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 Table386 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 —