081896.90397.41
5335306-33530695.33595.81
6341649-34164997.13997.65
45min1338792-33879296.32696.610.9497.0097.280.95
2344508-34450897.95298.63
3340693-34069396.86797.54
4339710-33971096.58797.25
5334719-33471995.16895.80
6340361-34036196.77397.45
60min1337179-33717995.86896.270.9896.7097.100.99
2343903-34390397.78098.62
3339584-33958496.55297.38
4338127-33812796.13796.96
5333766-33376694.89795.69
6339076-33907696.40797.24
极限1336372-33637295.63895.930.9696.6396.920.97
2342536-34253697.39198.40
3337998-33799896.10197.09
4336720-33672095.73796.72
5332566-33256694.55695.51
6338148-33814896.14397.14
坎地氢噻片项目信息
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%
112.354703404701534700334701654698244701030.05
212.324689064671764680410.27
单位质量响应值RSD%判断
38065.0237990.340.14数据可信
供试品溶液-516246批-坎地沙坦酯-0.35tw20
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1189195-18919535.71434.5010.1435.7134.5010.14
2200129-20012937.77837.78
3155044-15504429.26729.27
4203779-20377938.46738.47
5177011-17701133.41433.41
6171439-17143932.36232.36
10min1340243-34024364.22767.516.7564.2967.576.74
2344715-34471565.07165.13
3328761-32876162.06062.11
4394411-39441174.45274.52
5368671-36867169.59369.65
6368951-36895169.64669.70
15min1410826-41082677.55180.214.3977.7280.384.39
2407353-40735376.89577.07
3406110-40611076.66176.81
4440322-44032283.11983.31
5446051-44605184.20084.37
6438691-43869182.81182.98
20min1448241-44824184.61486.743.5784.9187.053.58
2441280-44128083.30083.60
3446413-44641384.26884.55
4466215-46621588.00688.33
5480982-48098290.79491.11
6473960-47396089.46889.78
30min1485809-48580991.70592.522.5992.1492.972.60
2472105-47210589.11889.56
3481239-48123990.84291.26
4494729-49472993.38993.86
5504785-50478595.28795.75
6502241-50224194.80795.26
45min1513730-51373096.97695.671.8797.5796.271.87
2488908-48890892.29092.88
3505152-50515295.35795.93
4507574-50757495.81496.44
5510800-51080096.42397.04
6514624-51462497.14597.76
60min1515291-51529197.27096.241.6898.0297.001.68
2493993-49399393.25093.99
3508976-50897696.07896.81
4509047-50904796.09296.88
5513707-51370796.97197.75
6518090-51809097.79998.58
极限1517627-51762797.71197.281.2898.6298.201.28
2507847-50784795.86596.76
3511930-51193096.63697.53
4514005-51400597.02897.98
5513481-51348196.92997.87
6527032-52703299.487100.43
坎地氢噻片项目信息
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%
115.513065373064833064653064623058613063620.10
215.473054153059203056680.12
单位质量响应值RSD%判断
19752.5519758.760.03数据可信
供试品溶液-516246批-氢氯噻嗪-0.35tw20
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min165931-6593118.73518.7311.0318.7318.7311.03
274368-7436821.13221.13
355655-5565515.81515.81
473981-7398121.02221.02
563928-6392818.16618.17
661631-6163117.51317.51
10min1169405-16940548.13849.487.2948.1749.527.29
2170103-17010348.33648.37
3155361-15536144.14744.17
4193548-19354854.99855.03
5177039-17703950.30750.34
6179408-17940850.98051.01
15min1230938-23093865.62368.215.2265.7368.325.22
2233624-23362466.38666.50
3222919-22291963.34463.44
4253207-25320771.95172.08
5251161-25116171.37071.48
6248353-24835370.57270.69
20min1269187-26918776.49279.844.3376.7180.074.33
2272320-27232077.38277.61
3269409-26940976.55576.76
4287332-28733281.64881.89
5297108-29710884.42684.66
6290484-29048482.54482.78
30min1307983-30798387.51690.483.5687.8690.843.56
2308283-30828387.60187.96
3311407-31140788.48988.82
4319637-31963790.82891.21
5335651-33565195.37895.75
6327481-32748193.05793.43
45min1339646-33964696.51495.522.0897.0196.032.07
2323609-32360991.95692.46
3335579-33557995.35895.84
4334065-33406594.92895.46
5342607-34260797.35597.89
6341303-34130396.98497.51
60min1339884-33988496.58195.881.7897.2496.551.78
2326399-32639992.74993.40
3336923-33692395.74096.38
4336516-33651695.62496.32
5341666-34166697.08897.78
6343117-34311797.50098.19
极限1340527-34052796.76496.431.2597.5897.261.25
2333474-33347494.76095.57
3336893-33689395.73196.53
4338879-33887996.29697.15
5340256-34025696.68797.54
6346118-34611898.35399.20
坎地氢噻片项目信息
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%
112.354695174695074695344694264693794694730.02
212.324659434661854660640.04
单位质量响应值RSD%判断
38014.0137829.870.35数据可信
供试品溶液-516246批-坎地沙坦酯-0.35tw20
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1169587-16958732.10228.836.6332.1028.846.63
2142880-14288027.04727.05
3158516-15851630.00630.01
4149357-14935728.27328.27
5149450-14945028.29028.29
6144163-14416327.28927.29
10min1392440-39244074.28765.277.8874.3465.327.88
2349187-34918766.09966.14
3330666-33066662.59362.64
4310849-31084958.84258.89
5347312-34731265.74565.79
6338312-33831264.04164.09
15min1469403-46940388.85678.207.2289.0378.367.22
2403939-40393976.46476.62
3390075-39007573.83973.99
4388143-38814373.47473.62
5409205-40920577.46177.62
6417980-41798079.12279.27
20min1496664-49666494.01685.775.3694.3486.055.36
2435383-43538382.41682.70
3436784-43678482.68182.96
4438539-43853983.01383.28
5444556-44455684.15284.44
6466559-46655988.31788.60
30min1511285-51128596.78492.353.0397.2792.783.04
2474903-47490389.89790.32
3473276-47327689.58990.00
4484799-48479991.77092.18
5483623-48362391.54891.97
6499303-49930394.51694.95
45min1511923-51192396.90595.231.7297.5595.821.74
2492447-49244793.21893.79
3493805-49380593.47594.04
4501263-50126394.88795.45
5507154-50715496.00296.58
6511863-51186396.89397.48
60min1510574-51057496.64996.321.4997.4597.071.49
2499616-49961694.57595.30
3499943-49994394.63795.36
4510706-51070696.67497.39
5513993-51399397.29698.04
6518289-51828998.11098.86
极限1509619-50961996.46897.461.0597.4398.361.04
2510642-51064296.66297.54
3511505-51150596.82597.70
4517426-51742697.94698.82
5516338-51633897.74098.64
6523772-52377299.148100.06
坎地氢噻片项目信息
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%
115.513064073064833065653065193058483063640.10
215.473041113030113035610.26
单位质量响应值RSD%判断
19752.6819622.560.47数据可信
供试品溶液-516246批-氢氯噻嗪-0.35tw20
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min160228-6022817.17416.005.3517.1716.005.35
252635-5263515.00915.01
358533-5853316.69016.69
456449-5644916.09616.10
555883-5588315.93515.93
652960-5296015.10115.10
10min1184034-18403452.47647.516.4352.5047.546.42
2169083-16908348.21348.24
3156660-15666044.67144.70
4154828-15482844.14844.18
5170955-17095548.74748.77
6164093-16409346.79046.82
15min1259526-25952674.00266.676.1474.1266.776.14
2231940-23194066.13666.24
3219497-21949762.58862.69
4221393-22139363.12963.23
5235467-23546767.14267.25
6234990-23499067.00667.11
20min1302428-30242886.23679.095.2786.4879.315.27
2268774-26877476.63976.85
3260787-26078774.36274.57
4271710-27171077.47777.68
5275749-27574978.62878.85
6284737-28473781.19181.41
30min1334393-33439395.35090.813.8895.7391.163.88
2307055-30705587.55587.90
3303074-30307486.42086.75
4324077-32407792.40992.74
5314236-31423689.60389.95
6327978-32797893.52193.87
45min1339166-33916696.71195.512.2897.2596.022.28
2326251-32625193.02993.52
3324267-32426792.46392.94
4340562-34056297.10997.60
5338136-33813696.41896.92
6341436-34143697.35997.86
60min1338937-33893796.64696.201.7097.3596.861.70
2330765-33076594.31694.96
3329525-32952593.96294.59
4342235-34223597.58698.24
5341572-34157297.39798.06
6341178-34117897.28597.95
极限1337963-33796396.36896.780.7797.2397.600.77
2337721-33772196.29997.10
3335967-33596795.79996.58
4340532-34053297.10197.91
5342547-34254797.67598.50
6341761-34176197.45198.28
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