Canadian Pharmacies

ARL Bio Pharma provides analytical and microbiological testing for Canadian compounding pharmacies. 

Submit samples for testing through ARL's Client Portal. 

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Services Offered:

Stability Studies

A stability study measures the extent to which a product retains, within specified limits, and throughout its period of storage and use, the same properties and characteristics that it possessed at the time of compounding.

A study commonly includes: a stability indicating method assay, sterility (for sterile preparations), endotoxin (for most sterile preparations), pH, visual inspection, particulate matter, preservative effectiveness, preservative quantification, microbial limits (for non-sterile preparations), and the absence of specified organisms (for non-sterile preparations).

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Rapid Sterility

A rapid sterility test detects microbial contamination. This validated alternative sterility test method per USP <1223> is effective and reliable for 503A and 503B Facilities. Rapid test provides objective results in as little as six days.

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Fungal

This test is designed to increase the likelihood of detecting fungal microorganisms in sterile products. 

Microbial Identification

This test identifies microorganisms isolated during different phases of manufacturing and quality testing to the genus/species level using DNA sequencing.

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Antimicrobial Effectiveness Testing USP <51>

Particulate Matter USP <788>/<789>

A particulate matter tests for the presence of extraneous substances including: dust, glass, drug precipitates, rubber and other insoluble materials.

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Microbial Disinfectant Cleaning Challenge Studies

Microbial cleaning studies are essential to validating a facility’s cleaning SOP.  Pharmacies must demonstrate that cleaning agents, combined with instructions and procedures for their use, remove microbial contamination from surface areas where sterile drug products are compounded.

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USP <800> Surface Wipe Sampling Test

This test measures the level of hazardous drug surface residue to verify workplace safety.

Available drugs: Estriol, Estradiol, Estrone, Testosterone, Progesterone, Testosterone Propionate, Testosterone enanthate, Testosterone Cypionate, and Methotrexate

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