Pharmaceutical Analysis and Testing Services
Pharmaceutical We Analyze
Identity, composition, impurity and material characterization for pharmaceutical raw materials, APIs, excipients, drug products and unknown substances.
Xinbodi Laboratories provides customized pharmaceutical analysis services according to the sample type and project objective. By combining chromatography, mass spectrometry, spectroscopy, elemental analysis and solid-state characterization, we help pharmaceutical companies and suppliers identify materials, compare batches, investigate impurities and understand product-related abnormalities.
APIs & Intermediates
Active pharmaceutical ingredients, API intermediates, Starting materials, Reference materials, Process-related byproducts, Degraded API samples, Unknown reaction products, Residual process materials
Excipients & Raw Materials
Fillers and binders, Disintegrants, Lubricants, Coating materials, Surfactants, Preservatives Stabilizers, Polymer excipients, Inorganic salts, Unknown excipient materials
Drug Products & Formulations
Tablets, Capsules, Powders and granules, Oral liquids, Suspensions, Creams and gels, Ointments, Injectable-related materials, Coated dosage forms, Complex formulations
Impurities, Particles & Packaging-Related Samples
Unknown impurities, Degradation products, Foreign particles, Precipitates, Discoloration residues, Filter deposits, Packaging fragments, Elastomer or polymer residues, Metallic particles
Common Pharmaceutical Analysis Needs
Identify pharmaceutical raw materials, APIs, excipients and unknown substances using complementary analytical methods.
Typical projects include:
- Compound identification
- API and excipient verification
- Major component analysis
- Organic and inorganic composition
- Functional-group identification
- Formulation component screening
- Unknown material identification
- Selected content determination where technically feasible
Investigate known and unknown substances that may originate from raw materials, synthesis, manufacturing, storage or degradation.
Typical targets include:
- Related substances
- Unknown chromatographic peaks
- Degradation products
- Process impurities
- Residual solvents
- Volatile contaminants
- Extractable organic substances
- Elemental impurities
- Unexpected organic or inorganic components
Characterize the physical and structural properties of APIs, excipients and solid pharmaceutical materials.
Projects may include:
- Polymorph comparison
- Crystalline-phase identification
- Hydrate or solvate investigation
- Amorphous versus crystalline comparison
- Thermal behavior
- Melting and transition characteristics
- Particle morphology
- Elemental distribution
- Material compatibility comparison
Compare pharmaceutical materials or products to identify meaningful differences between normal, abnormal or replacement samples.
Typical applications include:
- Supplier comparison
- Batch-to-batch comparison
- Original versus replacement raw material
- Normal versus abnormal product
- New versus aged sample
- Discoloration investigation
- Precipitation or crystallization
- Foreign-particle identification
- Packaging-related contamination
- Stability-related material changes
What Can Pharmaceutical Analysis Support?
- Raw material verification
- API and excipient identification
- Supplier qualification
- Batch consistency evaluation
- Unknown impurity investigation
- Residual solvent screening
- Elemental impurity analysis
- Polymorph and crystalline-form comparison
- Foreign-particle identification
- Degradation investigation
- Formulation comparison
- Quality complaint investigation
Methods for Pharmaceutical Analysis
Xinbodi selects analytical methods according to the sample matrix, target substance and required level of identification.
- HPLC / LC-MS / HRMS
APIs, non-volatile impurities, degradation products and unknown peaks. - GC / GC-MS / Headspace GC-MS
Residual solvents, volatile impurities and organic contaminants. - NMR
Molecular-structure confirmation and selected compound identification. - FTIR / Raman
Raw material identification, functional groups, polymorph comparison and foreign materials. - ICP-MS / ICP-OES
Elemental impurities, trace metals and inorganic contamination. - XRD
Crystalline phases, polymorphs, salts, hydrates and inorganic materials. - DSC / TGA
Thermal transitions, degradation, moisture-related changes and material comparison. - SEM-EDS
Foreign particles, morphology, coating layers and localized elemental composition.
What You Receive
Depending on the project scope, the report may include:
- Material or compound identification
- API or excipient verification
- Organic and inorganic composition
- Impurity and degradant information
- Residual solvent results
- Elemental impurity results
- Solid-state and crystalline-form comparison
- Supplier or batch comparison
- Foreign-particle identification
- Instrumental spectra and supporting data
- Interpretation of significant differences
- Recommendations for further verification
Standard projects: 5–10 working days
Rush service may be available depending on scope.
FAQs
Do you perform GMP testing or release testing?
We can support testing needs depending on your project requirements and documentation expectations. Share your intended use (R&D vs QC vs investigation) so we can align scope appropriately.
Can Xinbodi identify an unknown pharmaceutical impurity?
Often yes. LC-MS/HRMS is typically the first step; confirmation may require standards or NMR depending on complexity.
Can you support elemental impurities requirements?
Yes—method and limits depend on matrix and targets. ICP-MS is commonly used for trace metals screening.
Do you support polymorph or crystalline form investigations?
Yes. XRD/Raman (and thermal tools when needed) can help identify and compare solid-state forms.
How important is a reference sample?
Very. A known-good batch or standard makes comparisons faster and conclusions more defensible.
Is analysis destructive?
Some analyses can be destructive to the tested portion (e.g., sample prep, certain surface methods). We will clarify in the method plan.
Can APIs or excipients from two suppliers be compared?的标题
Yes. Samples can be compared for identity, composition, impurity profile, elemental composition, crystalline form and thermal characteristics.