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%
113.908030680328803568034080307803270.03
213.898012780119801230.01
单位质量响应值RSD%判断
5778.925768.390.13数据可信
影响因素30天-供试品溶液-2024050521批-西格列汀-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%
5min114327-1432717.33316.9212.5517.3316.9212.55
213443-1344316.26316.26
311018-1101813.33013.33
414624-1462417.69217.69
514138-1413817.10417.10
616385-1638519.82319.82
10min135969-3596943.51643.867.3543.5443.897.36
235152-3515242.52742.55
333809-3380940.90240.92
436956-3695644.71044.74
534461-3446141.69141.72
641199-4119949.84349.88
15min153425-5342564.63464.613.6064.7464.723.60
253624-5362464.87564.97
351903-5190362.79362.88
455359-5535966.97467.08
550616-5061661.23661.33
655526-5552667.17667.29
20min164181-6418177.64777.673.4077.8677.883.39
264854-6485478.46178.67
364608-6460878.16378.36
467405-6740581.54781.76
560689-6068973.42273.62
663484-6348476.80477.03
30min172565-7256587.79087.623.9388.1387.963.92
272560-7256087.78488.12
371339-7133986.30786.63
477799-7779994.12294.47
570242-7024284.97985.30
670056-7005684.75485.11
45min175316-7531691.11891.582.2191.6092.062.21
275458-7545891.29091.77
376057-7605792.01492.48
478790-7879095.32195.83
574185-7418589.75090.21
674364-7436489.96690.46
60min176442-7644292.48092.931.5493.1293.561.53
276828-7682892.94793.58
377371-7737193.60494.23
478711-7871195.22595.89
576319-7631992.33192.95
675195-7519590.97291.62
极限178091-7809194.47594.351.3995.2795.141.38
278176-7817694.57895.37
378343-7834394.78095.56
478642-7864295.14295.97
578814-7881495.35096.12
675857-7585791.77292.57
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20
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%
119.534267298427019042706474272373427223142705480.05
219.554260645425236842565060.14
单位质量响应值RSD%判断
218666.05217724.090.31数据可信
影响因素30天-供试品溶液-2024050521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%
5min11009408-100940824.46724.0410.8924.4724.0410.89
2953315-95331523.10723.11
3811550-81155019.67119.67
41028658-102865824.93424.93
51007002-100700224.40924.41
61141512-114151227.66927.67
10min12227408-222740853.99054.505.6254.0354.545.62
22204139-220413953.42653.46
32134060-213406051.72851.76
42281996-228199655.31355.36
52159948-215994852.35552.40
62483397-248339760.19560.24
15min13097896-309789675.09075.322.6075.2275.452.60
23122796-312279675.69475.82
33054073-305407374.02874.15
43190952-319095277.34677.48
52985371-298537172.36372.49
63193448-319344877.40677.55
20min13603653-360365387.34987.572.5587.6187.822.54
23648280-364828088.43188.68
33658920-365892088.68988.93
43735325-373532590.54190.80
53466182-346618284.01784.27
63563884-356388486.38586.66
30min13983909-398390996.56696.652.8296.9797.062.81
23999919-399991996.95497.36
33978943-397894396.44696.84
44189717-4189717101.555101.97
53912372-391237294.83295.22
63860116-386011693.56693.99
45min14116696-411669699.785100.241.56100.35100.811.55
24133454-4133454100.191100.75
34182867-4182867101.389101.94
44230750-4230750102.549103.13
54103947-410394799.476100.02
64046081-404608198.07398.65
60min14167637-4167637101.020101.341.30101.75102.071.29
24186392-4186392101.474102.20
34230217-4230217102.537103.26
44226111-4226111102.437103.19
54193413-4193413101.644102.36
64082091-408209198.94699.68
极限14214364-4214364102.152102.211.50103.05103.101.48
24226469-4226469102.446103.34
34265757-4265757103.398104.29
44218619-4218619102.255103.18
54275271-4275271103.629104.51
64099097-409909799.358100.26
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%
113.908003180011800047997679901799850.07
213.898013380083801080.05
单位质量响应值RSD%判断
5754.325767.310.16数据可信
影响因素30天-供试品溶液-2024050521批-西格列汀-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%
5min117210-1721020.86717.5628.4320.8717.5628.43
218607-1860722.56122.56
311094-1109413.45213.45
49434-943411.43911.44
518586-1858622.53622.54
611948-1194814.48714.49
10min144028-4402853.38447.0119.5953.4247.0419.60
248082-4808258.30058.34
332344-3234439.21739.24
430252-3025236.68136.70
544442-4444253.88653.92
633482-3348240.59740.62
15min165295-6529579.17171.0514.8779.2971.1614.88
269355-6935584.09384.23
351045-5104561.89261.98
448984-4898459.39359.47
564353-6435378.02878.16
652577-5257763.75063.84
20min176943-7694393.29484.159.9993.5584.3810.00
274589-7458990.44090.71
363377-6337776.84577.04
461572-6157274.65674.84
575343-7534391.35491.61
664586-6458678.31178.51
30min179712-7971296.65192.053.4197.0692.423.44
275588-7558891.65192.08
373135-7313588.67789.00
474064-7406489.80390.11
578380-7838095.03695.45
674646-7464690.50990.84
45min180070-8007097.08594.971.9797.6695.481.98
277085-7708593.46694.04
375943-7594392.08192.55
479407-7940796.28296.73
578990-7899095.77696.34
678436-7843695.10495.58
60min180512-8051297.62195.822.2998.3696.502.26
276159-7615992.34393.08
377701-7770194.21394.83
480978-8097898.18698.80
579289-7928996.13896.87
679508-7950896.40497.04
极限180803-8080397.97496.382.5698.8797.212.53
276521-7652192.78293.67
377841-7784194.38395.16
482171-8217199.633100.41
579723-7972396.66597.55
679849-7984996.81797.62
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20
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%
119.534257255425761542585414255729425402542566330.05
219.554253550424417942488640.16
单位质量响应值RSD%判断
217953.56217333.200.21数据可信
影响因素30天-供试品溶液-2024050521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%
5min11154648-115464828.05824.0822.9628.0624.0822.96
21210165-121016529.40829.41
3804607-80460719.55219.55
4708519-70851917.21717.22
51214744-121474429.51929.52
6852511-85251120.71620.72
10min12579164-257916462.67556.0716.5662.7256.1116.57
22781846-278184667.60067.65
31990128-199012848.36148.39
41872210-187221045.49645.52
52575206-257520662.57962.63
62044849-204484949.69149.73
15min13579789-357978986.99179.4212.5087.1479.5512.51
23788890-378889092.07292.23
32919273-291927370.94071.05
42809570-280957068.27468.38
53513840-351384085.38885.54
62997382-299738272.83872.96
20min14070931-407093198.92591.238.1599.2291.498.17
24015259-401525997.57397.89
33498496-349849685.01585.25
43397851-339785182.56982.79
54001443-400144397.23797.53
63540461-354046186.03586.27
30min14185939-4185939101.72098.292.43102.1898.712.46
24062344-406234498.71799.19
33937649-393764995.68796.06
43964391-396439196.33796.69
54128247-4128247100.318100.78
63990874-399087496.98097.36
45min14201043-4201043102.087100.771.18102.72101.361.18
24102270-410227099.687100.33
34076825-407682599.06999.60
44191533-4191533101.856102.37
54153432-4153432100.930101.56
64156859-4156859101.014101.56
60min14219510-4219510102.536101.411.52103.34102.161.49
24081656-408165699.18699.99
34127987-4127987100.312101.01
44257382-4257382103.456104.14
54160850-4160850101.111101.90
64190661-4190661101.835102.55
极限14213200-4213200102.383101.561.75103.35102.471.71
24079351-407935199.130100.10
34126968-4126968100.287101.15
44290138-4290138104.252105.11
54168471-4168471101.296102.26
64197121-4197121101.992102.87
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%
113.908013080129801438005280123801150.05
213.897982779824798260.01
单位质量响应值RSD%判断
5763.675747.010.21数据可信
影响因素30天-供试品溶液-2024050521批-西格列汀-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%
5min112589-1258915.27915.907.4515.2815.907.43
212819-1281915.55815.56
311598-1159814.07614.08
413573-1357316.47316.47
514378-1437817.45017.45
613647-1364716.56316.56
10min134804-3480442.24042.924.6942.2742.944.69
236020-3602043.71643.74
334667-3466742.07442.10
432731-3273139.72439.75
537411-3741145.40445.43
636539-3653944.34644.37
15min153538-5353864.97765.974.3765.0766.074.37
254582-5458266.24466.34
352837-5283764.12664.22
451090-5109062.00662.10
557026-5702669.21069.31
657069-5706969.26269.36
20min166617-6661780.85081.333.7881.0581.543.78
267983-6798382.50882.72
366398-6639880.58580.79
462577-6257775.94776.14
568653-6865383.32183.54
669869-6986984.79785.01
30min178172-7817294.87492.033.2495.2192.373.24
274706-7470690.66891.01
374508-7450890.42790.76
472124-7212487.53487.86
577137-7713793.61893.98
678315-7831595.04895.41
45min180895-8089598.17995.652.1198.6896.142.11
278227-7822794.94195.44
377998-7799894.66395.15
476438-7643892.77093.24
578827-7882795.66996.18
680464-8046497.65698.17
60min181275-8127598.64096.711.4499.3097.371.44
279514-7951496.50397.16
378430-7843095.18795.83
478947-7894795.81596.44
579065-7906595.95896.63
680885-8088598.16798.85
极限181539-8153998.96197.481.2899.7998.301.28
279797-7979796.84797.66
378800-7880095.63696.44
480896-8089698.18098.96
579794-7979496.84397.68
681085-8108598.41099.25
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20
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%
119.534256232425390842566234254586425421842551130.03
219.554252980424396842484740.15
单位质量响应值RSD%判断
217875.73217313.250.19数据可信
影响因素30天-供试品溶液-2024050521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%
5min1854873-85487320.77821.606.6420.7821.606.64
2871470-87147021.18221.18
3799466-79946619.43219.43
4932033-93203322.65422.65
5964050-96405023.43223.43
6909644-90964422.11022.11
10min12069065-206906550.29151.244.5350.3351.284.53
22140432-214043252.02552.06
32078957-207895750.53150.56
41958065-195806547.59347.63
52235514-223551454.33654.38
62166438-216643852.65752.69
15min13001736-300173672.96074.113.9273.0874.233.92
23060432-306043274.38774.51
32979485-297948572.41972.54
42884372-288437270.10770.22
53193962-319396277.63277.76
63174704-317470477.16477.29
20min13605205-360520587.62888.213.3087.8788.463.30
23661947-366194789.00789.25
33613553-361355387.83188.07
43416630-341663083.04483.28
53726285-372628590.57190.83
63751805-375180591.19191.44
30min14115830-4115830100.03997.722.75100.4398.122.75
23958301-395830196.21096.60
33984676-398467696.85197.23
43845883-384588393.47893.85
54095577-409557799.54799.96
64123365-4123365100.222100.63
45min14236848-4236848102.980100.971.78103.53101.531.79
24107409-410740999.834100.39
34138334-4138334100.586101.13
44041668-404166898.23698.76
54178423-4178423101.560102.14
64223166-4223166102.648103.22
60min14254052-4254052103.399101.861.14104.12102.581.15
24160828-4160828101.133101.85
34156392-4156392101.025101.74
44140081-4140081100.628101.32
54190821-4190821101.862102.61
64242848-4242848103.126103.87
极限14262899-4262899103.614102.280.90104.51103.170.90
24170319-4170319101.363102.25
34164650-4164650101.226102.11
44209376-4209376102.313103.17
54205803-4205803102.226103.14
64234975-4234975102.935103.85
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%
113.907994879931798607993379973799290.06
213.897993079907799180.03
单位质量响应值RSD%判断
5750.295753.640.05数据可信
影响因素30天-供试品溶液-X022139批-西格列汀-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%
5min123659-2365928.73127.147.7628.7327.147.77
219567-1956723.76223.76
322423-2242327.23027.23
422003-2200326.72026.72
521833-2183326.51326.51
624628-2462829.90829.91
10min151736-5173662.82759.188.4362.8759.228.43
241923-4192350.91050.95
348091-4809158.40058.45
447151-4715157.25957.30
549750-4975060.41560.46
653729-5372965.24765.30
15min167890-6789082.44478.254.4582.6078.404.46
259220-5922071.91572.04
364221-6422177.98878.13
464808-6480878.70178.84
564772-6477278.65778.80
665731-6573179.82279.98
20min171249-7124986.52385.482.9186.8185.752.92
266354-6635480.57880.82
370875-7087586.06986.34
471553-7155386.89287.16
571904-7190487.31887.59
670417-7041785.51285.80
30min174336-7433690.27289.452.0590.7189.872.06
271190-7119086.45186.83
373040-7304088.69889.11
474113-7411390.00190.42
575709-7570991.93992.36
673578-7357889.35189.79
45min175644-7564491.86091.861.3592.4492.421.36
274380-7438090.32590.85
374533-7453390.51191.07
475891-7589192.16092.73
576524-7652492.92993.50
676870-7687093.34993.93
60min175547-7554791.74293.001.1792.4893.721.16
276951-7695193.44794.12
375420-7542091.58892.30
477209-7720993.76094.48
576818-7681893.28694.02
677572-7757294.20194.94
极限175600-7560091.80693.301.3292.7094.171.31
277264-7726493.82794.66
375479-7547991.66092.53
477622-7762294.26295.14
577323-7732393.89994.78
677683-7768394.33695.23
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20
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%
119.534260431425965042608684261651426375042612700.04
219.554256969425036842536680.11
单位质量响应值RSD%判断
218190.99217578.930.20数据可信
影响因素30天-供试品溶液-X022139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%
5min11564182-156418237.96835.896.5337.9735.896.53
21330273-133027332.29032.29
31481129-148112935.95235.95
41441647-144164734.99434.99
51452486-145248635.25735.26
61601841-160184138.88238.88
10min13050672-305067274.05170.197.2774.1170.247.26
22559283-255928362.12362.18
32850703-285070369.19769.26
42783245-278324567.55967.62
52953169-295316971.68471.74
63151511-315151176.49876.56
15min13822591-382259192.78888.723.7192.9788.903.72
23417599-341759982.95783.11
33637230-363723088.28888.46
43638274-363827488.31488.48
53682105-368210589.37889.56
63732703-373270390.60690.80
20min13978634-397863496.57595.472.2796.9295.802.27
23760082-376008291.27091.57
33944829-394482995.75596.08
43951158-395115895.90896.23
54015643-401564397.47497.80
63949109-394910995.85996.20
30min14120434-4120434100.01799.191.64100.5299.671.65
23990004-399000496.85197.30
34047413-404741398.24598.73
44075444-407544498.92599.40
54187319-4187319101.641102.13
64096482-409648299.43699.94
45min14173383-4173383101.303101.271.13101.97101.911.14
24132089-4132089100.300100.91
34118587-411858799.973100.62
44152323-4152323100.791101.43
54220717-4220717102.452103.11
64233948-4233948102.773103.44
60min14172687-4172687101.286102.261.01102.12103.071.00
24234388-4234388102.783103.56
34154787-4154787100.851101.66
44211348-4211348102.224103.04
54234837-4234837102.794103.62
64268136-4268136103.603104.44
极限14171100-4171100101.247102.361.09102.25103.351.08
24242886-4242886102.990103.94
34152451-4152451100.795101.78
44219752-4219752102.428103.41
54248779-4248779103.133104.13
64266260-4266260103.557104.57
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%
113.907982979811798357979479845798230.03
213.897997180000799860.03
单位质量响应值RSD%判断
5742.665758.530.20数据可信
影响因素30天-供试品溶液-X022139批-西格列汀-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%
5min114843-1484318.02922.2914.7718.0322.2914.76
220297-2029724.65424.65
317029-1702920.68420.68
416577-1657720.13520.14
519117-1911723.22123.22
622240-2224027.01427.01
10min135869-3586943.56946.429.4943.6046.469.49
239113-3911347.50947.55
336619-3661944.48044.51
435350-3535042.93842.97
545124-4512454.81054.85
637245-3724545.24045.29
15min153682-5368265.20567.876.4765.3167.986.47
257184-5718469.45969.58
354256-5425665.90366.01
453292-5329264.73264.84
562692-6269276.15076.28
654149-5414965.77365.89
20min167179-6717981.60081.853.2281.8182.083.22
270438-7043885.55885.79
366163-6616380.36680.58
465532-6553279.59979.81
569637-6963784.58584.84
665367-6536779.39979.63
30min175622-7562291.85590.342.1792.2090.702.16
276906-7690693.41593.79
372950-7295088.61088.96
474211-7421190.14190.49
573789-7378989.62990.03
672775-7277588.39788.76
45min178760-7876095.66793.741.4796.1794.261.47
278175-7817594.95695.49
375978-7597892.28892.79
477040-7704093.57894.07
577128-7712893.68494.23
675978-7597892.28892.80
60min179398-7939896.44295.510.7297.1096.180.72
278658-7865895.54396.24
377842-7784294.55295.21
478641-7864195.52296.17
579059-7905996.03096.73
678196-7819694.98295.65
极限179581-7958196.66496.340.7397.4897.170.73
279020-7902095.98396.83
378355-7835595.17595.99
479292-7929296.31397.12
579981-7998197.15098.01
679676-7967696.77997.60
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20
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%
119.534255854425588442577694256465425731342566570.03
219.554256581424886842527240.13
单位质量响应值RSD%判断
217954.79217530.640.14数据可信
影响因素30天-供试品溶液-X022139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%
5min1972538-97253823.62226.307.7723.6226.307.78
21150751-115075127.95127.95
31051319-105131925.53625.54
41018686-101868624.74324.74
51196412-119641229.06029.06
61107127-110712726.89126.89
10min12174515-217451552.81855.597.8252.8655.637.82
22337006-233700656.76456.81
32213451-221345153.76353.81
42149722-214972252.21552.26
52629216-262921663.86263.91
62227328-222732854.10054.15
15min13055380-305538074.21376.815.3374.3476.945.34
23230666-323066678.47178.61
33086021-308602174.95775.09
43053393-305339374.16574.29
53477978-347797884.47884.63
63070285-307028574.57574.71
20min13686316-368631689.53890.012.6889.7990.282.69
23855866-385586693.65693.93
33644177-364417788.51588.77
43628243-362824388.12888.38
53800646-380064692.31592.61
63619198-361919887.90888.17
30min14068806-406880698.82997.611.8699.2398.021.85
24133357-4133357100.397100.82
33946152-394615295.84996.25
44030274-403027497.89398.29
53989751-398975196.90897.36
63942878-394287895.77096.18
45min14203334-4203334102.096100.621.21102.66101.201.21
24189537-4189537101.761102.36
34083792-408379299.19399.76
44153509-4153509100.886101.45
54137032-4137032100.486101.10
64087776-408777699.28999.85
60min14225509-4225509102.635102.030.61103.37102.780.61
24208807-4208807102.229102.99
34162585-4162585101.106101.84
44215438-4215438102.390103.12
54216114-4216114102.407103.19
64175884-4175884101.429102.16
极限14231557-4231557102.782102.540.54103.69103.450.55
24218613-4218613102.467103.40
34177803-4177803101.476102.37
44235701-4235701102.882103.78
54239971-4239971102.986103.94
64225534-4225534102.635103.54
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