Scribd
Upload
2K views3 pages

Usp 854

The document discusses the use of mid-infrared spectroscopy as a method for analyzing substances, detailing the operational qualification and performance evaluation of IR spectrophotometers. It outlines procedures for sample preparation, validation, and verification of analytical methods, emphasizing the importance of accuracy and precision in measurements. Additionally, it provides guidelines for ensuring compliance with regulatory standards in pharmaceutical testing.

Uploaded by

Raghuveer Reddy
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF or read online on Scribd
2K views3 pages

Usp 854

The document discusses the use of mid-infrared spectroscopy as a method for analyzing substances, detailing the operational qualification and performance evaluation of IR spectrophotometers. It outlines procedures for sample preparation, validation, and verification of analytical methods, emphasizing the importance of accuracy and precision in measurements. Additionally, it provides guidelines for ensuring compliance with regulatory standards in pharmaceutical testing.

Uploaded by

Raghuveer Reddy
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF or read online on Scribd
5/9125, 5:24 PM drugfuture.com/Pharmacopoelalusp38idataN38332/usp38n3382_c854.htmigoogle_ vignette GoDadey-com » SSL for your business ‘Ate fotowing: 4 ( 954) MIDINFRARED wrRoDucTION sina (md) specroscopy san msturaisl method used to masse hosts of lecvomagnet esto var the Wavenurbe" ange bewean £000 ana 400 en comasponding to mavlongs between 25 ane 25 um), Uns othr speed n& monograp or tervals procedre he regen ‘rom 300 650 eh (corsaponing to wavlong om 25 15 4) shoud be used arse eamlance We rangtaph speccasns far absorston ‘he ebsuptin of shen causes the pono of molecules om @ gourd sit of her vratonl mde an exe viatonal ae. \Voratenl ade re dtd bythe maton fa ate ia oleue When rolls cotsn cara nctonl rou, Rsberpon on cous n space ‘aro epecralranges. nthe css, th wavenumber thc haa anston esr af known a 09 aan Whan a weal os ve {tome motors of more an ue afew els, te equerces ci ove wie paca anges and tent cetactte cpu fuctoral cup out are ‘noe charactor of molcles 65 2 whol. Such bands ae hrown 8 ngurptntbards, Al s¥ong bends ta bso at wavenumbers above 1500 en" ae soup reqinces, Strona bande hat aber below 1600 cn" can be ee grup raquo parent bands For deausson ofthe theny ae princes ofmeacrerants, oe Mi Ina Sractosag— Thay and Paci (1854). which may al bt rt ‘QUALIFICATION OF IR SPECTROPHOTOMETERS. ‘ualtcston of mR specropotomst' I vied its tee eangorais:nstaten Quateston (0), OperetanalQuaiaton (0), ans Peormanco uation PO} Forte nfarmalin sea Anal isrmert Guten (5058) Instalin Quateson ‘The requtemenis provi viene the adware an ofr re propery alle inthe sed oct. ‘Operational uation Because he majesty of mii spect are measured wth Fauttstnstorm (FTIR) apecopolometa, cl tate inturant ibe acssad, RoTE-NO recommended values fo signal-o-noise rato or 100% line stably are inchided inthis chapter because these vary with ‘manufacturer, madel, and age of the instrument. “he mot commonly uses wavanumbe anda for spacrapotomer fan approximately 85 yn ‘hick, mat polshree fn The specru of sch fn has ‘oval sharp bands t 9609, 248 8428, 804.2. 1863.0, 11645, and 128.3 emi The most equeny hase band or wavenumber aceracy torino sealed 16012 om", Ung a stable plsiene im or ther wo characonrs wavenubes sla, san fom 300 ont! ‘raverumber, and eompare the wavensmber of maximum espone alte cater bars using the canara, penis proces, of tar peak icing soon tothe known sbsrrtor wavenerer ofthe sana. The asap lear forthe moasres waverberis 1.0 on Peromanes Gunfeston ‘The purse of peeancequiiaton (PC) eo detain Bale insrsnertis cable of mestng te user's reutmens oath parameters at my acne aly ofa massrerent ‘PROCEDURE: isi spac canbe mented by vanencin, tera rflacn,nterarfcton oflen cled ere tl efeton fee efleton, and paescouie specrescopy erent amps proparaonecniques ae arable fo theseoptons. The most carmonsargle para tecnques are preset blo. Potassium Bromide KB Disks Conan powdered aka ales sch eptassum bra, alas ch, an casa edi coalesce nd hn pressireandcan be ome et a ‘Sipping disks hs 9s varaparent a mis radian The skal hale roe commonly ured pawdores, dy, igh prepara brome, wreh ransparent tw mi radaton above 400 en” Commercial presto a sina ange of ssretrs ra aval rth peparaton of aka Mae ad sir ak, Mine Ot Male ‘type precast propars a mul st place 10-20 mg fhe samp roan apts rar. andthen gts sample prose powder sing 8 “nfo, whichis vansfoec oe carter fa chan IR-ransparer wow (e., polasium bromide, sd cle, vr bramie, of casinos. A sco ating wens plaead ant tha ml, he ll quaeze oor hn, nscale that feo buble. “The mot wily ute muting agent othe mi R regions 9 etal yerocarbon mineral i para, Neo Sot.Suppres Palmer Flms “The mR waneriasion sperm of many pahmers vad ne packagig mater te recone or samples prepared aston sel-ssporng fn sha eaten Fins Noni tude canbe examinad retin te form oa bin yer sanawched between wo aleing wows ha ae tanspaento misiR radiation. The layer must be feo of utes and must compel over te darter he IR eam fsssa on ha samp Ui nd Solana Tansislon Cae Forth exarinaton ould an slston somes, vanarisin cll assorls tha compres @ Window per, pacer lng pars ard aha are ovalete nipsfwewdrugfuture.com/Pharmacoposialusp38idataWv38932/usp38nf93s2_c864 him! 18. ‘5/925, 5:24PM

You might also like