XANTHAN GUM Xanthani gunimi [1138.66.2), DEFINITION igh-moleelar-mas sonic polysaccharide produced ty fementatlon of eaolydates wits Nanthomonas Compt Itconsss of principal chan of B(L->4) linked leas nis wih issn cay, on atereetng tbroplucose uns, consiting of glucwronle acid ualt iMeleded between 2 mannose unis, Mest ofthe ena ns CWntain a pyruvate moiety and the mannose sn adjacent C0 the principal chin may be aeyated a C6 Xanthan gun hasatlative molecularmas of approsicatly IN iot ens as the souium, pati or clam sal Cente: nim 1s per cen of pyran (CiH}0,: 54,701) eed substance CHARACTERS Appearance: white or yeowish-white, Hee Nowing power IDENTIFICATION ; ‘A Ina flat, suspend 1 gin 15 ml of 8.1 M hydrochloric acid Close the ask th a fermentation bul contsining berm hydroxide solution Rana heat eaeel (or 5 in. The Barkan byronide elution shows a white arid B. To 30 ml. of water, previously heated o 80°C and ‘ised rapidly with mechanical stern 00 ml beaker, Sept of mania agin yen ok Iisg of areb bean gum Rand hg ofthe substance to be cramined, Str until the mixture forms solution, avd then continue stirring for 30 min or longer Do not slow Discontinue stirring nd allow the mixture to stand fora least h A fn rubbery gl forms ater the temperature SropsBeow a0 °C bat no such gel forms in a1 percent Control solution of the sample prepared inthe same manner But omiting the carob Bean gum ‘Tests ' pH (22.3): 600 to 80 fora 10.0 g/L solufion in carbon dioxide fee water 2-Propanol. Gas chromatography (22.28). Internal standard solution, Dilute 0.50 of 2-methyl-2- ‘ropanol R to 500 mal. with water R Test solution. Yo 200 ml of water R in @ 1000 mL round-bottomed flask, add 5.0 g ofthe substance to be examined and 1 ml. of a 10 g/L emulsion of dimeticone Rin liguid paraffin R, stopper the flask and shake for 1h, Disti about 90.0 mL, mix the distillate with 4.0 ml of the internal standard solution and dilute to 100.0 ml with water R. Reference solution. Dilute a suitable quantity of 2-propanol R, accurately weighed, with water to obiain a solution having. known concentration of 2-propanol af about t mg/mL. To 4.0 ml of this solution add 4.0 ml ofthe internal standard Solution and dilute to 100.0 ml with water R Column = size: 1= 1.8 m, @ = 4.0 mm; ~ stationary phase: ethylvinylbenzene-divinylbencene copolymer R(149-177 jm), s Carrier gas: helium for chromatography i low rate: 30 m/min. Temperature: = column: 165 injection port at detedor; 200°C, Detection: flame ionisatiow, Injection: 5 ul. Relative retention wih refyrence to 2-propancl 2rmethyt2 propanol = sbout 5. Lint = 2propanol: masimum 750 ppm. oss o drying (2222): maximom 150 pee cent, determined fn 1000 g by dying inan oven st 105°C for 25h “otal ash (24.16): 65 percent to 160 percent. ASSAY Test solution, Dissolve a quantity of the substance to be xamined corresponding to 120.0 mg ofthe dried substance | Snwaier Rand dite to 20.0 mL with the same solvent. Reference solution. Dissolve 45.0 mg of pyruvic acid Rin water and dle to $00.0 ma with the same solvent. Place 10.0 mi ofthe test solation in a $0 mL round-bottomed flask, add 20.0 rol of 1M hydrochloric acid and weigh Boll on a wate-bath under affix condenser for 3 h Weigh and adjust to the ingisl mass with water R. Tn a Separating funnel mix 20 ML ofthe solution with L.0 ml. Of dinitrophenyliydrazine-bydrochlonc solution R. Allow to Stand for Sapin and ad 5) ml. of ethyl acetate R. Shake hd allow the solids to sete. Collect the upper layer and shake with 3 quantities, cach of 5.0 ml, of sodium carbonate Solution R. Combine the aqueous layers and dilute to 30.0 mL with sodium earbonate solution R. Mix. Teeat 10.0 mL of the Teference solution atthe same time and inthe same mann 45 for the test solution. Immediately measure the absorbance (2.2.25) of the 2olutions at 375 nm, using sodium carbonate solution R as ‘the compensation liquid. The absorbance ofthe et solution isnot less than that ofthe seference solition, which corresponds toa content of pyruvoyl troupe of not les than 1.5 percent FUNCTIONALITY-RELATED CHARACTERISTICS ‘This section provides information on characteristics that are recognised as being relevant control parameters for one or ‘more functions of the substance when wsed as an excipient (see chapter 5.15) Some ofthe characteristics described in the Functionality-related chgracteistcs section may aso be present in the mandatory pdt ofthe monograph since they tlio represent mandatory quality criteria, In such cases, @ ross-eference tothe tests dlscrbed inthe mandatory partis Beatie Panta ltd heroes on Te of a medicinal product by improving the consistency of the manufacturing proces and the performance of the medicinal product during use. Where control methods are cited, they are recognised as being suitable forthe purpose, but other methods an also be used. Wherever results fora particular characteristic are reported, the control method must be indicated, ‘The ollowing characteristics may be relevant for xanthan gum used a vscosty-increasng agent Viscosity (22.10): typically minimum 600 mPa-s, ‘Add 30 g (dred substance) within 45-90 s into 250 mL of a 12 W/L solution of potassium chloride Rin a 500 mL beaker stirring with @low-piteh propellertype stirrer rotating 4 800 r/min. When adding the substance take care that ‘agglomerates ace destroyed. Add an additional quantity of 44 ml of water R, to rinse any adhering residue from the ‘walls ofthe beaker. Stir the preparation at 600 x/min for 2h ‘whilst maintaining the tempprature at 24 = 1 °C. Determine the viscosity within 15 min & 24 #1 °C using a rotating General Roc apy tT ond ap i azzviscosimeter set a 60 min and equipped with a rotating spindle 178 mm high and 12.60 mam in diameter which is attached to shaft 3.2 mm in diameter. The distance from the top of the cylinder tothe lower tip ofthe shaft should be 25.60 mm aad the immersion depth 50.0 mm. ‘The following characteristics may be relevant for xanthan gars sused as matrix former in prolonged release tablets Viscosity: see test 2b Particle-size distibution (29.51 or 29.38) Powder flow (29.36) orp 9s981 XYLAZINE HYDROCHLORIDE FOR VETERINARY USE _ Xylazini hydrochloridum ad usum veterinarium M,2568 Test shution, Dissolve 0.100 4 ofthe substance tobe exarnined fn the solvent mizusre and dilate va 20.9 mi. ith the solvent mixtute. Reference solution (a). Dilute 1.0 sol. of the test sokation to 50.0 mol hth the solvent mixture. Dilute 1.0 ml. ofthis solution 19 10.0 mk. with the wolvent mixture. Reference season (b). Dissolve 5.0 mg of bupiraceine impurity P CRS (aylazine impsrity A) in acetonitrile Rat Aifute 12 100.0 ml. with the same solvent. efererce solution (), Dike 1.9 tak of refezence solution (2) to 100.0 ml. with the solvent mixture. Reference solution (4), Dibates snl, of the test sohation to 100 ml. with the solvent snipe, Mix 10 ml. ofthis solution with 10 mak of reference wlubion (b). Uilte tsa. of this ‘olution to 5 mL withthe solyent sixcure. Column: f ~ ste: 2015 m, 0 = 29 mim; = sationary phase: end-capped ect sea gel for ‘hromathpaphy wits polar \ncorporaied groups R (5 ya); = temperature: 49°C. Mobile phase: = mobile phase A: mix 0 volumes of riethandl RI and 70 volames of «2.72 pl solition of potassium dihydrogen ‘phoiphate R previously adjusted to pH 7.2 with dilate {odium hydroxide solution &; ~ mobile phase B: methanol RI, acetonit chromatograpy 2(30°70 V/V); le for Time Mabie pase A Mile pas in) zat ¥) exes os 9% i197 6-21 tm n iow rate: 1.0 mL/min. 4 Detection: spectrophotomet¢r at 230 asm. Anj : 20 pL of the test solution and tions (2) Ineo 2 pf ners ton ana elerence sions (0 Identification of impurities: use the obtained with reference ae solution (c) to dentify the peak due to Relative retention with reference to (retention time = about 8 min): impurity A 08. System suitably: reterence vlation (4): ‘reslation: minizum 4.0 between the peaks due to ‘Asad xylazine. [percentage contents: a oper A other than A, use the concentration of in reference solution (a). obs nrc 2th each impati,aximem jet cet, except for impiity A. 10 ppm. test A. Prepare the reference solution (1 ppm Pb) R. 5 per cent, determined for 2h. ‘cent, determinéd on ry rt