Analytical Methods & Stability Study
RiboBio provides a full range of analytical testing services from nucleic acid product development to commercialization, using a variety of in vitro, in vivo, molecular biology, analytical chemistry and precision instrumental analysis methods to guide the design of testing programs and quality standards accepted by global regulatory agencies. Analytical method development, certification and verification covers:
(1) Raw materials
(2) Production process
(3) Standard parameter establishment for batch release
(4) Product release
(5) Drug stability”
● Packing Material Analysis and Verification
We develop analysis methods for product purity, related substances, water constituent, elemental impurities, sodium salts, residual solvents, contents, microbial limits, and bacterial endotoxin in different oligonucleotide products according to customer requirements, and verifiy these analytical methods to make them truly meet nucleotide and drug testing and quality control requirements. We also transfer these methods to customers based on pharmacopoeia requirements for further optimization and verification.
● Stability study of drugs
The study on the stability of oligonucleic acid APIs lays a foundation for designing appropriate formulation prescriptions and establishing stability measures, and is also an important part of pre-prescription research. Stability research is citical in deciding whether the drugs should be put into production for the market, and is also essetntial for the promortion and application of effective drugs with slight side effects.
With regard to the environment specifications during product use, packaging, storage and transportation, RiboPharm strictly follows the guidance of ICH Q1A (R2) stability of APIs and preparations and the 2015 edition of Chinese Pharmacopoeia (9001 Stability Testing Principle of APIs and Preparations) to provide customers with comprehensive stability research services.
● Conditional test, accelerated test and long-term test.
● Detection parameters: traits, content, total impurity.
● Accelerated stability tests: 6-month test in one specific environment
● Long-term stability tests: 36-month test in one specific environment.
● Mandatory investigation conditions include the effects on the decomposition, water constituent, single largest impurity, total impurity, content changes of samples under light, high temperature, high humidity, acid, alkali or oxidizing conditions.