Dicloxacillin Sodium Compacted

Characteristics:
White hygroscopic, crystalline granules.

Application:
The substance is suitable for the manufacture of tablets and capsules. The appropriate excipients should be added.

Therapeutical category:
Oral, broad spectrum penicillin.

Pharmacopoeia quality:
USP, FEUM, Ph.Eur., BP & IP (latest editions).

Regulatory information:
Europe: Active Sustance Master File (ASMF) available

Packaging & shipping
Mexico/Latin America (MLA):
quantity per package: 25 kgs
approx. gross weight: 28.2 kgs
quantity per pallet: 300 kgs
approx. gross weight: 360 kgs

Inner package: a polyethylene bag inside a thermo sealed laminate bag.
Outer package: a corrugated cardboard box (25 kg);
box dimensions: l x w x h = 39 x 39 x 50 cm

Packaging & shipping
Asia Pacific/Middle East/Africa (AMEA) Drum:
quantity per package: 25 kg or 50 kg
approx. gross weight: 27.75 kg (for 25 kg)
approx. gross weight: 53.25 kg (for 50 kg)

Inner package: a polyethylene bag inside a thermo sealed laminate bag.
Outer package: a HDPE Drum

Packaging & shipping AMEA Box:
quantity per package: 25 kgs
approx. gross weight: 27.2 kgs (Compacted grade)
approx. gross weight: 28.5 kgs (Powder grade)

Inner package: a polyethylene bag inside a thermo sealed laminate  bag.
Outer package: a corrugated cardboard box (25 kg); box dimensions:
l x w x h = 380 x 380 x 600 cm (Powder grade)
l x w x h = 380 x 380 x 430 cm (Compacted grade)

Appearance:
White or almost white, hygroscopic, crystalline granules.

Assay (HPLC):
On anhydrous basis: 95.0 to 102.0%.

Absorbance at 430 nm:
≤ 0.04 AU.

pH (Ph.Eur.):
5.0 to 7.0

Water (Karl Fisher):
3.0 - 4.5

Dimethylaniline:
Absent (not used in manufacturing process).

Tapped density (USP II):
> 0.70 g/ml.

Shelf life / Retest date (as applicable):
3 years in the original packaging under 'storage conditions'.

Storage conditions:
Below 25°C protected from light and moisture.