SpecinicaTiON. a WOCTTOCPT Specification rersor | 05 Specification | “swysonreoe_| wesramaatcremcnt mous Teese | agnor0 |'St | ocober2 15/1, eso Ron Lake Town, Kelkata 700089, West Bengal nda. | SUPES®HES on [pasee_ | tet TINISHED MATERIAL NAME SODIUM BUTYRATE Chemical Formulas CHiCHGNCOONG | CASH 156-547 Molecular Weight 11008em/m0l ecw 205.0576 Intemal Code No. SOBFE98 Pharmacopocial/Non-Pharmacopocial eference: iS Sk. PARAMETER SPECFICATION ‘White ee Tova power, with canal abe lamp, 2, _| eseeton dour character 2._|Soiwbity lube inwoter 3._[ identification Paste for Sodium & Bute Ae al 4. [pilaf 30% solution water 70-110 5. | Heavy Meta (a eas) N20 ppm = «| arenie MTS pom 7 | LOD (ati05°Ctil constant weight) _| NNT 30% w/w | Assay (On Dried Bass) 58.05 win 101.0% who + History of change: = ‘Version No, | fective Oate Reason for change a a/ans Speciation (Change cont WBCL/CEOR/A6.7) oe mipione ein of Speateation. | 29/00 No change incontent, Review done os preview due reparedby ‘Checked by Teproved by Department Trodion ac Cy Sianature & Kw f boo ation | Ten fe | Banca ester ba wig dv Sai) EXucie ~ fle Pratulos SO [one] 29 /10f22 a9/fofae 23 ref PY UNCONTROLLED COPY'STANDARO TESTING PROCEDURE a WECITOCETA| stow [BCU [version | 05 wesraenat cuetacaLiNousrresunaeo | Eectve Revson | Oaber 25/10/20 1/1, estore Road, take Town, | date 10/20 | date 2 Kothata-700000, West Bengal india. | Sparaader | 04 | Faget | tof TITLE SODIUR BUTYRATE 2) Desrition: White ree lowing powder, wth occasional abe lump, odour characters 2) Solubility Take abaut:.0 gm of the sample and add 30.0m of water. Thereby, mbit wel Limit: Solubie in water 3) Idontietion: 1+ Sodium: Take about lg of Sodium butyrate and dissolve it in 20m of water. Ate ha, ‘add 20m! of 15.0% Potassium carbonate, and heat to bol the solution. Ceol to room temperate. No precipitate f formed. Add 4.0ml of Potassium pyreantimenate TS, and heat to bol the mixture, Allow 0 coo in ice water, and if necessary, eb the side of the test tube with glass rod. A dense precipitate is formed. Sodium compourd imparts 2n Intence yellow colour toa nonlminods flame, 1 Butyrie Rei: Take about 0.2gm of Solum butyrate and dsslve it in 2.0m) of water, Ads 120. of H:80s, and heat to boll the solution. After that, cool the soluion to room temperature. The sell the gasisBuyric Ad Limit: Positive for Scium and Butyric Ae 4) Ht (of 10% solution In water} Take 10.05m of the sample ad ad 100.0r of water tot, Mic the sample soltion well, Determine the pH of the solution Using calbrated pH meter Limits? 0-210 5) Loss on Oryng (at 105°C til constant weight}: Take about 1.0 gm ofthe sample na clean an ‘red pete ish and keep it ina hot air oven at 10SEC tl constant weight After tat, Keep the petri din a desiccator to col at roam temperature and thereby weigh it Calculation Weight Loss ofthe sample x 100 Welght of sample before dring Limit: MT 3.0% w/e 8) Arsen + Preparation of Arsenic Standard Solution (2000ppm As): lsat 0.30 f sere triode In S0ntof2() Sodium hydroxide and dst to25D0 mwah wate. ‘+ Preparation of Arsenic Standard Sokstion (3ppm As): Diute 03 volune of Arsenic Standard Solution {10005em of Bs 1 100 voles with water ‘Standard Preparation: Pipette out 3.0m of Standard Arsarie Solution (3pm) into an Arsenic apparatus, and lute with 35.0ml of ater Prepared by Checked by Repoved by Designation Broce aC Becutve Ge Erecave GA ‘Signature | 7 B _ Bie ghee aie] ef M ¢ CO UNCONTROLLED COPY‘STANDARD TESTING PROCEDURE _ WeCLRE 6 sree | soars e wereenca.cxtmenmousnes une | Eecie Tes | Beer "spon Tailor on sks Town | te tia rota 70008, west ena [Sgesles [we — [age] 2 "te Soo BUTTE + Test Preparation: Take about Sgm ofthe sample and lute wth 35.0ml of water. ‘+ Procedure: 1reatthe standard Preparation and the Test Preparation simi astollows Into the arsenic apparatus the test soliton and the standard solution ls introduced Indvldally, £4 10.0ml of concentrate Hydrochloric Ad, 100g of Zine AST and 5.0 ml of 1UM) Potassium lodide and immediately assemble the apparatus. After 40min any sain produced on the Mercure Chloride paper not more intense than that obtained by treating Inthe same manser for Arsenic Sadar Soliton Umit: IMT3.0ppm. 7) Heavy Metals (os Lend) 1+ Preparation of Lead Standard Solution (1000ppm of Pb}: Dissolve 0.400 gm ef ea trate Inwater containing 2.0ml of tread and ad sufficient water to produce 2500 mi + Preparation of Lead Standard Solution (10 ppm of PB): Dilute 1 volume of exe standard ‘solution (1000p6m of Pb) to 100 volumes wth ater, + Standard Preparation: Take 2.0m of Pb Standard (10ppm) into a clean 100.0n! of Nese Cylinder and volume make upto 25.0ml with water. Maletaln the pit of the solution between 3.0 to 4.0 using 1(N) Acetic acl & GIN} Ammonium hydroxide. Dilute wth water to 0.0m and mix propery ‘+ Sample Preparation: Take about 2.0gm ofthe sample nto a dean 100.0ml Neer Cylinder {add 250ml of water. Maltin the pit ofthe solution between 3.0t0 4.0 using 1H) acetic ¢id& GN} Ammonium hydroxide. Olute with water to 400m and mix prope + Procedure: To each of the two 1000! of clean Nessler Cylinder (Standard & Sample Preparation), add 2ml of pH 3. Acetate buffer and 1.2m) of Tioacetamide reagent and volume make up to 50.0mi with water. low it to stand for 2 minutes & view downward ‘vera white surface The colour ofthe solution obtained from the Sample Preparation fs not more darker than that ofthe solution obtained from the Standard Preparation, Umit: WMT 100 ppm. £8) Assay (On Dried Bass: Take 3 clean & cry conic fask Pour Som of acetal. M4 hops ‘of eraphthol benzene. Neuve with 23 dap of Percloric acd, Dissolve aout 300g Freparedby Checked by ‘Approved by Designation iaecuive Breve G6 Tse GA Signature | -p 8 Pdr Date wy 2ofre]ae Wl ae ASTER UNCONTROLLED COPYSTANDARD TESTING PROCEDURE. = ca sien | MMSE ercn |e a rr——C“#ERE filer foesske Tw | te te |e xohera 10008 wet aenaimia._ [es | bare BF Te: SODHN BUTERTE ofthe sample in above neutralized 50m of gladal acetic acid, Heat the solution & then cool to oom temperature, After tat, titrate the son, with ON) Perchlvic acto a green endpoint Eachml of 4(N)Perchlorc ace equivalent to 0.01401gm of CHsCHsCHsCOONS Caleuation: ‘+ Assay (On Asis Bass Volume of 0.11N)Perchorc acid consumed X Factor of 11M) Perchorc acid X0.01101 X 100, ‘ght ofthe Sample takenin gm ‘+ Assay (On Dred 835) Assay on a i bass X00 {400 -L00) Limit: 98.0% w/w ~ 101.0% wh (OnDried Basi) + History of change ‘Version No. | Effective Date. ‘Reason for change TDiif6 | “faker change ange conve, WSCC TD I noha evi of SP 25/10/20 —| —wochange none Revow done 3 per ae ie Preparedby Gheckedby Aowrovedby Desgaaton | Enero OC 5 Becatve OC Exeive OR x Aw | dos Date Dye aeofao | aru “ UNCONTROLLED COPY