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Lactose, Anhydrous 1 Nonproprietary Names BP; Anhydrous lactose JP: Anhydrous lactose PhEur: Lactosum anhydricum, USPNF: Anhydrous lactose 2. Synonyms Anhydrous Lactose NF 60M; Anbydrous Lactose NF Direct Tableting, Lactopress Anhydrous, lactosum; lattioso;, mule sugar; Pharmatose DCL 21; Pharmatose DCL 22; saccharum Inetss Super Tab Anbydrous. 3. Chemical Name and CAS Registry Number 0-B.p-galactopyranosyl(1—4)-P-p-glucopyranose [63-42-3] 4 Empirical Formula and Molecular Weight CuHzOn 342.30 5. Structural Formula HoH On gH.0H on Anhydrous cactose ay : WO on on Anhydrous factose ‘The PhEur 2005 describes anhydrous lactose as O-ftD- galactopyranosyl-{1—4)-P-o-glucopyranose; or a mixture of (0 B-p-galactopyranosyl-{1—4)-2-b-glucopyranose and O-P-D- galactopyranosyl(1—4)-P-p-glucopyranose. The USPNF 23 ‘describes anhydrous lactose as being primarily [lactose of 3 mixture of a- and Brlactose. The JP 2001 describes anhydrous lactose as lactose or a mixture of lactose and aclactose 6 Functional Category Binding agent; directly compressible tableting excipients lyophilization aid; tablet and capsule filer. 7 Applications in Pharmaceutical Formulation fechnology Anhydrous lactose is widely used in direct compression tableting applications and as a tablet and capsule filler and binder, Anbydrous lactose can be used with moisture-sensitive drugs duc eo its low moisture content. See also Lactose, Monohydrate; Lactose, Spray-Dried. 8 Description Lactose occurs a8 white to off-white crystalline particles oF powder. Several different brands of anhydrous lactose are ‘commercially available which contain anhydrous factose and anhydrous aclactose. Anhydrous lactose typically contains 70-80% anhydrous Prlactose and 20-30% anhydrous 1 lactose. SEM: 1 Exeipient: Pharmatose DCL 21 ‘Manufacturers DSAV Ta Magnfieation: 200 Voltages LS4V 9 Pharmacopeial Specifications See Table 386 Lactose, Anhydrous SEM: 2 Escipionts Pharmatose DCL 22 Manfacturers DMV lernationsl Magnification: SSx Voltages LS WV) SEM: 3 Excipionts Super Tab Avbydrous Manufacturer: New Zealand Lactose Magnification: 500% Voltage: 16. 10. Typical Properties Angle of repose: 39° for Pharmatose DCL 21 and 38° for Super-Tab Anhydrous Brite fracture index: 0.0362 Bonding index: 0.0049 (ar compression pressure 177.8 MPa Density” (tue): 1.589 q/em" for anhydrous Pelactose 1.567 gem’ for Super-Tab Anhydrous Density (bulk): 0.68 em? for Pharmatose DCL 2 for Pharmutose DCL 22; 0.65 gem’ for Super rows Density” tapped): 0.88lem* for Pharmatose DCL 21; (0.79 glem for Pharmatose DCL 22; 0.87 gem? for Super Tab Anbydrous 0.67 glem? rab Anny Table k_Phormacopsial specications for lactose anhydrous Test JP 2001 PhEwr 2005 USPNF 23 ‘danifiaron + + + ‘Appearance color of + + ; ‘auton Characters - + - Optical rotation $SAdi 15440 35440 "55945594559 Acidity orally + + + Heavy metals =5ppm —

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