ARL Bio Pharma continues its association with Contract Laboratory – The Laboratory Outsourcing Network. With a commitment to quality, regulatory compliance, and scientific expertise, ARL Bio Pharma provides comprehensive pharmaceutical and microbiological testing services that support drug development, manufacturing, and quality assurance. Operating under FDA, DEA, and ISO/IEC 17025 accreditations, their laboratory meets the highest standards in the industry.
About ARL Bio Pharma
Founded with a focus on pharmaceutical quality and patient safety, ARL Bio Pharma has become a trusted partner for analytical testing, microbiological analysis, and regulatory compliance.
Their cGMP-compliant facility is equipped with advanced technology and a team of highly experienced scientists dedicated to delivering precise, reliable, and regulatory-compliant results. Specializing in drug formulation, stability testing, and sterility assurance, this laboratory ensures that every pharmaceutical product meets the highest safety and efficacy standards.
Comprehensive Testing Services Provided
1. Analytical Chemistry Testing
cGMP-compliant analytical chemistry testing to ensure pharmaceutical products meet regulatory requirements and quality specifications. Services include:
- Potency and Assay Testing: Quantitative analysis of active pharmaceutical ingredients (APIs) and drug formulations using HPLC, UPLC, and GC techniques.
- Impurities and Degradation Products: Identifying and quantifying related substances, residual solvents, and degradation byproducts per ICH Q3 guidelines.
- Dissolution Testing: Assessing drug release profiles using USP Apparatus 1 & 2 for bioavailability studies.
- Elemental Impurities Analysis: Detecting heavy metals using ICP-MS to comply with USP <232> and <233> standards.
- Water Content & Karl Fischer Analysis: Ensuring moisture content meets pharmaceutical stability requirements.
2. Microbiology Testing
Specialized microbiological testing to detect contaminants and verify sterility, ensuring patient safety and product integrity. Their USP <61>, <62>, <71>, and <85> compliant methods include:
- Sterility Testing: Using membrane filtration and direct inoculation per USP <71> to confirm the absence of viable microorganisms.
- Endotoxin Testing (LAL Test): Detection of bacterial endotoxins in injectable products, meeting USP <85> and FDA requirements.
- Microbial Enumeration & Pathogen Screening: Quantification of total aerobic microbial count (TAMC) and total yeast/mold count (TYMC) per USP <61> and <62>.
- Antimicrobial Effectiveness Testing (AET): Evaluating preservative efficacy in pharmaceutical formulations.
3. Stability Studies & Storage
ICH-compliant stability testing for drug products, ensuring shelf-life and formulation integrity under controlled conditions. Their stability services include:
- Accelerated & Long-Term Stability Testing: Conducted under ICH Q1A(R2) guidelines at multiple storage conditions.
- Forced Degradation Studies: Identifying potential degradation pathways for drug products to assess formulation robustness.
- Photostability Testing: Ensuring product stability under ICH Q1B light exposure conditions.
4. Sterile & Non-Sterile Compounding Testing
ARL Bio Pharma supports 503A and 503B compounding pharmacies with comprehensive testing for compounded formulations, including:
- Potency and Purity Testing: Verification of active ingredient concentration and absence of contaminants.
- USP <795> & <797> Compliance Testing: Ensuring compounded non-sterile and sterile preparations meet regulatory guidelines.
- Beyond-Use Dating (BUD) Studies: Determining the appropriate expiration period for compounded drug formulations.
5. Raw Material & Excipient Testing
cGMP-compliant raw material testing to verify the identity, purity, and quality of active pharmaceutical ingredients (APIs), excipients, and intermediates. Their USP/NF and EP-compliant services include:
- Identification & Purity Testing: Confirming raw material integrity via FTIR, NMR, and mass spectrometry.
- Residual Solvent Analysis: Compliance with USP <467> for organic volatile impurities.
- Microbial Limits Testing: Ensuring excipient safety by detecting microbiological contamination.
6. Container Closure Integrity Testing (CCIT)
Ensuring packaging integrity is crucial for maintaining product sterility. They offer USP <1207> CCIT using methods, such as helium leak detection, laser-based headspace analysis, and bubble and dye ingress testing.
7. Extractables & Leachables (E&L) Studies
Assessing the safety of pharmaceutical packaging and drug delivery systems using solvent extraction and Simulated-Use studies, GC-MS and LC-MS analysis of extractables, and USP <1663> and <1664> compliance.
Partner with ARL Bio Pharma
With their ISO/IEC 17025 accreditation, FDA and DEA compliance, and extensive expertise in pharmaceutical analysis, microbiology, and stability studies, ARL Bio Pharma is a valuable addition to the Contract Laboratory Network. Their modern facility, regulatory-driven approach, and commitment to delivering high-quality, cGMP-compliant testing make them a trusted partner for pharmaceutical manufacturers, contract development organizations (CDMOs), and compounding pharmacies.
By providing end-to-end analytical and microbiological testing services, ARL Bio Pharma helps clients maintain compliance, optimize drug formulations, and ensure patient safety. Outsource your testing needs to ARL Bio Pharma. Just submit a test request and rest easy!
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