usp 41 Sond pei. whee de roi Remar, en ur a (ae enema Pea op Sere Pe esas Seana N cate GFR ay IS tt Ay pin Besa te estore oa SE SPT acre hy Fe pantie, tons mn at (one toma St Par cn Sea ie ee ay RSs Serie cter aaa Seino smange meres SES RS TR en itil toes ete ie Cee Bote eg sie etar fly hammer c= (2) Repeat procedure (), but substitute 1.0 ml. of boric sili Fear tovateed tea moemcne a Cee procaeare (or, but sae 5.0 mL of the tee sree (0 staat Designate the absorbance as 4s. - Gas RUE! S sine 0m ll Pasa imal Base ES Sy nn pin cint Stes eR RS per a 1g of pyridoxine hydrochloride sige VOCCIIAy — ADI (As AD in which Cis the concentration, ing per ml, of USP Pye Gouine Fyarochionde RS nthe’ Seandardproparanony Vie the volume, in mly of injection taker; and the other terms ae as defined above. Pyridoxine Hydrochloride Tablets DEFINITION Pyridoxine Hydrochloride Tablets contain NLT 95.0% and. 'NMT 115.0% of the labeled amount of pyridoxine hydro- chloride (CsHiiNOs - HC. IDENTIFICATION. PR REncTION wT Fenelon ‘Samples Equivalent to,100 mg of pyridoxine hydochio- rie ror s quently of powered Tebers, Analysis Add 3 ml of water tothe Somple. Shake the Tire iter info a text tube, and add 2 ox 3 drops of ferme conde 1S ‘Acceptance criteria: An orange to deep red colar is produced ee assay Procure Baer" Diulve 16 of anmonium chlor n 7 mk cf water a0 Teme of amoniun hysoseey ate seiner to 1001 ard er Color feagent: 04 might. of 2 6-dchloroquinane ‘chore kopropyt soho (Noe Store te solu- fia regent ad cee vat one mon Bo Po abe the Suton has bec pk) Official Monographs / Pyridoxine 3527 on aae resi relis: ile ar ei needed.) a ‘Sample solution: Weigh and finely powder NLT 20 ee graiee eea e aer See recue (See Ultraviolet-Visible Spectroscopy (857).) re eee text tubes, and fin succession, mixing ter each for 10's, accurately fed. Determine the absorbance Gi tecuenaa encarta, Bieta aoe eee tee Pee IAS ged seed GRC (Au ~ ALIA ~ Ad) x (Cala) > 100 4, = absorbance of Sample solution with water ‘4d = absorbance of Sample solution with boric acid 4, = absorbance of Standard solution with water Ai = absorbance of Standard solution with Boric G = concentration of USP Pyridoxine Hydrochloride RS in the Standard solution (ug/mt) y= nominal concentration of pyridoxine ihycrochloride in the Same solution (ug/ml) ‘Acceptance criteria: 95.096-115.0%6 repre e TRERRINSE TET raked ompe 1 ee reat Candy Rane ew comatan US eee By, en sty Nee en * i Bese us om § z A A CI cI Es3528 Pyridoxine / Official Monographs System suitability jample: Standard solution Suitability requirements Relative standard deviation: NMT 3.0% Analysis Samples: Standard solution and Sample solution ‘Gelcblate the percentage of the labeled amount of py. ‘doxine hydrochloride (CyHy:NOs » HCD dissolved Result = (nln) x (Cex D« VIL) x 100 fy = peak area of pyridoxine from the Sample solution 1) = peak area of pyridoxine from the Standard ‘olution G__= concentration of USP Pyridoxine Hydrochloride Re ine Stondord sobrion (ma) sip ution factor for the some salina lume of Mediu, 900 Th abel cam (gy able) Tolerances: NLT 759640) of the labeled emaunt of py idoxne hydrochloride (CHHyNOb HCD i dove + nronmry of Dosace Unifs QOS) Mest the requrements ‘Cdntent uniformity ‘Sindarin 10 al of USP Padoune iy. crochlonige RS in cllute yaroctione aga (1 100) sample solutions Tanste? | ablettrely powdered, io Sbotmt volumetric Mask containing 900 of ter, shake for 30 min, and dilute with water to vol Ui, ier poo fhe nur deorig he Hist 25 nl ofthe vate: Bite an aiquot of the f- tate wit lute hyerochionc aid (1 160) to obtain TOugimt of pyridoxine Myarochlonde insthumnental Pondios {see Uitravole Vise Spectroscopy (857)) Atallial wavelength: 290 ‘Analytical wavelength: 290 rim cae tenn Blank: Dilute hydrochloric aid (tin 100) Anais “Jamples: Standard solution and Sample solution Determine the absorbances of the Standard solution and Some soln. Glleuate’the percentage of pyridoxine hydrochloride {GarhsNOs HO) in the portion of Tablet taken Result = (Au/Ad x (GG) * (1O0/L) ‘Ay = absorbance of the Sample solution bsorbance of the Standard solution Eanceivaton of UsP Pyridoxine yarochlode RS in the Standard solution (mg/mL) G)__= nominal concentration of pyridoxine hydrochloride in the Sample salution ibe dat (globe ADDITIONAL REQUIREMENTS PACKAGING AND STORAGE: Preserve in well-closed contain fr, protected fom ight. + USB Rerenence Sranpanos (11) USP Pyridoxine Hydrochloride RS usP 41 ine Maleate ‘1 “oka: mY Cty sO-CO. 401.46 ‘ Edthanedlaine,wimethonyphennethy LV imethyN-2-pyidinyt, (2-2-butenedioate (1:1), 212 (Oimethyiaminopetivcp- methoxybenzylaminolpyridine maleate (1:1) [59-33-6]. » Pyrilamine Maleate, dried in vacuum over phos- phorus pentoxide for 5 hours, contains not less than 98.0 percent and not more than 100.5 per- cent of CrzHasNsO AHO. Packaging and storage Preserve in oh, ghtreitant USP Reference standards (11)— USP Pyrilamine Maleate RS Identification— ‘A Infrared Absorption (197%). 8: Utrewolet Absorption (197U)— Solution: 10g per mt Medium: 0.5 N sulturc ai. Absorplvties at 236 nm and 312 nm, calculated on the rie Batis, do not iter by more than 3.0% Melting range, Class (741): between 99° and 103+. Loss on drying (731)—Dry it in vacuum over phosphorus pertonde Br Shou lest not more han O88 Ts wreig Residue on ignition (281): Related compounds— test = Standard solution Dissolve an accurately weighed quan tity of USP Pyrilamine Maleate RS in a mixture of methanol and ammonium hydroxide (200-1) to obtan a solution hav ing a known concentration of about 0-4 mg per ml. Quan ‘atively elute this solution with the mixture of meihanal 8nd ammonis hydrexice (200:1) fo obtan Stondard solu. tions A 8, and C having the following compositions rot more than 0.196, Percentage (for com ‘concentra. parison with Standard tion (mg of "test spec: ‘olution Dilution RS par men 4 ind) on os a Gin2) 0.06 03 Test soluton—Dissolve an accurately weighed quantity of Pyrlamine Maleate ia mintare of methanol an ammo ‘lum Rydraxide (200) to obtain a soluton having 2 Known concentration of about 20 mg pet ML uant: ethyl acetate, diethylamine, mhexane, and methoral (93:714), Procedure—Apply separately 10 ul of the Test solution and Jolubef each ofthe tee Sie testo a sutable thvlayer chromatographic pate (see Cemate {62')) coated wth 2 025.1 layer of chromatographic sl {ea el mistre’[nore—“the pate has been prewathed for Zhauts with Ent and dred] Alow the spots on the plate {olay Pace the plate na chvomatagraphic chamber and