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%
112.608119281239813098132681325812780.08
212.618196581754818600.19
单位质量响应值RSD%判断
6450.636491.670.45数据可信
供试品溶液-WM0006批-达格列净-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%
5min134041-3404133.83539.3216.3133.8439.3216.31
238389-3838938.15738.16
344231-4423143.96443.96
442182-4218241.92741.93
547835-4783547.54647.55
630666-3066630.48130.48
10min180145-8014579.66182.565.2479.7182.625.24
282466-8246681.96882.03
380916-8091680.42780.49
489499-8949988.95889.02
587089-8708986.56386.63
678241-7824177.76877.81
15min195609-9560995.03194.452.8795.2094.632.87
292754-9275492.19492.37
390961-9096190.41290.60
497792-9779297.20197.40
595265-9526594.69094.89
697749-9774997.15997.32
20min196366-9636695.78495.842.5396.1096.162.52
294113-9411393.54593.86
393250-9325092.68793.01
497899-9789997.30897.65
597035-9703596.44996.79
699840-9984099.23799.55
30min198785-9878598.18897.632.8898.6498.102.87
296393-9639395.81196.27
394816-9481694.24394.70
498933-9893398.33598.82
597360-9736096.77297.26
6103057-103057102.434102.89
45min199466-9946698.86598.172.7299.4798.792.71
296616-9661696.03296.63
395388-9538894.81295.41
4101104-101104100.493101.13
597699-9769997.10997.74
6102346-102346101.728102.34
60min199463-9946398.86297.812.6399.6198.572.61
297063-9706396.47797.22
394984-9498494.41095.16
498967-9896798.36999.16
597383-9738396.79597.57
6102562-102562101.942102.71
120min1106234-106234105.592104.332.50106.49105.242.48
2103366-103366102.742103.63
3101150-101150100.539101.43
4105208-105208104.572105.51
5104939-104939104.305105.23
6108891-108891108.233109.15
180min1106272-106272105.630104.053.02106.69105.123.00
2103425-103425102.800103.85
3100434-10043499.827100.86
4105018-105018104.384105.47
5103219-103219102.595103.68
6109722-109722109.059110.14
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1106052-106052105.411103.982.93106.63105.202.92
2103007-103007102.385103.58
3100246-10024699.640100.83
4107048-107048106.401107.65
5102932-102932102.310103.54
6108416-108416107.761109.00
360min1104914-104914104.280102.702.78105.66104.072.77
2102103-102103101.486102.84
399474-9947498.873100.21
4103911-103911103.283104.69
5101768-101768101.153102.54
6107747-107747107.096108.50
480min1104268-104268103.638102.022.75105.17103.552.73
2101294-101294100.682102.19
399058-9905898.46099.94
4102686-102686102.066103.63
5101357-101357100.745102.28
6107191-107191106.544108.11
600min1103657-103657103.031101.102.87104.72102.782.86
2100530-10053099.923101.58
397812-9781297.22198.85
4101612-101612100.998102.71
5100427-10042799.820101.51
6106245-106245105.603107.33
720min1102726-102726102.105100.352.92103.95102.192.90
299603-9960399.001100.81
396956-9695696.37098.15
4100976-100976100.366102.23
599955-9995599.351101.19
6105568-105568104.930106.81
960min1101596-101596100.98299.042.98102.98101.032.96
298322-9832297.72899.68
395833-9583395.25497.18
499354-9935498.754100.77
598410-9841097.81699.80
6104360-104360103.730105.77
1440min199810-9981099.20797.443.00101.3599.572.97
296368-9636895.78697.89
394207-9420793.63895.70
498122-9812297.52999.69
597035-9703596.44998.58
6102658-102658102.038104.23
极限199962-9996299.35897.133.12101.6599.413.10
297194-9719496.60798.85
393009-9300992.44794.65
497394-9739496.80699.12
596805-9680596.22098.50
6101956-101956101.340103.69
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%
110.039773299763269778239762009761729767700.08
210.109782349787229784780.04
单位质量响应值RSD%判断
97384.8596879.010.37数据可信
供试品溶液-WM0006批-二甲双胍-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%
5min130549-305493.1453.1410.833.153.1410.83
236242-362423.7313.73
328910-289102.9762.98
426153-261532.6932.69
530896-308963.1813.18
630308-303083.1203.12
10min169490-694907.1547.578.747.167.578.76
280079-800798.2448.25
369389-693897.1447.15
466215-662156.8176.82
573508-735087.5687.57
682275-822758.4708.48
15min1106309-10630910.94511.402.4510.9611.412.45
2111930-11193011.52411.54
3109429-10942911.26611.28
4111086-11108611.43711.45
5110902-11090211.41811.43
6114430-11443011.78111.80
20min1135838-13583813.98514.282.8814.0214.322.86
2138333-13833314.24214.28
3141803-14180314.59914.63
4136665-13666514.07014.10
5145106-14510614.93914.97
6134629-13462913.86113.90
30min1188848-18884819.44319.871.9019.5019.931.89
2191016-19101619.66619.72
3195315-19531520.10820.16
4189643-18964319.52419.58
5195940-19594020.17320.23
6197506-19750620.33420.39
45min1251936-25193625.93826.845.9726.0226.935.95
2251940-25194025.93826.02
3259686-25968626.73626.82
4291434-29143430.00430.09
5259088-25908826.67426.76
6250354-25035425.77525.86
60min1304017-30401731.30031.511.3431.4231.631.33
2304121-30412131.31031.44
3311797-31179732.10132.22
4302773-30277331.17231.30
5310635-31063531.98132.11
6302831-30283131.17731.30
120min1484296-48429649.86050.341.2750.0350.511.26
2482970-48297049.72349.90
3493988-49398850.85851.03
4494163-49416350.87651.05
5495377-49537751.00151.17
6482732-48273249.69949.87
180min1602758-60275862.05662.450.7462.3062.690.74
2601566-60156661.93362.18
3611279-61127962.93363.18
4606672-60667262.45962.71
5612429-61242963.05263.30
6604602-60460262.24662.49
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1693507-69350771.39971.891.1771.7372.241.17
2689228-68922870.95871.30
3707626-70762672.85373.20
4708146-70814672.90673.25
5699385-69938572.00472.35
6691934-69193471.23771.58
360min1815884-81588483.99884.380.6584.4484.830.65
2812061-81206183.60484.05
3825987-82598785.03885.49
4821471-82147184.57385.03
5824276-82427684.86285.32
6818108-81810884.22784.67
480min1894085-89408592.04992.300.6892.6292.870.68
2887549-88754991.37691.95
3905550-90555093.23093.81
4897535-89753592.40492.98
5899534-89953492.61093.19
6894735-89473592.11692.69
600min1936915-93691596.45996.630.4597.1797.340.45
2931316-93131695.88296.59
3943630-94363097.15097.87
4939037-93903796.67797.40
5940113-94011396.78897.51
6940219-94021996.79997.51
720min1953944-95394498.21298.600.5799.0699.460.57
2949069-94906997.71098.56
3962325-96232599.07599.94
4957487-95748798.57799.44
5961313-96131398.97099.83
6962343-96234399.07799.93
960min1961534-96153498.99399.370.5399.99100.370.53
2958400-95840098.67199.67
3972035-972035100.074101.09
4962771-96277199.121100.13
5967216-96721699.578100.59
6968936-96893699.755100.76
1440min1958146-95814698.64498.990.6799.79100.150.67
2950331-95033197.84098.99
3966970-96697099.553100.72
4961977-96197799.039100.20
5965431-96543199.394100.56
6966395-96639599.494100.65
极限1961138-96113898.95298.530.50100.2599.830.50
2949344-94934497.73899.03
3953772-95377298.19499.51
4957174-95717498.54499.85
5962078-96207899.049100.36
6958517-95851798.68399.99
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%
112.608164081580815598151381313815210.16
212.618279282786827890.01
单位质量响应值RSD%判断
6469.926565.341.04数据可信
供试品溶液-WM0006批-达格列净-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%
5min139451-3945138.93541.9814.8138.9341.9714.82
252809-5280952.11852.12
344815-4481544.22944.23
433736-3373633.29533.29
541738-4173841.19241.19
642639-4263942.08142.08
10min185670-8567084.54986.244.7284.6186.304.72
289449-8944988.27888.36
385345-8534584.22884.29
486153-8615385.02685.08
583009-8300981.92381.98
694657-9465793.41893.48
15min195730-9573094.47794.243.7194.6694.433.70
292360-9236091.15191.36
391300-9130090.10590.30
495822-9582294.56894.75
596361-9636195.10095.28
6101344-101344100.018100.22
20min197332-9733296.05895.744.0496.3996.074.03
292867-9286791.65292.00
392364-9236491.15591.48
497009-9700995.74096.06
5100230-10023098.91899.25
6102247-102247100.909101.26
30min198239-9823996.95396.204.1097.4296.684.09
292669-9266991.45691.94
392770-9277091.55692.02
498326-9832697.03997.50
5100524-10052499.20999.68
6102355-102355101.016101.52
45min199219-9921997.92196.704.0198.5497.324.00
293337-9333792.11692.74
393226-9322692.00692.61
498380-9838097.09397.70
5101142-10114299.818100.44
6102594-102594101.251101.91
60min199185-9918597.88796.654.1198.6597.424.10
292501-9250191.29192.05
393386-9338692.16492.90
499501-9950198.19998.95
5100756-10075699.438100.21
6102260-102260100.922101.73
120min199759-9975998.45497.573.7399.3698.483.72
293197-9319791.97792.87
396116-9611694.85895.74
499091-9909197.79498.70
5101962-101962100.628101.55
6103077-103077101.728102.69
180min1105108-105108103.733102.384.13104.79103.444.11
298050-9805096.76797.80
399221-9922197.92398.94
4104145-104145102.782103.83
5107253-107253105.850106.92
6108661-108661107.239108.35
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1104562-104562103.194101.734.18104.41102.944.17
297364-9736496.09097.27
398243-9824396.95798.12
4103957-103957102.597103.80
5106821-106821105.423106.66
6107521-107521106.114107.39
360min1104120-104120102.758101.154.48104.13102.524.46
296370-9637095.10996.43
397831-9783196.55197.86
4102457-102457101.116102.47
5106452-106452105.059106.45
6107746-107746106.336107.77
480min1103581-103581102.226100.444.16103.75101.964.14
295892-9589294.63796.10
397398-9739896.12397.58
4102304-102304100.965102.47
5105223-105223103.846105.39
6106249-106249104.859106.45
600min1103176-103176101.82699.804.22103.50101.474.20
294840-9484093.59995.21
396881-9688195.61397.22
4102149-102149100.812102.47
5104392-104392103.026104.73
6105322-105322103.944105.69
720min1102589-102589101.24799.054.27103.08100.864.25
294281-9428193.04794.80
396029-9602994.77296.52
4100812-10081299.493101.30
5103578-103578102.223104.08
6104862-104862103.490105.39
960min1100837-10083799.51797.614.09101.5099.584.08
292919-9291991.70393.59
394961-9496193.71895.61
499730-9973098.425100.38
5102312-102312100.973102.99
6102696-102696101.352103.41
1440min190629-9062989.44393.964.5791.5796.064.53
290573-9057389.38891.41
393155-9315591.93693.96
497533-9753396.25798.36
598539-9853997.25099.41
6100783-10078399.464101.68
极限199143-9914397.84695.714.41100.1197.964.39
290543-9054389.35891.52
393129-9312991.91094.08
497296-9729696.02398.27
5100918-10091899.597101.91
6100821-10082199.502101.86
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%
110.039771069765029755589752319754649759720.09
210.109877409862599870000.11
单位质量响应值RSD%判断
97305.2897722.770.31数据可信
供试品溶液-WM0006批-二甲双胍-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%
5min140195-401954.1223.4521.164.123.4521.15
244475-444754.5614.56
326246-262462.6922.69
429211-292112.9963.00
529682-296823.0443.04
631977-319773.2793.28
10min170713-707137.2527.235.147.267.235.14
275924-759247.7867.79
367969-679696.9706.97
465943-659436.7626.77
569178-691787.0947.10
673170-731707.5047.51
15min1104783-10478310.74511.274.0610.7611.294.06
2110281-11028111.30911.33
3106755-10675510.94810.96
4107578-10757811.03211.05
5116655-11665511.96311.98
6113394-11339411.62911.64
20min1136236-13623613.97114.563.6814.0014.593.68
2148207-14820715.19915.23
3137973-13797314.14914.18
4137790-13779014.13014.16
5145529-14552914.92414.96
6146213-14621314.99415.03
30min1188242-18824219.30419.681.9719.3619.741.97
2194525-19452519.94920.01
3189630-18963019.44719.50
4190689-19068919.55519.61
5189981-18998119.48319.54
6198273-19827320.33320.39
45min1252038-25203825.84626.131.7225.9326.211.73
2259363-25936326.59826.69
3250713-25071325.71125.79
4252751-25275125.92026.00
5252544-25254425.89825.98
6261189-26118926.78526.87
60min1304282-30428231.20431.501.4031.3331.621.40
2308839-30883931.67131.80
3303036-30303631.07631.20
4310350-31035031.82631.95
5303181-30318131.09131.21
6313258-31325832.12532.25
120min1460505-46050547.22547.611.4347.3947.781.43
2467719-46771947.96448.14
3470983-47098348.29948.47
4456142-45614246.77746.95
5458787-45878747.04947.22
6471514-47151448.35448.53
180min1602437-60243761.78061.831.1662.0262.071.17
2607421-60742162.29162.54
3599913-59991361.52161.76
4593570-59357060.87061.11
5600233-60023361.55461.79
6613860-61386062.95163.20
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1691910-69191070.95571.131.0771.2971.471.07
2695062-69506271.27871.62
3687557-68755770.50970.84
4684155-68415570.16070.49
5698594-69859471.64171.97
6704522-70452272.24972.59
360min1818659-81865983.95383.801.1284.3984.241.12
2818407-81840783.92784.38
3814188-81418883.49583.93
4807003-80700382.75883.19
5811266-81126683.19583.64
6833370-83337085.46285.91
480min1899539-89953992.24891.670.7492.8192.240.74
2893997-89399791.67992.25
3894167-89416791.69792.26
4885150-88515090.77291.33
5888233-88823391.08891.65
6902596-90259692.56193.14
600min1939947-93994796.39195.860.6997.0996.560.70
2932201-93220195.59796.31
3933631-93363195.74496.44
4930257-93025795.39896.09
5927693-92769395.13595.84
6944898-94489896.89997.62
720min1960925-96092598.54397.760.7699.3998.610.77
2951447-95144797.57198.43
3952641-95264197.69398.54
4944273-94427396.83597.67
5947829-94782997.20098.04
6962734-96273498.72899.59
960min1969298-96929899.40198.560.66100.4099.560.66
2959322-95932298.37899.38
3961307-96130798.58299.57
4955290-95529097.96598.95
5954016-95401697.83498.82
6967589-96758999.226100.24
1440min1950011-95001197.42397.730.7698.5798.870.76
2947704-94770497.18798.34
3954024-95402497.83598.97
4946601-94660197.07498.20
5953085-95308597.73998.88
6966421-96642199.106100.27
极限1959462-95946298.39397.900.8999.6899.190.89
2948212-94821297.23998.53
3952713-95271397.70198.99
4945264-94526496.93798.21
5953760-95376097.80899.09
6968709-96870999.341100.65
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