medicines licensed in the UK, included in the Canadian List of ‘Acaeptable Non-medizinal Ingredients, 17. Related Substances Lactic Acid 18 Comments Generally, the commercially available product is a mixrare ‘water containing, 70-80% sodium lactate, The EINECS number for sodiunn lactate is 200-772.0. ‘The PubCheat Compound ID (CID) for soiamt lactate is 23666456, ich 19° Specific References 1 Suomela A, Keisoffecson Dry skin and moituaing agents. Ace Pharm Ben 1988, 822): 67-76 Sodium Lauryl Sulfate 1 Nonproprictary Names BP: Sodium Lauryl Sulphace JP: Sodio Lary! Sulfate PhE.r: Sodinm Laueilsulfate USP-NE: Soaiam Lauryl Sulfate 2 Synonyms Dodecyl alcoho! hydrogen sulfate, sodium sale; dodeey! sodivyn sollte; dodecylsulfate sodium salsy Elfar 240: lauryl sodium sulfate; lauryl sulfate, sodium salt; monadodecyl sodium sulfate; raw lusilullas; sagium dodecyl sulfa sodivm seladecsl sulfates soi laurilulfates sodim monodorecyl solace; sodian ‘monolauryl sulfate; SDS; SLS; sulfuric acid monododecyl estes, sodium salt; Texapon KIDP. 3 Chemical Name and CAS Registry Number Sulfuric acid monododecy! ester sodium sale (151) (151-21-3) 4 Empirical Formula and Molecular Weight ChatNaO,8 288.38 “The USP32-NT27 describes sodium awry] sulate asa mature of sodium alk! sulfates consisting chiefly of sodium lauryl sulfate {CHy(CH),oCHOSO5Na]. The PhEar 6.0 states that sodium Tauryl sulfate should contain not less than 85% of sodium alkyl sulfates calculated as Cy :NaO.S. 5. Structural Formula Sodium louryl Sulfate 651 2 Midewon Jb. Sodium lactate asa mostsier Ceemet Tiere 978 93/3} 45-86, 3. Lewis Rl, ed Sav’s Dangers Properties of dst! Mater, 1th sal New Yorks Wiley, 2004, 219722198, 20 General References 21 Author Hy de Jong, 22 Date of Revision 13 January 2008 6 Functional Category Anjouic surfactant; detergent; coulsfying. agents skin peneteant; ‘able and capsule lubricant veting agent. 7 Applications in Pharmaceutical Formulation or Technology Sodium lauryl sulfa isan anionic surfactant employed in a wide range of aonparenteral pharmaceutical formlasions and cosmetic, see Table, leis e detergent and wetting agent effective in both alkaline and acidie conditions, In reveur years it has found application i analytical eletrophoretic cechniques: SDS (sodium dodecyl slfate) polyacrylamide ge electrophoresis is one of the mare widely wed techniques forthe analysis of protsins!" and sodium lauryl sulfate thas been used to enhance the selectivity of micellar electrokinetic chromatography (MEKC).? Table t Uses Soi ry if ve Concentration 6) ‘Asionicendbifo, loos selemlafying base: wih 0:5-2.5 toy ecole Dalrgont in medicted shompoot 10 Shi deorserin opal appbcaions 7 Soldier incncatotins restr han cal >0.0025 Toblet beeen 10-20 ‘Weting eget in donor 19-20 8 Description Soulum lauryl sulfate consists of white or cream 10 pale yellow colored crystals, flakes, ar pawder having 4 smooth fech 3 #03py, Dior ease, and faint odor of faey substances 9 Pharmacopeial Specifications ‘See Table I. See also Section 18.652 Sodium Lauryl Sulfate ‘SEM: Exipient: sodium lou slat; manufocrer: Canadian Aoloc Lssmogaicaton: 120%" S18 2: Exner: sosiom lr slate; monafachner Canadian Alolae bs; maghifcaion: 600% “Table I: Phamacopeic oecfeations for sod Iau Bo Tet JP XV PhEur 40. USPSI-NF27 identccion : Ghorocters ? Abalinty : Heavy tals - 0.002% Sedu chlride ond vodum slate S8.0% Sodium Laury! Sullote 653 Jn the USP32-NE27, the General Chapter 5.9 in PhEur 6.0, along with the 'State of Works dacumene on the PhEue EDQM website, and also che General Information Chapree 8 in the JP XV. | specification for sod lary sullate is contained inthe Food ‘Cheroieals Codex (FOC). ‘The EINECS nasober for sodium lauryl slface is 205-788-1, The PaltChem Compound ID (CID) for sodium lauryl sullate is 3423265. 19° Specific References 1 Sih B.SDS polyacrylamide yl lestophoess of protin. Methods Mol Biol 1994, 32.33-34 2 Richkola ML at al Slesvy in capillary elecrophocesis i che presence of mises, chiral slecs. aad non-aqocous meds.) roman 1997, 79281 1338. 3. WiggerAecs W ot a Experimental irene contce derma deo cumulative epicutneous exposure to sodium lauyt sulphate and Toluene: single and concsteneappition. Br J Dermat 2000; 143 ‘sisi 4 Moricinans K ea. Salmosell mutagenicity tests eau fram the testing of 270 chemicals. Environ Magen 1985, 8Seppl 7-119 5 Blondel & er al Couact alley sa. 330 deraeoopical pacts Contac Devas 9h AS} 2-26, {6 Bruyn DP at al. Delayed tine course of irtaton by sd ur sult observations on thtesol eations. Comet Demat 1942; Sith 236-21, Exbanks SW, Patenon JW, Demat from sodia lay slate in Iyarcersone cream. Coma Dermatitis 1984 114) 250-25) 8 Grant WM. Toscolagyof te Eye nde. Sprnghil, IL: Chaskes C Thomas, 1974 964 9 Levis Red. See’ Dangerous Properties of lduaval Materia 11th sin, "New Yooks Wey, 20045 3258-8259, 10 Caldwal HC, Westlake W. Magnesian laut slae-stuble ub ine eter. Phar Sei 1972, 61, HLS, U1 Food Chemiedls Codes, 6th’ adn. Bethenla, MD: Unie Saves Pharnscopei, 2008, 895, 20 General Reforonces Pacopean Dicetorate for the Qualiy of Medicines and. Healtave (EDOM) Earopean Pharmacopoeia ~ Sate Of Work Ot lateratonal Haaiontation,Pharneuropr 2009) 21/1 182-143, hrpihwwed- smeaisteL tatu fccessed 3 February 2009) Macrae Ashton P. The eft ol sodium lave! sulfate on topal drug ‘bossa. Pharm Pbarmavol 1985; 27Supe. SP Nakagale M, Yokoyama 8, Acdcatljaed yet of sodium ogee! silat. J Phare Ses 1985, 74: 1947-1052. Vold KD, Mina KL. Determination of som ddsey alte in the eesence of nul aloha Cone 1972544 849-450, ‘Wan SC, Pons PRC. The interfacial acti of wa ay late nthe esence ofall. Cam J Pharm Sl 1970S: 1-107 ‘Wane LH, Chovehan 21 Drugcexcipene teractions retuhing from ovsder ising Ve role of sodium lr slat Tat J Phar 1990, 6 bis 21 Author P Plumb, 22 Date of Revision 3 Felbruary 2008.