Oxacilin Sodium Powder

Characteristics:
White or almost white powder.

Application:
The product is suitable for the manufacture of blends for suspensions, dry powder mixtures for syrups and tablets. The appropriate excipients should be added.

Therapeutical category:
Oral, broad spectrum penicillin.

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

Regulatory information:
Certification of Suitability of Monographs of the European Pharmacopoeia: available.

Packaging & shipping 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  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 powder.

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

Absorbance at 430 nm:
≤ 0.10 AU

pH (Ph.Eur.):
4.5 to 7.5

Water (Karl Fisher):
3.5 - 5.0%

Dimethylaniline:
Absent (not used in manufacturing process).

Tapped density (USP II):
≥ 0.28 g/ml.

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

Storage conditions:
Below 25ºC, protected from light and moisture.