坎地沙坦酯氢氯噻嗪片项目信息
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%
112.224637864635334639254644954648304641140.12
212.204624264624844624550.01
单位质量响应值RSD%判断
37979.8737906.150.14数据可信
中间条件18月-供试品溶液-2024082821批-氢氯噻嗪-含0.35%吐温20的pH6.5磷酸盐溶液
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1356441-35644167.43567.286.4067.4367.286.41
2333416-33341663.07963.08
3381340-38134072.14572.15
4364960-36496069.04669.05
5373912-37391270.74070.74
6323824-32382461.26461.26
10min1467378-46737888.42383.823.8788.5483.933.87
2433346-43334681.98482.09
3455867-45586786.24586.37
4440140-44014083.27083.38
5443069-44306983.82483.94
6418472-41847279.17079.27
15min1480139-48013990.83787.402.5091.1087.652.51
2462612-46261287.52187.76
3465805-46580588.12588.39
4460631-46063187.14687.40
5458141-45814186.67586.93
6444525-44452584.09984.33
20min1483749-48374991.52088.782.0491.9389.182.04
2473452-47345289.57289.96
3470160-47016088.94989.36
4468046-46804688.54988.95
5465557-46555788.07888.48
6454745-45474586.03386.41
30min1489015-48901592.51690.671.6593.0891.221.65
2485972-48597291.94192.48
3474667-47466789.80290.36
4483532-48353291.47992.03
5472028-47202889.30389.85
6470331-47033188.98289.50
45min1491270-49127092.94392.081.8093.6692.781.79
2495538-49553893.75094.44
3479033-47903390.62891.34
4496483-49648393.92994.63
5476942-47694290.23290.93
6480945-48094590.99091.66
60min1491608-49160893.00792.522.0893.8893.372.06
2499620-49962094.52395.37
3478704-47870490.56691.43
4501362-50136294.85295.71
5478202-47820290.47191.32
6484588-48458891.67992.50
极限1510531-51053196.58797.000.9697.6198.010.96
2512392-51239296.93997.94
3516104-51610497.64198.65
4518943-51894398.17899.19
5513699-51369997.18698.19
6504736-50473695.49196.46
坎地沙坦酯氢氯噻嗪片项目信息
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%
116.453044993044963046083047423046983046090.04
216.383040473039343039900.03
单位质量响应值RSD%判断
18517.2618558.610.16数据可信
中间条件18月-供试品溶液-2024082821批-坎地沙坦酯-含0.35%吐温20的pH6.5磷酸盐溶液
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min199378-9937830.09430.217.6430.0930.217.65
294021-9402128.47228.47
3110316-11031633.40633.41
499909-9990930.25530.25
5105672-10567232.00032.00
689237-8923727.02327.02
10min1184582-18458255.89653.484.9355.9553.534.94
2167541-16754150.73650.78
3187270-18727056.71056.77
4174661-17466152.89252.94
5179380-17938054.32154.37
6166263-16626350.34950.39
15min1225446-22544668.27165.703.1168.4165.843.11
2210798-21079863.83563.97
3223861-22386167.79167.94
4215361-21536165.21765.36
5217487-21748765.86166.00
6208800-20880063.23063.36
20min1249723-24972375.62272.902.4475.8873.152.45
2236047-23604771.48171.72
3245268-24526874.27374.54
4237722-23772271.98872.24
5241152-24115273.02773.28
6234422-23442270.98971.22
30min1276032-27603283.58980.991.7983.9781.361.79
2265275-26527580.33280.69
3269024-26902481.46781.85
4267220-26722080.92181.29
5264758-26475880.17580.55
6262404-26240479.46379.82
45min1291405-29140588.24586.251.4088.7786.751.40
2285386-28538686.42286.91
3283877-28387785.96586.49
4286350-28635086.71487.22
5280068-28006884.81285.32
6281725-28172585.31385.80
60min1295109-29510989.36687.891.4090.0488.541.40
2291033-29103388.13288.77
3290593-29059387.99988.66
4293504-29350488.88089.53
5284213-28421386.06786.72
6286980-28698086.90587.53
极限1301601-30160191.33291.031.1092.1591.821.11
2298640-29864090.43691.22
3303746-30374691.98292.79
4304621-30462192.24793.04
5298855-29885590.50191.29
6296072-29607289.65890.43
坎地沙坦酯氢氯噻嗪片项目信息
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%
112.224631524629334631754631354630474630880.03
212.204625814625924625860.01
单位质量响应值RSD%判断
37895.9137916.890.04数据可信
中间条件18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%
5min1308615-30861558.44365.4713.8958.4465.4713.89
2309909-30990958.68858.69
3336143-33614363.65663.66
4325601-32560161.66061.66
5357769-35776967.75167.75
6436370-43637082.63682.64
10min1453629-45362985.90586.435.0986.0086.545.10
2428515-42851581.14981.25
3431972-43197281.80381.91
4466246-46624688.29488.40
5469145-46914588.84388.96
6488904-48890492.58592.72
15min1476206-47620690.18090.893.2290.4291.143.23
2469704-46970488.94989.18
3457976-45797686.72886.97
4495677-49567793.86794.12
5481828-48182891.24591.51
6498293-49829394.36394.65
20min1484798-48479891.80792.302.5392.2092.702.54
2485254-48525491.89392.27
3467564-46756488.54388.93
4502628-50262895.18495.59
5485826-48582692.00292.41
6498366-49836694.37694.83
30min1493384-49338493.43393.961.9493.9894.521.94
2501126-50112694.89995.43
3482561-48256191.38391.92
4508962-50896296.38396.95
5489190-48919092.63993.21
6501716-50171695.01195.62
45min1499058-49905894.50795.062.0895.2195.782.07
2514972-51497297.52198.21
3491078-49107892.99693.68
4513241-51324197.19397.92
5491041-49104192.98993.71
6502475-50247595.15595.92
60min1501456-50145694.96295.402.4195.8296.272.39
2521963-52196398.84599.70
3493733-49373393.49994.34
4513883-51388397.31598.20
5490032-49003292.79893.67
6501434-50143494.95795.88
极限1531514-531514100.65499.540.60101.67100.580.59
2525127-52512799.444100.46
3523592-52359299.154100.15
4526480-52648099.700100.75
5522885-52288599.020100.05
6524337-52433799.295100.38
坎地沙坦酯氢氯噻嗪片项目信息
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%
116.453037173041923040233040523042593040490.07
216.383043563044403043980.02
单位质量响应值RSD%判断
18483.2218583.520.39数据可信
中间条件18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%
5min189463-8946327.09929.1713.0527.1029.1713.05
290889-9088927.53027.53
393749-9374928.39728.40
486700-8670026.26226.26
595980-9598029.07329.07
6121088-12108836.67836.68
10min1177234-17723453.68454.865.9953.7354.905.99
2171005-17100551.79851.84
3173971-17397152.69652.74
4176478-17647853.45653.50
5188208-18820857.00957.06
6199727-19972760.49860.56
15min1227422-22742268.88769.143.5269.0269.283.53
2221487-22148767.08967.22
3219452-21945266.47266.61
4227794-22779468.99969.13
5231537-23153770.13370.28
6241941-24194173.28473.45
20min1256758-25675877.77277.322.4178.0277.572.42
2252013-25201376.33576.58
3245436-24543674.34374.59
4255912-25591277.51677.76
5257635-25763578.03878.30
6263803-26380379.90680.19
30min1284451-28445186.16185.551.7086.5485.941.71
2282586-28258685.59685.97
3274400-27440083.11683.49
4284860-28486086.28586.66
5280006-28000684.81485.20
6288331-28833187.33687.75
45min1292269-29226988.52989.431.5089.0589.961.49
2299734-29973490.79091.30
3289143-28914387.58288.09
4299176-29917690.62191.14
5292883-29288388.71589.25
6298342-29834290.36890.93
60min1298381-29838190.38090.711.3191.0591.391.30
2304819-30481992.33093.00
3295638-29563889.54990.20
4302199-30219991.53792.21
5294826-29482689.30389.98
6301048-30104891.18891.90
极限1312926-31292694.78693.450.8895.6194.280.88
2308917-30891793.57294.39
3306198-30619892.74893.55
4309038-30903893.60894.43
5305173-30517392.43793.27
6308925-30892593.57494.44
坎地沙坦酯氢氯噻嗪片项目信息
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%
112.224619694619684620144619134620494619830.02
212.204630634631164630900.01
单位质量响应值RSD%判断
37805.4837958.200.29数据可信
中间条件18月-供试品溶液-2024090121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%
5min1370405-37040570.19068.3512.7570.1968.3512.75
2293465-29346555.61055.61
3329635-32963562.46462.46
4350460-35046066.41166.41
5412562-41256278.17978.18
6407530-40753077.22577.23
10min1451357-45135785.53083.605.6985.6583.725.70
2393736-39373674.61174.70
3439760-43976083.33283.44
4442391-44239183.83183.94
5466427-46642788.38688.52
6453377-45337785.91386.04
15min1463144-46314487.76486.433.6488.0286.683.65
2427413-42741380.99381.21
3452608-45260885.76786.01
4453867-45386786.00686.26
5477197-47719790.42790.70
6462346-46234687.61287.88
20min1466409-46640988.38288.053.1788.7988.453.18
2444146-44414684.16484.52
3456497-45649786.50486.89
4458352-45835286.85687.25
5480913-48091391.13191.56
6481574-48157491.25691.67
30min1471885-47188589.42089.131.7689.9789.671.77
2465161-46516188.14688.64
3463203-46320387.77588.30
4465578-46557888.22588.76
5485723-48572392.04292.62
6470427-47042789.14489.71
45min1476307-47630790.25890.451.8490.9691.141.82
2486683-48668392.22492.86
3468293-46829388.73989.42
4470636-47063689.18389.87
5489403-48940392.74093.47
6472673-47267389.56990.29
60min1479424-47942490.84991.082.4991.7091.922.46
2500089-50008994.76495.56
3470047-47004789.07289.90
4471441-47144189.33690.17
5489682-48968292.79293.68
6473058-47305889.64290.51
极限1518754-51875498.30197.540.9699.3198.540.95
2515770-51577097.73698.69
3517126-51712697.99398.97
4508573-50857396.37297.36
5519540-51954098.45099.49
6508765-50876596.40997.43
坎地沙坦酯氢氯噻嗪片项目信息
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%
116.453039063039853038873039823037163038950.04
216.383049973053443051700.09
单位质量响应值RSD%判断
18473.8618630.650.60数据可信
中间条件18月-供试品溶液-2024090121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%
5min1110522-11052233.44432.0112.2433.4432.0112.24
285906-8590625.99525.99
395809-9580928.99128.99
4105605-10560531.95631.96
5118481-11848135.85235.85
6118389-11838935.82435.82
10min1195467-19546759.14857.557.5759.2057.607.58
2162249-16224949.09649.14
3190162-19016257.54257.59
4193106-19310658.43358.49
5203492-20349261.57661.64
6196651-19665159.50659.57
15min1236078-23607871.43670.125.4871.5970.275.49
2206571-20657162.50862.63
3235201-23520171.17171.32
4235523-23552371.26871.42
5242680-24268073.43473.60
6234243-23424370.88171.04
20min1257583-25758377.94477.534.3178.2277.794.32
2235034-23503471.12171.35
3256548-25654877.63177.89
4258156-25815678.11778.39
5264269-26426979.96780.25
6265646-26564680.38480.66
30min1277115-27711583.85483.422.2484.2683.822.25
2264175-26417579.93880.29
3278721-27872184.34084.73
4275894-27589483.48583.88
5282413-28241385.45785.88
6275850-27585083.47183.88
45min1287656-28765687.04486.681.1487.5987.221.15
2282604-28260485.51586.00
3287762-28776287.07687.61
4286266-28626686.62387.16
5291295-29129588.14588.71
6283117-28311785.67086.22
60min1291787-29178788.29487.681.1888.9888.361.17
2290782-29078287.99088.61
3289290-28929087.53888.22
4290745-29074587.97888.66
5292789-29278988.59789.30
6283231-28323185.70586.40
极限1302977-30297791.68091.130.9092.5291.960.89
2303689-30368991.89592.67
3301687-30168791.28992.11
4298364-29836490.28491.11
5303012-30301291.69092.55
6297255-29725589.94890.78
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