Laboratorios Anderson provides analytical services for the pharmaceutical industry across the entire product lifecycle: from raw materials — APIs, excipients, and intermediates — to finished product — tablets, capsules, suspensions, solutions, syrups, and injectables. With GLP-OECD and ISO/IEC 17025 accreditation, results are defensible before regulatory authorities and technical dossiers.
Pharmaceutical Quality Control
Routine quality control verifies that each batch meets its specifications before release. It includes determinations such as:
- Loss on ignition
- Loss on drying
- Weight variation uniformity of dosage units
- Minimum content
- Volume variation
Dissolution Profile
Dissolution testing evaluates how and how quickly a solid product releases its active ingredient — a critical quality control parameter for tablets and capsules that supports both formulation development and batch release.
Research, Development, and Analytical Method Validation
Laboratorios Anderson supports development and technology transfer, and performs analytical method validation assessing parameters such as linearity, precision, accuracy, repeatability, reproducibility, robustness, specificity, limit of detection, and limit of quantitation. When a compound has no official method, the laboratory develops, optimizes, and validates one.
Available Quality Control Techniques
- pH
- Density
- Acid value
- UV-VIS quantification
- Chloride and sulfate limits
- Method implementation and validation
Deviation Investigation and Batch Release
Beyond routine testing, the laboratory supports deviation investigations and the batch release process, providing interpreted technical data that supports the decision on a product’s conformance before it reaches the market. In the United States, finished pharmaceutical testing and release fall under 21 CFR Part 211, the FDA’s current Good Manufacturing Practice (cGMP) regulations, which require validated methods for release testing under Section 211.165.
GLP-OECD and ISO/IEC 17025 Backed Results
Every analysis follows validated methodologies with complete documented traceability, making results defensible under regulatory audit and acceptable for pharmaceutical technical dossiers.
Request Your Pharmaceutical Testing
Whether for raw materials, finished product, new method validation, or batch release, we have the instrumentation and expertise to support your process. Contact us and request a quote for your pharmaceutical testing.
Frequently Asked Questions
What pharmaceutical testing does Laboratorios Anderson perform?
Testing for raw materials (APIs, excipients, intermediates) and finished product (tablets, capsules, suspensions, syrups, injectables), including quality control, method validation, dissolution studies, and batch release support.
What is analytical method validation?
It’s the process that confirms an analytical method is reliable, assessing parameters such as linearity, precision, accuracy, repeatability, reproducibility, and limits of detection and quantitation.
What does dissolution testing measure?
It measures how and how quickly a solid product releases its active ingredient, a critical parameter for tablets and capsules.
What accreditation backs Laboratorios Anderson’s pharmaceutical testing?
GLP-OECD and ISO/IEC 17025, ensuring documented traceability and results defensible under regulatory audit.
