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Oxacillin Sodium Compacted

Characteristics:
Granules obtained by means of dry compaction of the crystalline powder without adding any excipients.

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

Therapeutical category:
Oral, broad spectrum penicillin.

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

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 laminated 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 granules.

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):
≥ 0.80 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.


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