Experience & Excellence
WELCOME TO ARL BIO PHARMA
Industries
![Pharmacy](/sites/default/files/2018-03/ico-1-b.png)
Pharmacy
ARL Bio Pharma provides analytical and microbiological testing for compounding pharmacies, outsourcing facilities, and health-system pharmacies. Our laboratory partners with industry suppliers bringing excellence to the compounding industry.
Services Offered:
- Potency Determination
- BUD and Stability Studies
- Sterility
- Endotoxin
- Fungal
- Microbial Identification
- Microbial Enumeration Tests
- Tests for Specified Organisms
- Antimicrobial Effectiveness Testing
- Particulate Matter by Light Obscuration
- Particulate Matter by Microscopy
![Raw Material](/sites/default/files/2018-03/ico-3-b.png)
Raw Material
ARL Bio Pharma qualifies drug substances, excipients, and drug products to meet pharmacopeia specifications.
Services Offered:
- Identification by IR
- Identification by UV
- Specific Gravity
- Water – Methods 1a, 1b, 2 and 3
- Residual Solvents
- Melting Point / Melting Range
- Loss on Drying
- Residue on Ignition
- Assay – HPLC, UV, Titration
- Heavy Metals
- pH
- Viscosity
- USP / NF (United States Pharmacopeia) testing
- EP (European Pharmacopeia) testing
- JP (Japanese Pharmacopeia) testing
![Pharmaceuticals](/sites/default/files/2018-03/ico-2-b.png)
Pharmaceuticals
ARL provides full laboratory services for pharmaceutical and biotechnology companies. Laboratory services include testing for New Drug Application (NDA), Abbreviated New Drug Application (ANDA), medical devices (510K) and over-the-counter products.
Services Offered:
- Stability Studies
- Compatibility Studies
- Raw Material Testing
- Dissolution Testing
- Microbial Identification
- Bioequivalence Studies
- Pre-clinical and Clinical Analytical Testing
![Forensics](/sites/default/files/2018-03/ico-4_0.png)
Forensics
ARL Bio Pharma provides comprehensive services to solve challenging drug investigations. These services are unique and specialized in pharmaceutical, toxicological, regulatory support, and research and development.
Services Offered:
- Chemical Analysis
- Biological Analysis
- Drug Diversion Testing
- Complaint Sample Testing
- Product Contamination
- Litigation Support
- Patent Infringement
- Literature Research and Review
![Leaf icon](/sites/default/files/2020-01/CBD_1.png)
Industrial Hemp and CBD
ARL Bio Pharma tests industrial hemp and cannabidiol (CBD) to meet industry quality specifications.
- Potency Testing
- Pesticides
- Heavy Metals
- Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms <62>
- Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests USP <61>
- Stability Studies
LATEST AROUND THE INDUSTRY
Bracketing's Application to Quality Testing
![](/sites/default/files/styles/news_im/public/2024-08/bracket.png?itok=s9iCKKW7)
Bracketing and its application to quality testing
Bracketing is a testing design approach recognized by USP, FDA, and ICH for assessing the quality of pharmaceutical products. It involves testing certain quality attributes at the lowest and highest extremes and assumes that intermediate levels are represented by the extreme test values. This design strategy reduces the samples needed for testing while ensuring product integrity.
Bracketing can be applied to compounded drug products with multiple strengths of identical or closely related formulations. Bracketing can also be applied to formulations of the same container closure system, where either container size or fill varies while the other remains constant. If both container size and fill vary, it's critical not to assume that the largest and smallest containers represent the extremes of all packaging configurations. Compounders must carefully select the extremes by comparing container closure system characteristics that may affect product stability.
Samples Amounts for Testing
![](/sites/default/files/styles/news_im/public/2024-07/Sampling-Size-Blue-2.jpg?itok=ycexMbIG)
It is important to send the appropriate sample size for testing in order to obtain accurate and reliable results. The required sample quantity may vary depending on the formulation and specific test performed. Additionally, when sending in samples for microbiology testing, it is crucial to take into account the batch size, as sampling quantities are determined based on statistical probabilities of identifying contamination across different articles and batch sizes.