达格列净二甲双胍缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号101568-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)80.4对照品水分(%)0对照品稀释倍数1250
标示量(mg)10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%
112.651640201640931638571640461638921639820.07
212.621621791619471620630.11
单位质量响应值RSD%判断
12963.0012841.760.67数据可信
供试品溶液-WK2170批-达格列净-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1135574-13557467.58765.966.0267.5965.966.03
2140717-14071770.15170.15
3137622-13762268.60868.61
4129444-12944464.53164.53
5132275-13227565.94265.94
6118197-11819758.92458.92
10min1173824-17382486.65589.403.5886.7689.503.58
2180748-18074890.10790.21
3186509-18650992.97993.08
4176192-17619287.83687.93
5186802-18680293.12593.22
6171869-17186985.68185.77
15min1182196-18219690.82992.873.2591.0693.103.25
2184923-18492392.18892.43
3194862-19486297.14397.39
4182562-18256291.01191.24
5192788-19278896.10996.35
6180393-18039389.93090.15
20min1187517-18751793.48293.932.9093.8594.302.90
2185834-18583492.64393.02
3196182-19618297.80198.19
4185819-18581992.63593.00
5193598-19359896.51396.90
6181537-18153790.50090.85
30min1189443-18944394.44294.752.7394.9595.262.73
2186871-18687193.16093.68
3197474-19747498.44598.98
4187068-18706893.25893.76
5195216-19521697.32097.85
6184314-18431491.88592.37
45min1192285-19228595.85995.082.6496.5195.732.64
2186765-18676593.10793.76
3197638-19763898.52799.21
4187965-18796593.70594.35
5194866-19486697.14597.82
6184774-18477492.11492.74
60min1192290-19229095.86195.012.5096.6595.812.50
2187279-18727993.36394.16
3198019-19801998.71799.55
4187957-18795793.70194.49
5193019-19301996.22597.04
6184984-18498492.21992.98
120min1198959-19895999.18697.422.37100.1298.352.37
2191641-19164195.53896.47
3202766-202766101.084102.06
4193438-19343896.43397.36
5194852-19485297.13898.10
6190788-19078895.11296.01
180min1202228-202228100.81597.452.63101.9098.542.61
2190952-19095295.19496.27
3201798-201798100.601101.73
4192825-19282596.12897.20
5191840-19184095.63796.75
6193259-19325996.34497.39
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1196547-19654797.98396.552.9199.2297.782.90
2190602-19060295.02096.24
3203649-203649101.524102.80
4192906-19290696.16897.38
5188737-18873794.09095.34
6189627-18962794.53495.72
360min1197176-19717698.29795.883.2199.6897.253.18
2190451-19045194.94496.31
3201272-201272100.339101.77
4192239-19223995.83697.19
5183935-18393591.69693.09
6188853-18885394.14895.48
480min1194936-19493697.18095.203.2298.7196.723.19
2188882-18888294.16295.67
3200221-20022199.815101.40
4191190-19119095.31396.81
5182287-18228790.87492.41
6188231-18823193.83895.31
600min1195620-19562097.52194.553.4199.2096.223.38
2187836-18783693.64195.29
3198282-19828298.848100.58
4189434-18943494.43796.08
5180416-18041689.94291.61
6186426-18642692.93894.55
720min1193651-19365196.54093.883.4198.3695.683.37
2187032-18703293.24095.03
3196865-19686598.142100.02
4187903-18790393.67495.46
5178475-17847588.97490.78
6185955-18595592.70394.46
极限1193144-19314496.28793.503.2698.2695.453.23
2185889-18588992.67094.60
3195710-19571097.56699.59
4186976-18697693.21295.14
5178708-17870889.09091.03
6184887-18488792.17194.06
达格列净二甲双胍缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100664-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数10
标示量(mg)1000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%
19.358697378722288720638722148711918714870.13
29.378906608897898902240.07
单位质量响应值RSD%判断
93207.1795007.901.36数据可信
供试品溶液-WK2170批-二甲双胍-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min133391-333913.5483.624.573.553.624.53
235128-351283.7333.73
336732-367323.9043.90
432687-326873.4743.47
533125-331253.5203.52
633291-332913.5383.54
10min177968-779688.2868.515.658.298.515.65
287871-878719.3389.34
382177-821778.7338.74
478617-786178.3558.36
578892-788928.3848.39
674696-746967.9387.94
15min1114114-11411412.12712.472.3112.1412.492.32
2120503-12050312.80612.83
3120596-12059612.81612.83
4115147-11514712.23712.25
5117059-11705912.44012.46
6116587-11658712.39012.41
20min1158873-15887316.88415.884.0116.9215.924.00
2151822-15182216.13416.17
3151110-15111016.05916.10
4146135-14613515.53015.57
5147379-14737915.66215.70
6141273-14127315.01315.05
30min1199778-19977821.23121.052.2121.2921.122.21
2202644-20264421.53521.60
3201790-20179021.44421.51
4196096-19609620.83920.90
5197647-19764721.00421.06
6190744-19074420.27120.33
45min1255529-25552927.15527.432.1027.2527.522.09
2264757-26475728.13628.23
3263358-26335827.98728.08
4255963-25596327.20127.29
5258644-25864427.48627.58
6250212-25021226.59026.68
60min1305092-30509232.42232.741.8132.5632.871.81
2315936-31593633.57533.71
3312938-31293833.25633.39
4304887-30488732.40132.53
5308497-30849732.78432.92
6301064-30106431.99432.12
120min1468179-46817949.75449.871.2549.9450.051.26
2477511-47751150.74650.93
3474439-47443950.41950.61
4464422-46442249.35549.53
5468776-46877649.81750.00
6462100-46210049.10849.28
180min1595483-59548363.28361.921.4863.5462.181.48
2588153-58815362.50462.77
3584271-58427162.09162.35
4573252-57325260.92061.17
5581533-58153361.80062.06
6573543-57354360.95161.20
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1663082-66308270.46671.221.9370.8271.581.93
2674976-67497671.73072.09
3693294-69329473.67774.03
4660764-66076470.22070.57
5670609-67060971.26671.62
6658485-65848569.97870.32
360min1791649-79164984.12983.990.9984.5984.450.99
2800450-80045085.06585.53
3797531-79753184.75585.22
4784197-78419783.33883.79
5788283-78828383.77284.23
6780150-78015082.90783.35
480min1866955-86695592.13292.120.9092.7292.700.91
2872619-87261992.73493.33
3878566-87856693.36693.96
4860363-86036391.43292.01
5864715-86471591.89492.48
6857549-85754991.13391.70
600min1909186-90918696.62096.531.0097.3497.251.00
2912418-91241896.96497.70
3920053-92005397.77598.51
4899124-89912495.55196.26
5912931-91293197.01897.74
6896241-89624195.24595.95
720min1920494-92049497.82297.960.8998.6998.830.89
2927736-92773698.59299.47
3935077-93507799.372100.25
4914985-91498597.23798.09
5918655-91865597.62798.49
6913884-91388497.12097.97
极限1919833-91983397.75297.890.8998.7798.910.89
2927507-92750798.56799.59
3933907-93390799.247100.28
4913304-91330497.05898.06
5918886-91888697.65198.66
6913528-91352897.08298.08
达格列净二甲双胍缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号101568-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)80.4对照品水分(%)0对照品稀释倍数1250
标示量(mg)10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%
112.651674481672841672791671991672821672980.06
212.621663151662631662890.03
单位质量响应值RSD%判断
13225.1413176.620.26数据可信
供试品溶液-WK2170批-达格列净-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1153436-15343674.76068.275.4874.7668.275.48
2136863-13686366.68566.69
3144694-14469470.50170.50
4134258-13425865.41665.42
5133216-13321664.90864.91
6138244-13824467.35867.36
10min1186915-18691591.07385.714.2591.1885.814.24
2180818-18081888.10288.20
3175759-17575985.63785.74
4166533-16653381.14281.24
5169205-16920582.44482.54
6176262-17626285.88285.98
15min1192257-19225793.67689.103.3593.9289.333.35
2187427-18742791.32291.55
3180694-18069488.04288.28
4174808-17480885.17485.39
5181999-18199988.67888.90
6180054-18005487.73087.96
20min1192021-19202193.56189.923.1993.9590.283.19
2189675-18967592.41892.79
3182684-18268489.01189.38
4176264-17626485.88386.23
5186080-18608090.66691.02
6180526-18052687.96088.32
30min1194591-19459194.81390.973.1995.3491.473.18
2191578-19157893.34593.85
3183349-18334989.33589.84
4179933-17993387.67188.15
5189234-18923492.20392.69
6181504-18150488.43688.93
45min1193779-19377994.41791.243.4195.0991.883.40
2192942-19294294.00994.66
3182876-18287689.10589.74
4179045-17904587.23887.85
5192022-19202293.56194.19
6182929-18292989.13189.76
60min1193341-19334194.20491.583.3995.0292.363.38
2194016-19401694.53395.32
3182400-18240088.87389.64
4181107-18110788.24388.98
5193834-19383494.44495.21
6183072-18307289.20089.96
120min1198020-19802096.48493.753.9597.4494.663.93
2199620-19962097.26398.19
3187439-18743991.32892.23
4181732-18173288.54789.42
5199360-19936097.13798.05
6188276-18827691.73692.63
180min1195418-19541895.21693.113.9696.3294.163.95
2197715-19771596.33597.41
3186792-18679291.01392.05
4179984-17998487.69688.70
5199294-19929497.10498.16
6187325-18732591.27392.30
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1198284-19828496.61293.374.3697.8594.564.34
2197834-19783496.39397.61
3186416-18641690.83092.00
4179174-17917487.30188.44
5200045-20004597.47098.67
6188071-18807191.63692.80
360min1195006-19500695.01592.524.5396.4093.854.51
2197117-19711796.04497.41
3185626-18562690.44591.76
4176130-17613085.81887.08
5198533-19853396.73498.08
6186910-18691091.07092.38
480min1195587-19558795.29892.394.2096.8393.864.19
2195468-19546895.24096.75
3185300-18530090.28691.73
4177706-17770686.58687.98
5198032-19803296.48997.98
6185650-18565090.45691.90
600min1194443-19444394.74191.864.7696.4193.474.73
2196389-19638995.68997.34
3184604-18460489.94791.53
4174194-17419484.87586.40
5196829-19682995.90397.54
6184712-18471289.99991.58
720min1193499-19349994.28191.074.5696.1092.824.54
2193641-19364194.35096.15
3183497-18349789.40791.12
4172624-17262484.11085.76
5194053-19405394.55196.33
6184164-18416489.73291.45
极限1193440-19344094.25290.904.5896.2192.784.56
2192504-19250493.79695.73
3182775-18277589.05690.91
4172714-17271484.15385.93
5194607-19460794.82196.74
6183273-18327389.29891.15
达格列净二甲双胍缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100664-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数10
标示量(mg)1000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%
19.358832208827908825348827858823848827430.04
29.378889668870888880270.15
单位质量响应值RSD%判断
94411.0294773.430.28数据可信
供试品溶液-WK2170批-二甲双胍-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min137248-372483.9383.775.123.943.775.11
237961-379614.0134.01
335059-350593.7063.71
436202-362023.8273.83
533302-333023.5213.52
634053-340533.6003.60
10min186202-862029.1138.565.029.128.575.00
282851-828518.7598.76
382524-825248.7248.73
481777-817778.6458.65
574839-748397.9127.92
677681-776818.2128.22
15min1124808-12480813.19412.503.9313.2112.523.92
2119695-11969512.65412.67
3118731-11873112.55212.57
4120067-12006712.69312.71
5111533-11153311.79111.81
6114503-11450312.10512.12
20min1157262-15726216.62515.703.7716.6615.743.75
2149833-14983315.84015.88
3149368-14936815.79115.83
4149921-14992115.84915.89
5141436-14143614.95214.99
6143510-14351015.17115.21
30min1210172-21017222.21921.043.4822.2821.103.48
2201006-20100621.25021.31
3199644-19964421.10621.17
4200112-20011221.15521.22
5190837-19083720.17520.23
6192509-19250920.35220.41
45min1271355-27135528.68727.392.8328.7827.482.82
2261019-26101927.59427.69
3259610-25961027.44527.54
4259321-25932127.41527.51
5250882-25088226.52326.61
6252369-25236926.68026.77
60min1322077-32207734.04932.752.4234.1932.892.42
2312115-31211532.99633.13
3309067-30906732.67432.81
4311551-31155132.93633.07
5302438-30243831.97332.10
6301727-30172731.89832.03
120min1484691-48469151.24049.651.8151.4349.841.82
2472647-47264749.96750.15
3468465-46846549.52549.71
4468616-46861649.54149.72
5461553-46155348.79448.97
6462129-46212948.85549.03
180min1590945-59094562.47361.191.2962.7461.441.30
2581072-58107261.42961.69
3577655-57765561.06861.33
4579840-57984061.29961.56
5574778-57477860.76461.01
6568443-56844360.09460.34
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1686150-68615072.53870.561.4972.9070.911.49
2667715-66771570.58970.94
3663847-66384770.18070.53
4666275-66627570.43770.79
5663720-66372070.16770.51
6656809-65680969.43669.78
360min1800748-80074884.65383.480.9685.1283.930.97
2795683-79568384.11784.58
3788193-78819383.32683.78
4785463-78546383.03783.49
5788326-78832683.34083.78
6779376-77937682.39482.84
480min1882535-88253593.29991.741.0493.9092.321.04
2870943-87094392.07492.66
3865184-86518491.46592.04
4863850-86385091.32491.90
5868487-86848791.81492.38
6855551-85555190.44791.01
600min1919145-91914597.17096.260.9597.9196.980.95
2920628-92062897.32698.05
3907364-90736495.92496.64
4904869-90486995.66096.38
5912840-91284096.50397.21
6898450-89845094.98295.69
720min1931914-93191498.51997.500.8299.4098.370.83
2930569-93056998.37799.25
3922711-92271197.54798.41
4916948-91694896.93797.80
5918411-91841197.09297.94
6913350-91335096.55797.40
极限1932290-93229098.55997.510.7499.5998.520.74
2926676-92667697.96698.98
3921619-92161997.43198.44
4919769-91976997.23698.24
5921545-92154597.42398.42
6912187-91218796.43497.43
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