Services

Corresponding technical methods

• Extractables / Unknown Leachables Studies

• Known Leachables Studies

• Chemical Drug Structure Confirmation

1. （1）Conduct extraction testing on samples to collect extracts; （2）. Test extracts, divided into three fractions (volatiles, semi-volatiles, non-volatiles), with appropriate methods selected for each; （3）Calculate sample AET; method detection limits must be below AET; （4） Analyze test results, output substances above AET with semi-quantitative results; （5）risk assessment of semi-quantitative results

2. Methodology study + quantitative testing + toxicological risk assessment. (1) Perform extraction testing for target substances to obtain extracts; (2) Select appropriate scheme for analytical methodology study of target substances in samples; (3)Quantitatively test specified substances; （4） Conduct toxicological risk assessment of specified substances)

3. Known leachables analysis + chemical equivalence comparison (1. Perform identical analysis based on prior known leachables study data; 2. Use the same method as the competitor product to conduct known leachables analysis)

• Other

1. Customized according to specific project requirements

• In Vitro Degradation Testing 

Preparation of degradation media (commonly used: PBS, physiological saline); sampling at specified degradation conditions and time points; analysis of specified marker content in degradation fluids; plotting degradation curves; confirming whether sample degrades and degradation endpoint; analysis of final degradation products; verification of degradation mechanism

• Chemical Drug Testing

• TCM Testing

1. （1）Molecular weight series: MALDI-TOF, Q-TOF, HRMS, GPC or SEC-MALLS, etc.; （2） Particle size, single-crystal diffraction, XRD, 2D/3D Raman, etc.; （3）Essentially the same as tests for polymeric materials.

2. Same as other tests.

• Various Major Instrument Tests or Index-Specific Testing

Various major instruments

• RoHS Four/Six/Ten Items, REACH 2.0, Halogens, Heavy Metals, etc.

（1） Essentially the same as other testing; （2）Special note: standards are typically YY or Pharmacopoeia standards; （3） Such tests generally require CNAS accreditation, and some even GLP compliance.

• Chemical Drug Testing

• TCM Testing

1. （1）Essentially the same as other testing; （2） Special note: standards are typically YY or Pharmacopoeia standards; （3） Such tests generally require CNAS accreditation, and some even GLP compliance.

2. （1）Essentially the same as other testing; （2）Generally Pharmacopoeia standards are predominant; those not covered by Pharmacopoeia are rare.

• Compatibility Studies (Migration/Adsorption/Particulate Matter Evaluation)

（1）Composition analysis to confirm material composition; （2） Non-volatile residues in extracts; （3） Cytotoxicity testing; （4） Insoluble particulates; （5）Known leachables analysis; （6） Migration testing; （7）Adsorption testing

• Routine Three / Five Items 

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• Drug Qualitative & Quantitative Analysis and Release 

• Metal Ion Release

• Drug Adsorption 

1. Methodology validation + simulated release apparatus + HPLC/GC (1） Quantitative methodology for specified drugs; （2） Theoretical content; （3） Design and implementation of simulated drug release testing; （4）Release curve analysis).

2. Extraction testing (90 days) + methodology validation (1） Extraction testing with continuous renewal of extraction medium, generally over 90 days; （2） Elemental methodology).

3. Adsorption test apparatus + methodology validation (1） Quantitative methodology study; （2）Prepare post-use test samples per instructions for use, with blank controls; （3） Calculate adsorption rate based on blank and sample test results).