西格列汀二甲双胍片项目信息
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DSTP-202308101B对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.28对照品水分(%)0对照品稀释倍数200
标示量(mg)50供试品稀释倍数1系数0.8061
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.968214482205821208213882147821510.04
213.908218882180821840.01
单位质量响应值RSD%判断
5884.745912.520.34数据可信
供试品溶液-2024031621批-50mg/850mg规格-西格列汀-醋酸-醋酸钠缓冲液(pH4.5)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min113249-1324915.68915.4817.9215.6915.4817.90
212216-1221614.46614.47
316412-1641219.43519.43
49235-923510.93610.94
513456-1345615.93415.93
613884-1388416.44116.44
10min137335-3733544.21143.2913.3144.2443.3213.32
234204-3420440.50440.53
342779-4277950.65850.69
428366-2836633.59133.61
538591-3859145.69945.73
638061-3806145.07145.10
15min159395-5939570.33567.7810.4570.4367.8810.46
254568-5456864.61864.71
364623-6462376.52576.64
446941-4694155.58755.66
559513-5951370.47470.58
658389-5838969.14369.25
20min171485-7148584.65184.657.5184.8784.867.52
269048-6904881.76581.96
378708-7870893.20593.45
462685-6268574.23174.40
573882-7388287.49087.71
673080-7308086.54086.76
30min183581-8358198.97597.951.8199.3398.301.84
282810-8281098.06298.40
384765-84765100.377100.78
480330-8033095.12595.42
582794-8279498.04398.41
682023-8202397.13097.49
45min184697-84697100.29799.840.85100.82100.350.85
285031-85031100.692101.19
384669-84669100.264100.83
484276-8427699.798100.25
584168-8416899.670100.20
683003-8300398.29198.81
60min184787-84787100.40399.950.83101.09100.630.81
285234-85234100.933101.60
384345-8434599.880100.61
484638-84638100.227100.84
584268-8426899.789100.48
683171-8317198.49099.18
极限184711-84711100.313100.090.98101.17100.940.95
285505-85505101.254102.09
383988-8398899.457100.36
485304-85304101.016101.80
584298-8429899.824100.69
683320-8332098.66699.52
西格列汀二甲双胍片项目信息
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DA-1142209074对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数10
标示量(mg)850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%
19.563863866387168438756313892540388605838779560.30
29.553882322388376738830440.03
单位质量响应值RSD%判断
405643.93406601.470.17数据可信
供试品溶液-2024031621批-50mg/850mg规格-二甲双胍-醋酸-醋酸钠缓冲液(pH4.5)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1800444-80044420.84820.4515.3720.8520.4515.37
2750830-75083019.55619.56
3960939-96093925.02825.03
4586296-58629615.27015.27
5801323-80132320.87120.87
6811636-81163621.13921.14
10min11948856-194885650.75949.0611.4550.7949.0911.45
21798592-179859246.84546.88
32153107-215310756.07956.12
41508685-150868539.29439.32
51946452-194645250.69650.73
61945511-194551150.67250.71
15min12758163-275816371.83869.988.6471.9670.108.65
22574015-257401567.04167.15
32974452-297445277.47177.61
42291037-229103759.67159.76
52776629-277662972.31972.44
62747164-274716471.55171.67
20min13220020-322002083.86783.766.2984.1184.006.30
23096637-309663780.65380.88
33487922-348792290.84591.11
42895277-289527775.40975.60
53298011-329801185.89886.14
63297636-329763685.88986.13
30min13633426-363342694.63493.701.3995.0194.081.41
23583991-358399193.34793.70
33665958-366595895.48295.90
43519273-351927391.66191.98
53593918-359391893.60593.99
63589775-358977593.49793.88
45min13675476-367547695.73095.450.6396.2795.980.64
23671294-367129495.62196.13
33699458-369945896.35496.93
43663862-366386295.42795.90
53642085-364208594.86095.40
63636754-363675494.72195.26
60min13695799-369579996.25995.600.7396.9596.290.72
23679720-367972095.84096.51
33679813-367981395.84396.58
43691526-369152696.14896.78
53648595-364859595.02995.73
63627848-362784894.48995.18
极限13680471-368047195.86095.510.5396.7296.360.51
23681416-368141695.88496.72
33660253-366025395.33396.23
43688639-368863996.07296.86
53642438-364243894.86995.72
63648398-364839895.02495.88
西格列汀二甲双胍片项目信息
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DSTP-202308101B对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.28对照品水分(%)0对照品稀释倍数200
标示量(mg)50供试品稀释倍数1系数0.8061
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.968286882836829848296983208829730.18
213.908184781764818060.08
单位质量响应值RSD%判断
5943.625885.320.70数据可信
供试品溶液-2024031621批-50mg/850mg规格-西格列汀-0.025mol/L氯化钠溶液
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min116120-1612019.03814.4419.8919.0414.4419.89
210201-1020112.04812.05
313595-1359516.05616.06
411681-1168113.79613.80
512396-1239614.64014.64
69381-938111.07911.08
10min139897-3989747.12041.8510.3447.1541.8810.34
232631-3263138.53838.56
337636-3763644.44944.48
436847-3684743.51843.54
535859-3585942.35142.38
629758-2975835.14535.16
15min160752-6075271.75066.816.3571.8666.906.35
256360-5636066.56366.65
357364-5736467.74967.85
457350-5735067.73267.83
557664-5766468.10368.20
649906-4990658.94159.02
20min171714-7171484.69782.853.1084.9383.063.11
271341-7134184.25684.45
369398-6939881.96182.18
472410-7241085.51985.73
569627-6962782.23282.44
666431-6643178.45778.63
30min182580-8258097.53096.411.4397.9096.761.43
283102-8310298.14698.48
380293-8029394.82995.18
482194-8219497.07497.42
580444-8044495.00795.35
681192-8119295.89096.20
45min185746-85746101.26998.812.05101.8099.322.04
285910-85910101.463101.96
381926-8192696.75797.27
482783-8278397.76998.28
582834-8283497.83098.33
682801-8280197.79198.26
60min185650-85650101.15598.881.83101.8699.551.83
285512-85512100.992101.66
382083-8208396.94397.61
482480-8248097.41298.09
583551-8355198.67699.34
683059-8305998.09598.72
极限185828-85828101.36699.281.81102.24100.111.81
286076-86076101.659102.50
382760-8276097.74298.57
482626-8262697.58498.42
583674-8367498.82299.65
683397-8339798.49599.29
西格列汀二甲双胍片项目信息
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DA-1142209074对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数10
标示量(mg)850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%
19.563901581389147738989343893602389333338957850.11
29.553881211388535138832810.08
单位质量响应值RSD%判断
407508.89406626.280.16数据可信
供试品溶液-2024031621批-50mg/850mg规格-二甲双胍-0.025mol/L氯化钠溶液
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11006203-100620326.14620.8215.4926.1520.8215.50
2698351-69835118.14718.15
3863142-86314222.42922.43
4763236-76323619.83319.83
5813987-81398721.15121.15
6663352-66335217.23717.24
10min12123080-212308055.16850.318.3355.2150.358.34
21814524-181452447.15047.18
32047858-204785853.21453.25
41993371-199337151.79851.83
51955774-195577450.82150.86
61682997-168299743.73343.76
15min12997561-299756177.89273.715.2878.0373.835.29
22815893-281589373.17173.28
32882019-288201974.88975.02
42881379-288137974.87374.99
52887649-288764975.03675.16
62555370-255537066.40166.50
20min13418526-341852688.83087.632.3389.1087.872.34
23412925-341292588.68588.92
33346210-334621086.95187.20
43463090-346309089.98890.23
53353304-335330487.13687.38
63239161-323916184.17084.38
30min13812149-381214999.05998.610.9299.4799.000.91
23836683-383668399.696100.07
33748788-374878897.41297.81
43810917-381091799.02799.42
53755569-375556997.58997.98
63805116-380511698.87699.23
45min13918530-3918530101.823100.361.24102.40100.921.24
23921917-3921917101.911102.46
33807026-380702698.92699.48
43825861-382586199.41599.97
53847543-384754399.978100.53
63853410-3853410100.131100.65
60min13917641-3917641101.800100.441.21102.55101.161.20
23926876-3926876102.040102.75
33817280-381728099.19299.92
43824286-382428699.374100.10
53848723-3848723100.009100.73
63857689-3857689100.242100.93
极限13911584-3911584101.643100.491.19102.56101.381.19
23930810-3930810102.142103.03
33824106-382410699.369100.26
43816699-381669999.177100.07
53859213-3859213100.282101.17
63860816-3860816100.323101.17
西格列汀二甲双胍片项目信息
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DSTP-202308101B对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.28对照品水分(%)0对照品稀释倍数200
标示量(mg)50供试品稀释倍数1系数0.8061
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.968182081700818158185881844818070.08
213.908173381770817520.04
单位质量响应值RSD%判断
5860.105881.440.26数据可信
供试品溶液-2024031621批-50mg/850mg规格-西格列汀-pH1.2盐酸溶液
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min114512-1451217.26616.3310.6217.2716.3310.64
214995-1499517.84117.84
315320-1532018.22818.23
412139-1213914.44314.44
511922-1192214.18514.18
613458-1345816.01216.01
10min139475-3947546.96746.2910.6147.0046.3210.61
244231-4423152.62652.66
343396-4339651.63351.66
435852-3585242.65742.68
535532-3553242.27642.30
634955-3495541.58941.62
15min160059-6005971.45870.716.8571.5770.826.85
262571-6257174.44774.56
365363-6536377.76977.89
457466-5746668.37368.47
556857-5685767.64867.74
654263-5426364.56264.66
20min173499-7349987.44987.885.4587.6888.105.46
275485-7548589.81290.05
380505-8050595.78596.03
473169-7316987.05687.27
572167-7216785.86486.07
668317-6831781.28481.49
30min181881-8188197.42298.372.7797.7998.742.78
282858-8285898.58498.98
386308-86308102.689103.09
484141-84141100.111100.47
580753-8075396.08096.43
680138-8013895.34895.69
45min182886-8288698.61899.592.1499.15100.122.16
283937-8393799.868100.42
386330-86330102.715103.29
485180-85180101.347101.87
581898-8189897.44297.95
681981-8198197.54198.04
60min182691-8269198.38699.741.9599.08100.441.97
284434-84434100.460101.18
386003-86003102.326103.07
485293-85293101.482102.17
582111-8211197.69698.37
682458-8245898.10998.77
极限183018-8301898.775100.331.5799.64101.191.58
284839-84839100.941101.83
385656-85656101.913102.83
485874-85874102.173103.03
583716-8371699.605100.44
682826-8282698.54699.37
西格列汀二甲双胍片项目信息
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DA-1142209074对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数10
标示量(mg)850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%
19.563886080388748238854093886498388491938860780.03
29.553884601388145038830260.06
单位质量响应值RSD%判断
406493.51406599.580.02数据可信
供试品溶液-2024031621批-50mg/850mg规格-二甲双胍-pH1.2盐酸溶液
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1892717-89271723.22722.069.9123.2322.069.92
2910957-91095723.70223.70
3943024-94302424.53624.54
4749803-74980319.50919.51
5744986-74498619.38319.38
6845077-84507721.98721.99
10min12108349-210834954.85653.898.7054.8953.928.70
22305392-230539259.98260.02
32259266-225926658.78258.82
41912231-191223149.75349.79
51923654-192365450.05050.08
61918113-191811349.90649.94
15min13007134-300713478.24077.255.3278.3777.385.33
23101195-310119580.68880.83
33193887-319388783.09983.24
42849224-284922474.13274.25
52871674-287167474.71674.83
62792165-279216572.64772.77
20min13565147-356514792.75992.683.7693.0292.943.77
23611319-361131993.96094.23
33790925-379092598.63398.91
43494185-349418590.91391.15
53517888-351788891.52991.77
63394338-339433888.31588.56
30min13901705-3901705101.516101.631.53101.93102.041.54
23900019-3900019101.472101.90
34011412-4011412104.370104.81
43922723-3922723102.063102.45
53844130-3844130100.018100.41
63857360-3857360100.362100.75
45min13941367-3941367102.548102.820.81103.13103.400.82
23943471-3943471102.602103.20
34007699-4007699104.273104.89
43967365-3967365103.224103.78
53918249-3918249101.946102.51
63931848-3931848102.300102.86
60min13933413-3933413102.341102.900.65103.10103.660.66
23945572-3945572102.657103.43
33998288-3998288104.029104.82
43972348-3972348103.354104.09
53934440-3934440102.367103.10
63945827-3945827102.664103.39
极限13936447-3936447102.420103.050.47103.35103.980.47
23957785-3957785102.975103.92
33984240-3984240103.663104.63
43980535-3980535103.567104.47
53954753-3954753102.896103.80
63950808-3950808102.793103.69
西格列汀二甲双胍片项目信息
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DSTP-202308101B对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.28对照品水分(%)0对照品稀释倍数200
标示量(mg)50供试品稀释倍数1系数0.8061
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.968114281255812528115981045811710.11
213.908159981720816600.11
单位质量响应值RSD%判断
5814.545874.820.73数据可信
供试品溶液-2024031621批-50mg/850mg规格-西格列汀-磷酸盐缓冲液(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%
5min111036-1103613.19012.9618.7413.1912.9618.74
211092-1109213.25613.26
39460-946011.30611.31
49079-907910.85110.85
514635-1463517.49117.49
69776-977611.68411.68
10min132708-3270839.09138.429.6039.1138.449.60
232954-3295439.38539.41
329884-2988435.71635.73
428431-2843133.97934.00
537372-3737244.66544.69
631550-3155037.70737.73
15min153367-5336763.78161.844.1963.8761.924.20
252599-5259962.86362.95
349923-4992359.66559.74
448244-4824457.65857.73
553646-5364664.11464.22
652669-5266962.94763.03
20min168175-6817581.47979.183.0281.6779.373.02
267065-6706580.15280.34
363809-6380976.26176.44
463711-6371176.14376.31
566839-6683979.88280.09
667915-6791581.16881.36
30min182778-8277898.93196.383.3199.2696.703.31
278695-7869594.05194.38
378566-7856693.89794.20
478026-7802693.25293.55
581155-8115596.99197.34
684618-84618101.130101.45
45min184245-84245100.68498.621.18101.1899.101.19
281269-8126997.12897.61
382553-8255398.66299.12
482155-8215598.18798.64
582281-8228198.33798.84
682621-8262198.74499.23
60min184464-84464100.94699.081.09101.6199.721.09
281826-8182697.79398.44
383093-8309399.30899.93
483106-8310699.32399.94
582395-8239598.47399.14
682526-8252698.63099.29
极限185086-85086101.690100.061.36102.52100.881.34
283311-8331199.568100.38
384383-84383100.849101.64
484621-84621101.134101.92
582416-8241698.49999.33
682535-8253598.64199.46
西格列汀二甲双胍片项目信息
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DA-1142209074对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数10
标示量(mg)850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%
19.563869667386721738735993870089387089538702930.06
29.553871653387336438725080.04
单位质量响应值RSD%判断
404842.36405498.220.12数据可信
供试品溶液-2024031621批-50mg/850mg规格-二甲双胍-磷酸盐缓冲液(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%
5min1781236-78123620.39519.7514.3620.4019.7514.37
2767746-76774620.04320.04
3687571-68757117.95017.95
4657731-65773117.17117.17
5954848-95484824.92824.93
6690192-69019218.01918.02
10min11892630-189263049.41048.357.8949.4448.387.90
21890089-189008949.34449.38
31754872-175487245.81445.84
41674508-167450843.71643.74
52097053-209705354.74754.79
61802513-180251347.05847.09
15min12780869-278086972.59970.633.5972.7270.753.59
22739611-273961171.52271.64
32639858-263985868.91869.02
42544787-254478766.43666.54
52803556-280355673.19273.32
62724984-272498471.14071.25
20min13359251-335925187.69985.642.6087.9485.872.61
23309380-330938086.39786.63
33189944-318994483.27983.50
43157308-315730882.42782.64
53320378-332037886.68486.94
63346488-334648887.36687.59
30min13847803-3847803100.45398.462.05100.8498.832.05
23711661-371166196.89997.28
33721509-372150997.15697.52
43674912-367491295.94096.29
53827425-382742599.921100.32
63845015-3845015100.381100.75
45min13880752-3880752101.314100.160.77101.86100.700.77
23799019-379901999.18099.72
33845917-3845917100.404100.93
43810324-381032499.47599.98
53847833-3847833100.454101.02
63835274-3835274100.126100.67
60min13884255-3884255101.405100.360.66102.12101.070.66
23814228-381422899.577100.28
33858708-3858708100.738101.43
43837989-3837989100.197100.87
53848048-3848048100.460101.19
63823143-382314399.810100.52
极限13882835-3882835101.368100.500.65102.26101.380.65
23832212-3832212100.046100.92
33873408-3873408101.122101.98
43853255-3853255100.596101.44
53838506-3838506100.211101.11
63817860-381786099.672100.54
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