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Lactose Anhydrous

1] Description: White or almost white, powder or free flowing powder.

Note: Browning of the product occurs when combined with amines (Kosky, K.T. et. al., Hammouda, Y. and Salakawy, S.A., and Severine, T. and Loidl, A.).

2] Physical Characteristics:

Water Content: NMT 1.0%

LOD: NMT 0.5%

Typical Properties	Pharmatose® DCL 21*	Sheffield DT	Sheffield 60M
Typical Bulk Density (g/cc)	0.63	--	--
Particle Size Specification	NMT 20% < 45 microns 40 - 65% < 150 microns NLT 80% < 250 microns	10-20% = 60 mesh 15-30% = 80 mesh 7-15% = 100 mesh 6-20% = 200 mesh 20-30% thru 200 mesh	0-5% = 60 mesh 10-30% = 80 mesh 7-20% = 100 mesh 10-25% = 200mesh 10-40% thru 200 mesh

* Measured by mechanical sieve shaker

3] Applications:

Wet granulation filler/binder

Direct compression filler/binder

4] Suppliers:

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5] References:

Kosky, K.T., Duvall, R.N., Troup, A.E., Pyles, J.W. (1965) Factors involved in the

Browning of Spray-dried Lactose, J Pharm Sci, 54:4, 549-554.

Hammouda, Y. and Salakawy, S.A., (1971) Non-enzymatic Browning in

Solid-dosage Forms: Lactose-induced Discoloration of Neomycin Tablets,

Pharmazie, 26:10, 636-640.

Severine, T. and Loidl, A. (1976) Formation of Pyridone Derivates from Maltose

and Lactose. XII. Investigations on the Maillard-reaction, Z Lebensm Unters

Forsch, 161:2, 119-124.

Pharmatoseâ DCL 21, Lactose Anhydrous NF – Product Bulletin rev. 4/99, CHR Hansen

Sheffield™ Brand Anhydrous Lactose NF, Product Information, 2002

Pformulate/lactoanhyd/09/14/2002 updated 08/15/2004