Quality of raw materials is an important part of the drug development and manufacturing process, which is directly related to the safety and efficacy of the final product. Testing raw materials aims to ensure that they meet their intended use, which is essential to preventing production delays and product quality problems.
Protheragen-ING Lab is a CGMP-compliant raw material testing laboratory that performs USP, EP, BP, ChP, JP and NF testing, committed to providing a complete range of pharmacopeia testing solutions for raw materials.
Our Services
Protheragen-ING Lab's pharmaceutical raw material testing services are a comprehensive set of solutions designed to ensure the quality and safety of raw materials and meet the high standards required by the pharmaceutical industry.
At Protheragen-ING Lab, we have a history of qualified USP raw material testing and we offer a full range of raw material testing services in compliance with GMP, USP and FDA guidelines. Our customers can receive accurate test results quickly and urgent test services can be provided as needed.
- Compendial Raw Material Testing Services
Protheragen-ING Lab has extensive experience in the testing of raw materials based on pharmacopeia methods and specifications. Our experts' first step in performing raw material testing is to validate the pharmacopoeia method to show that raw material samples can be tested repeatedly and precisely in accordance with the pharmacopoeia method. Our company's validation database contains all the raw materials that have been tested, which can be directly tested for samples, and can greatly reduce the test turnaround time.
- Non-compendial Raw Material Testing Services
For raw materials without pharmacopoeial methods, we will determine whether the existing pharmacopoeial method can be used for, or modified for non-compendial raw material testing. We can use our database to validate existing pharmacopeial methods for non-compendial raw materials to significantly reduce testing time. In the case this strategy is not available, our experts will be based on the customer's raw materials to develop and validate the new method.
Our Raw Materials Testing Services Scope
- Compendial Quality Control (QC) Raw Material Testing via USP, EP, JP, ChP, BP and FCC
- Elemental Impurities Analysis via ICP-MS
- Elemental Analysis (CHNSO)
- Thermogravimetric Analysis
- Differential Scanning Calorimetry Analysis
- Particle Size Analysis
- Heavy Metals, Arsenic, Lead, and Selenium Testing
- Metals by Atomic Absorption
- Residual Solvent Testing
- Water Testing by Kari Fischer
- Titrimetric Analysis
- Fourier Transform Infrared Detector (FTIR)
- Ultraviolet / Visible (UV/VIS) Spectroscopy
- Container Testing - USP <661> and USP <671>
- Endotoxin Testing (Both Sterile and Non-Sterile Products)
- Microbial Enumeration Test
- Absence of Specified Organisms
- Sterility
In the pharmaceutical industry, strict monitoring and control of raw materials is a key step to ensuring the quality of drugs. Identification, purity and quality verification of raw materials are not only required by the FDA, but also help customers to determine the origin of their raw materials and the eligibility of their suppliers. Protheragen-ING Lab's Pharmaceutical Raw Material Monitoring Service is designed to meet the needs of our customers.
Contact us today to learn more about our raw materials testing services or to inquire about customized testing solutions.