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Trang 11- -
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b ±5- . %. sovai kh6iluqil-".gghi tieQ::.Man A ±5% ~ov&iKLTB :/: ' , (_t {! 1 h ~ ' J: \Vi
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Trang 2! -£>t Q~aisf, chopMp my tlieo KLghIir~li~biin
: ~ @D~ n&, k1iting co don vj thu n a o c6kh6i jlI\1l1gi~chia ngoai quy dinh ~
; quy dinh va IAnthfr l~i ' v6i 5 dan vi khac d~u d~t ' .
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: c Didneu c6 I don vi trong so 5 don Vi thu co kliOillI!}l1g I~hra ngoai quy djnh
d Da n~u kha~ c6 40n vit bth ll o tron Han vido ' n ii I '0 cokh6i 11l'O'D
11.Ki~m ngIii~~ d9 d5ilg d~u KL c~ th u6 cb¢t,thu6c c6m
~: Sai.l cho pMp tuy theo KL ,hi tr@n dfiF ; ' r ;/iii ;:; ~(
d Rhona d~(Ycco ' u ' a2 don Vi t o ' kh 6 i hrun - n i m :n iOi ban chenh lech
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a GiOi han c60phep tuy theo kh6i ltroug gl:J.ifreD ;nbi~ , "'~":('OI?C ,,' -:f \ 0
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19 Trong ~hi tieuxac dinh mini sAcella thli5c tiern.•.hoach~tdung depha dungdich, ' mau : dc\ 1~ " " , ", (,0 //1." , , "f'! -',L; ~'" " ,', "
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21 Xac dinh dQ!lang d~u'p~i nu~u cU21,h~6c'}!;Iimfii d~uti€~h~mhv6i
Trang 424 Trong chi tieu xac dinh mau s~c cua thu6c tiem, dung moi ctipba du~g dich aiu
=: ~~q~ cit 11cI- ty. "£Itt- + 9 ' r r~ _ -JItp - c:: "J{ : - -
la 975ml nuoc cdt va ·25 mlHCI-~· pha diroc dung dich HCl 1% :0; · rnadapan
A.IO chai
C Siro
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Trang 637 KiSIll nghl~tp : ~6\¬ ii f gBm - ~acchi ti~ sau
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B.D(ItronlJ,giOi han kfch thll'tTc h"t, sai s6th~ tich, d(l viltmng ",_
c dim h{Ulcacphfut illkimloai
D DQtrong, gi6ih~ ' ldch thirec hat, kfch thuac cac tiSu phan
; , · ~ (c
3& '" I" I ph!ncua miu (ciru ???) (cAn deph4u tich cua phOng.kiem nghiem) ( ???) phai
dn ~ thuc hi~ <fa')' d1itdt 'Cft cac phep thntheo yeti edrr ttlriieuchu!n cbAt-Irt(mg
B Miu d5i·chieu
c Mau thu
D Miu phillltl~h
'
39 ThuBe·co v~t Ii~u J?ao blhlnhdmg dap~gnhu cAudam Mp ch§t !UQiigthu8eIa
A Thuc3c kern chat lugng
B Tbuc3c cAndang kj l~i
y - Thuc3c gia · : · >
-D can phaithu h6i
40 MAulUll phlti dugc luu gift dAydti hOi nguu; liy mau (sa Ian 7??), cae chi lieu trong
-A Miu ph~ tichphai coit nh~t3ph~n kiSm nghi~m
B ~Tuy thuQc v ilonoi giao m§u s6 h.:rQl1gnh?p
c _ it nb§t P-b.!_i a u ~ - lin ki~m nghi~ni
D Tliy thu9c."~o no; giao m~u_
Trang 71
Trang 8A Tieu chu4nphong chua m~u
Trang 950 M.1 ph§n cua 10san xuAtnhu'1 86goi, 1s6h9P hay 1s5thung nguyen veri ho~c; ,
D cse cftu tren d~u d~ng
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d Khong tfnh thOi gian
h S::mkh1 hn:?in th~~h rAna Arv;m nh~ (''h~
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chon mAu ng~u nhien., , ' ,
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d Xem ket qua kiem nghiem dong nhat, cac mau nguyen li~~gQP lai thanh 1 mau .hru
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a Vi~n ki~m nghi~m
Trang 13·b.· B9-YT~
.'.~~·,C~'quan-kiSm nghiem
d.Tuy dia phuong
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67 Vi trilay miu phai sach,~9i tnrong xung quanh khong dl1gcgay nhiem ~fut lamthayd5i tfnh ch~tcua m~u,Dhiet dQ, dQAm,anh sang, , dAngfum : khong'demiu t~c;d¢~g 4~n
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a TV'kiSmtra ehAt Iucng thu6c cua co s(1san xuAt
,b Tirkiem tra chAt luong thu6c eua:co saillng~Oi san xu~t.
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-68 N&':l n= 30 thls6 ami vjlAy miu 1a
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Trang 14a/sd tay ~hdthrong phong thi nghiem
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Trang 15cYkhi aahoan tMgiai doan d6ng g6i
dIkhi vua vao chai 19xong
76;~i~n ~6~~~ie~ ' nan{c0~o~tchAtthi ' s& ~ i~ ~ ~ ; don g v(t hanh phitn i! ) / dft \i : ngu&~ :: · ; ~ : · :; /P
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43
Trang 16a/tai cty san'~~t thu6c
S)t~i'ca ~adtigc I~y miu " a coquan kiSin nghi~m,t~i co quan quanIl kiSrntra chAtIUgQg
dJi~iso·yta · ,t~ , caquankiem nghiem.ta] co quanquan li
' :' - ' - iiiy thea quy dinh cua phap lu~t chotA ehirc ca nhan hithi~thlii do KQ ki~m nghi~m sai '
!!(H~ - ih?p:g · ~oallh~ihi~p- }~. nghj,~pV1jk~Sm~ghi~~~;, '",
b/CAc ~ e~ ki~~ nghl~~ , "'
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Trang 17-"' , _' . ','.:-' .
a;tinh d~c'hi~; de>xacgan "dQ dung;' mien gift tri, t~ tuy~n ;tinh
:Q.tinh'd~chi~~,d<)chinh xac, de> dung, mien giatri va tinh tuyen tinh '
c.tinh d~chi~u, ell) chinh xac, de>dung;gi6i han dinh.lugng,' ~i~n gia : tri va tinh tuy~n
Trang 18dILUQng th~p Dh~t cua chAt cAn thirtrong m:!u COlIco th6 dinh hrong du'<;1c
88 DQ l~i i~pbi~u thi dQ ph6~gthich khithay d5i
a/Phong thi nghiem va phong ,phan tlch : '
9.0 DQ chinh xac trung gian Ia
ltl DOchlnh xac cua qui' ~rlIihtheo cac bi~n_s6cua rh9t phong thi'nghiem (:;
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Trang 19' ; ' ' ~
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trong thul>c danqua da thi khong can phai thu , ' '
a) p~ dangd~u.kh6ilUQngmiSngtp.u6cdan
III B9 d?hg d~u khAi luong lop chea hoat c~At
c) f1Q-dong (teu die ntlchT"
Trang 2351
Trang 255
Trang 27- 55
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Trang 31thuoc bot?
kh6i lugngellathu8cbQt?
38.Anh (Chi)ha , ytruili bay each thirvayeuc~u IcYthti~tv~0:9 d6ngd@ukh5ilUQ'Ilgcua thu3evien.nangj":
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Trang 32Na2~203 O,lN coK;i,qD76.Bi~t rfuJ~ cinl~dQ lO,OOml dung dich Iod trenvai chi thi
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Neu mQt vien ": Tolbutamid , duge hoa tan trong nucc va hoa Ioang t~ dU2500ml thlde) hap
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