%PDF-1.7
%
54 0 obj
<>>>/Metadata 118 0 R/OpenAction 55 0 R/Outlines 49 0 R/PageLayout/SinglePage/Pages 50 0 R/Type/Catalog/ViewerPreferences<>>>
endobj
118 0 obj
<>stream
application/pdf
©2014 Thermo Fisher Scientific Inc.
Advances in instrument technology now mean that in certain circumstances direct transfer of complex, multivariate, quantitative NIR models between instruments is achievable.
In the case study discussed in this report, a method to quantify a minor polymorphic form of an active pharmaceutical ingredient, within a complex capsule formulation, has been successfully transferred between an Antaris I MDS NIR analyser and an Antaris II MDS NIR analyser. Statistical tests have been used to show that the same models on both the donor and receiving instruments gave equivalent results without the need for corrective algorithms or correction standards. The ability to perform a direct transfer has greatly simplified the transfer process for this GMP method and also saved considerable time and expense in the preparation of new calibration and validation standards
Antaris
Near Infrared
Quantitative Models
Method Transfer
This application note discusses how AstraZeneca was able to perform a direct transfer of a quantitative model for a minor polymorphic form in a drug product between two Antaris Method Development System (MDS) NIR analyzers without the need for a correction algorithm.
2014-11-07T11:43:49.346-05:00
Stephanie Brookes,AstraZeneca,Macclesfield,UK
Direct Transfer of a Quantitative Model between Antaris FT-IR instruments
1218528
fc52190c2b3c4c236170b49489a3ca974eae3afc
2014-11-07T11:41:55.763-05:00
Adobe PDF Library 11.0
False
Stephanie Brookes
2014-10-30T15:12:26-04:00
2014-10-30T15:12:22-04:00
2014-10-30T15:12:26-04:00
Adobe InDesign CC 2014 (Macintosh)
proof:pdf
xmp.id:92a83f05-bd76-4ada-9b61-9da0e23c5377
xmp.did:A9CC217428206811822AE847A0C17DD4
uuid:97151c3f-ba29-fe44-9945-597bb8e89d5b
default
xmp.iid:bc13af73-46f4-4fcb-b71e-bebbfe1357d8
xmp.did:1c08e185-fe0f-4199-951d-d17c0efe7897
xmp.did:A9CC217428206811822AE847A0C17DD4
Antaris; Near Infrared; Quantitative Models; Method Transfer
Adobe PDF Library 11.0
False
document-taxonomy:scientific-resources/application-notes
True
endstream
endobj
55 0 obj
<>
endobj
49 0 obj
<>
endobj
50 0 obj
<>
endobj
56 0 obj
<>/ExtGState<>/Font<>/Pattern<>/ProcSet[/PDF/Text/ImageC]/Properties<>/XObject<>>>/Rotate 0/Tabs/W/TrimBox[0.0 0.0 594.0 792.0]/Type/Page>>
endobj
1 0 obj
<>/ExtGState<>/Font<>/ProcSet[/PDF/Text/ImageC]/Properties<>/XObject<>>>/Rotate 0/Tabs/W/TrimBox[0.0 0.0 594.0 792.0]/Type/Page>>
endobj
11 0 obj
<>/ExtGState<>/Font<>/ProcSet[/PDF/Text/ImageC]/Properties<>/XObject<>>>/Rotate 0/Tabs/W/TrimBox[0.0 0.0 594.0 792.0]/Type/Page>>
endobj
18 0 obj
<>/ExtGState<>/Font<>/ProcSet[/PDF/Text]/Properties<>>>/Rotate 0/Tabs/W/TrimBox[0.0 0.0 594.0 792.0]/Type/Page>>
endobj
26 0 obj
<>/ExtGState<>/Font<>/ProcSet[/PDF/Text]/Properties<>>>/Rotate 0/Tabs/W/TrimBox[0.0 0.0 594.0 792.0]/Type/Page>>
endobj
32 0 obj
<>/ExtGState<>/Font<>/ProcSet[/PDF/Text]/Properties<>>>/Rotate 0/Tabs/W/TrimBox[0.0 0.0 594.0 792.0]/Type/Page>>
endobj
33 0 obj
<>stream
HW]oJ}ࣴV4},m^M]<+K$'=dYN Sk^IJ63d RjbxuPÎK5zX
iQI:$A$]n;7|Ve+eSǦsduߡ6
SF1`
P6ݒ
脒(T'}02
K^t Quq=|L2d{uTvuuO+6uS5wT7uyM&'
(9e[]/zѪl]m^wkR*Qe}7y[{Fyݗ=p?h۬\ѕoGtuWZgswž܊ou9"oCKuҮM۔vˮ#y!6y? S$ +nݪO4h;D}Ծ>cS-GT7
c3rw[nJ$L)W/ =}x}qb6RAfQ'j%,$Bu^\ՉnQ.["R
Abu k9^ђ.ߺPWMrj8v
Bs]7~DUbP
X+.!o,PI"=ljn>\VLnZlyUjcl϶6dѠ,rvt UYmZar7y0\`kރ3] _(Cm6L-IJ݇O?hC CWpʕk/BpwF-{CaqۡkwʫD:U>,$#}Qc4St
9{n%kLjÏ?)\274G'A69P\qAJC*ԫ郼E_kF+tX:TG/G{lߛpS4
woPX#EY#㨰-36l^!;J!k(
z"n=d؉zܵ(c]0zNc&gB@yQ 1!`cA$8a_-cf!x_|=RhWɸLH~$)- g%tyfi$px;QPfL.%(MHGEG!(6(Մ{))ɐ6&LK:~;xNH̊5;KcdA5q{nK2ˍT,0C,uډf pt89mcymԎOXvF,?fl5go_
Eq6I +su:5DK{Q>\N˒{!nJա9K""`_'i}ҪBҦByuc2
>+a-CY
e.l>˝oع`a|9NSŋHx(sg>p&Kqu&S }JPnC!҂e=O% [S^OXp
6?F$d82?CJxSO)wc龂0qjv;2tK&p]T#)+>JF3$G YcGDr+MK<>3I`i~=$9~d0E'WpNΕe 9+Tb~?b?,
>isBh[ė~?TR\;o8CJꋝfcfn' t'gXEs#<<7sX1ֱ(h!6p$9+H:f25xm9JŹ>7or8Q'~'Tvf]/С!8dZ%Ch:B~6hAS**z09jq'^]JlCnvi(rDS7(aVlo|:!K=3'̇G{\p?bqb;WD[ %6!S ?q@Gd\PhdZxAzz)8"ŃCܬ8ּ /&ƿ#+W]Bm0F4h46m&~qy^竧%EgZBQĢRp>2|SO^t3@Ah MS_Y.(]1y1v6o$P*BⓢdZJ@b*+;mvn~ڧAS6_)۲zuio[r5%4UOQ]EϫK۷af/^WiqƜlH˱$31dmwOoۼ.JZܫ#cgV\' O^"LIY|2Vj[۸
<.S!<ʎbbH.W!)p.%+_3}!;3gW3o=2@E.2;_ylT'AG'*>}] }\2/a{v۞r9bBC7؞VU;lb뱯_mgq`us!f7='3AA2)}0H?տ[ya0ix[yFVYx,.aؾYF1ŵsC͔V0@; 0HB\Vp_AI0Y~|sLi?<&/SRbEƸ/{৷/dM
N~ڌhZS(ͦj8Oh#SVuBK戶Mg_76 .}ySd[_]>t8[pqi0u8uOi\aQW^J昜EȬ[gS{&'nq?~^ńzȝ?f^
O!qh;ZzwͶఫ?wce1olkkw]0GYfͮar#G~S>á~+`s
A߶FKlHj<-/w?>deƱ^d1lw}z_( s#N/䐟ٮ)On
قޟj7Hk\Z鵉]
^u;˃P0N3Wבo0zw0a;L>%*f}9s/]q]m+Q6V ~wߪ%# ڨec7tJśyEsKymjO%TxySY(:Cxb~9Pb"Ćq]h&+ xN/01CxGj@MZ03KSѠtUi#6JGXC*3#ߕrkjr ZX
GXQQ(Α
Ä
ƎaƨڑM-6inovU`O1L]}HI>Y )o|EŇpO 4y2GZE5 507b4}g8g@s[`i;!mtoL_FBn<"(xk:+|Tx4IL@_+
.m2S`?3`?[7x :ܖ#c]K0'E-`I`Oս{ Wƾ j
3K-h
%a⯩!YA2Jt`5|-11 ,[*UȂSL.5xٕJ<߸&B(y֧,,haZd^j43*TG4IVpLl#"ʠnac?x
F8m@#g6:$QEKv)eֶJqoF}rm QFʁ~dAOkPs4(xDj}ģ#hk