Over 20 years of experience in R&D

01 Drug Discovery

Chemistry Research

Biology Research

Early Pharmacokinetics

02 Pharmaceutical Research

Intermediates

Active Pharmaceutical Ingredients

Pharmaceutical preparation

Analytical Method Development and Quality Control

CMC Filings

Analytical Testing Center

03 Preclinical Research

Pharmacology & Pharmacodynamics

Drug Safety Evaluation

DMPK

Bioanalysis

IND Filings

01 One-stop Integrated Services

Liposome Drug Development

Drug Discovery

Pharmaceutical Research

Preclinical Research

Botanical Drug Preclinical R&D

02 Innovative Drug Services

ADC

PROTAC

mRNA Vaccine

Cellular Immunotherapies

Nucleic Acid Drug

Peptide Drug Conjugate (PDC)

Antibody

03 Key Technical Services for Drug R&D

Cytokine and Biomarker Detection

Metabolite Identification (MetID)

Drug Forming Research

Flow Cytometry Technology

SEND Format Conversion

Flow Sorting

NanoString nCounter Detection

Routes of Drug Administration

04 Drug Efficacy Evaluation for Common Diseases

IO Pharmacodynamic Model

Inflammatory and Immune Diseases

Rodent Cerebrovascular Disease

05 Advanced Preparation R&D

Inhalation drug

Ophthalmic drug

Skin Topical Preparation

06 Targeted Drugs R&D Services

STAT3-targeted Drugs R&D Service

GLP-1 New Drug R&D Service

KRAS-targeted Drugs R&D Service

2024-07-22Medicilon Events

The Shanghai Overseas Returned Scholars Association invites the Dutch PhD delegation to visit Medicilon, exploring paths for innovative development together

On July 4th, the Shanghai Overseas Returned Scholars Association invited the Dutch PhD delegation to visit the Chuansha campus of Shanghai Medicilon Inc. (Medicilon) and held discussions with Medicilon's Founder and CEO, Chunlin Chen, among others.

Learn more

2024-07-22Medicilon Events

5th consecutive win! Medicilon once again made the list of "Top 20 Chinese R&D CRO Enterprises in 2024"

Medicilon stood out among hundreds of pharmaceutical enterprises and was honored with the "Top 20 Chinese R&D CRO Enterprises in 2024" award.

Medicilon 688202

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Address: 20 Maguire Road, Suite 103, Lexington, MA 02421(America)

Tel: +1(626)986-9880

Address: Allia Future Business Centre Kings Hedges Road Cambridge CB4 2HY, UK

Tel: 0044 7790 816 954

Email: marketing@medicilon.com

China

Address: No.585 Chuanda Road, Pudong New Area, Shanghai (Headquarters)

Postcode: 201299

Tel: +86 (21) 5859-1500 (main line)

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Pharmaceutical Research

FAQs

HomeservicesPharmaceutical ResearchPharmaceutical preparationFormulation Stability Study

Formulation Stability Study

Research on the stability of pharmaceutical preparations provides a scientific basis for the determination of production, packaging, storage, transportation conditions and the validity period of pharmaceutical products. This is achieved by investigating the parameters of the changes of API properties and preparations with time under the influence of temperature, humidity and light, so as to ensure the safety and effectiveness of clinical medication. Stability evaluation is one of the main components of drug quality control research. It is closely related to drug quality research and the establishment of quality standards.

The research on preparation stability is featured by phases and links all steps in drug R&D.
Different placement conditions for stability study based on different formsDifferent investigation items based on different formsDifferent packaging materials based on different formsInvestigation of physicochemical properties and stability of drugs Scheme design of stability study, project management, storage and detection of samples for stability study, data trend analysis, and evaluation of drug shelf life
Content of stability study
Stability of global drug registration; experimental/exploratory stability (pre-experiment); and stability of drugs after approval for marketComprehensive services such as scheme design, project management, stability sample storage and testing, data trend analysis, drug shelf-life evaluation and NDA/MAA filing document preparationStorage: 40°C/75%RH, 30°C/75%RH, 30°C/65%RH, 25°C/60%RH, with proper lighting, or the storage conditions specified by the customer, including 2-8°C, -20°C, -70°C, 25/40, 30/35, 40/20 and 50/40 (new)Qualified constant temperature and humidity box (IQ/OQ/PQ certified) for stability study; multi-channel power supply; Real-time temperature and humidity monitoring (dual system); and automatic alarm system;Three batches (filing batches) of pilot-scale stability test Investigation of influence factors with packages of one batch of samples removedInvestigation of influence factors during production with packages of one batch of samples retained for potential analysisAcceleration test of three batches of samplesIntermediate condition test of three batches of samplesLong-term test of three batches of samples

FAQ

What is Stability of a Drug?

The stability of a drug refers to the degree to which the physical, chemical, biological and microbial properties of an active substance or formulation can be maintained within prescribed limits during its entire storage and use.

Relevant laboratories

Relevant articles

Consistency Evaluation Preformulation Study Formulation Stability Study GMP-based Clinical Sample Production & Packaging Pilot-scale Preparation Testing Laboratory-scale Preparation Testing