In pharmaceutical QC labs, identity testing is crucial to ensure the final product is safe and effective. From incoming goods inspection to pharmacopeia-based verification and finished product testing, every result must be reproducible, traceable, and audit-ready under GMP. 

Anton Paar’s FTIR and Raman spectrometers support these workflows by providing rapid molecular identification and verification across different stages of the process. With AP Spectroscopy Suite, AP Connect, and qualification documentation, results are not only generated efficiently but also documented, reviewed, and transferred to meet regulatory expectations.

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Where FTIR and Raman spectrometers support pharma decisions

FTIR and Raman spectrometers provide complementary insights for verifying materials before they enter production, testing raw materials against pharmacopeial standards in QC laboratories, and confirming finished products before release.

Formulation development

Complementary FTIR and Raman fingerprints enable comparison of APIs and excipients, evaluation of candidate formulations, and stability monitoring.

Incoming goods inspection

Raman enables fast, non-destructive material checks in incoming QC – often directly through packaging – before materials enter production workflows.

Raw material verification in QC lab

FTIR supports standardized verification against approved references with repeatable sampling and method-defined acceptance criteria, aligned with QC procedures.
 

Finished product QC

FTIR can be used to verify finished product identity, perform confirmation testing, and support deviation investigations.
 

Data integrity and audit readiness

Versioned methods, role-based permissions, audit trails, and review workflows in AP Spectroscopy Suite support traceable, GMP-aligned QC processes and ensure audit readiness.
 

Ready to streamline your pharma spectroscopy workflows?

Learn how FTIR and Raman spectroscopy with compliant software can deliver paperless, audit-ready results across your QC processes.

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Vibrational Fingerprints for Pharmaceutical QC

The regulatory relevance of FTIR and Raman spectroscopy is reflected in pharmacopeial standards, recognizing both technologies for qualitative as well as quantitative characterization of pharmaceutical materials. USP 〈854, 1854〉, ChP 0402, Ph. Eur. 2.2.24, and JP 2.25 define infrared methods – referenced in over 1,300 monographs – while USP 〈858, 1858〉, ChP 0421, Ph. Eur. 2.2.48, and JP 2.26 define Raman methods.

Monitor displaying AP Spectroscopy Suite interface with Raman spectra graph and measurement details panel on white background

Faster incoming material release

Release or reject incoming materials with Raman before they enter the QC workflow.
Cora series probe-based Raman spectrometers measure spectra within seconds at goods receipt and compare them against approved references to deliver clear pass/fail results. Measurements can be performed through transparent packaging such as glass or certain plastics to avoid opening containers. This reduces handling and contamination risk, enabling fast material clearance and ensuring traceable results for subsequent QC verification.

Monitor displaying AP Spectroscopy Suite data explorer with analysis sessions list, verification results, and IR spectrum graph for paracetamol sample

Reproducible, pharmacopeia-aligned verification

Make release decisions in QC based on pharmacopeia-aligned identity testing with FTIR.
The Lyza series enables execution of predefined methods in the QC laboratory, combining measurement, processing, and spectral comparison in a single workflow. While routine samples are measured directly using ATR with minimal sample preparation, Lyza’s modular cell concept extends this approach to other sample types. Spectra are compared against approved libraries and match values are calculated automatically, delivering clear pass/fail results. This enables reliable identification and supports detection of deviations or foreign materials during routine QC testing.

Monitor displaying AP Spectroscopy Suite with quantification model overview, CBD mixture data, and calibration curve; Lyza 3000 referenced in interface

Reliable quantification for QC and process control

Determine concentrations to support QC decisions and process control. The Lyza and Cora series determine API concentrations in raw materials, intermediate mixtures, and finished dosage forms such as tablets or capsules. Quantification models are built from reference samples using linear calibration that correlates spectral features with API concentration and are integrated into both Lyza and Cora’s method workflows, combining spectral processing and peak evaluation for consistent QC results.

Anton Paar Spectroscopy Suite interface showing audit trail for Lyza 3000, with timestamped entries, status list, and detailed record panel

Audit-ready workflows with AP Spectroscopy Suite

Ensure that analytical results are generated, reviewed, and approved in line with 21 CFR Part 11, GAMP 5, and EU GMP Annex 11 requirements. An FTIR and Raman spectrometer setup with Lyza and Cora, operated using AP Spectroscopy Suite and method-based workflows, supports compliance with:

- Role-based access and restrictions (including Active Directory integration)
- Versioned methods and libraries
- Electronic signing and configurable review/approval workflows
- Audit trails with searchable records

Open ring binder labeled “AISQ+ Lyza 3000 or 7000 with Spectroscopy Suite” by Anton Paar, with ruler, pen, and calibration standards beside it

Reduce qualification effort and harmonize data transfer

Demonstrate that qualified systems and traceable data handling extend beyond the instrument workflow. AISQ+ documentation covering DQ/IQ/OQ/PQ ensures each system is fit for its intended use while reducing internal qualification effort in line with 21 CFR Part 11 and EU Annex 11.
AP Connect automatically transfers approved results to LIMS, ELN, or ERP systems, harmonizing interfaces to reduce manual transcription and support a secure, reviewable digital workflow.

Explore our Solutions for Compliant FTIR and Raman Spectroscopy

Pharmaceutical Instrument Qualification 

Application Reports and Technical Examples

Explore practical examples of FTIR and Raman applications in pharmaceutical and regulated environments.

Identity testing of raw materials using Lyza 7000

The Lyza 7000 FTIR Spectrometer, coupled with the pharma-compliant Anton Paar Spectroscopy Suite software, offers a precise and efficient solution for the analysis of raw materials, fully compliant with international pharmacopoeias. 

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Pharmacopoeia Conform Identification of Chenodeoxycholic Acid

Pharmacopoeial monographs set strict standards for the quality control of pharmaceutical compounds. 

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Quantification of an Active Pharmaceutical Ingredient in Excipient

Powders containing low analyte concentrations can be analyzed with Diffuse Reflectance Infrared Fourier Transform Spectroscopy (DRIFTS) with minimal sample preparation.

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Identity Testing of Raw Materials using Raman Spectroscopy

The Active Pharmaceutical Ingredients (APIs), the pharmacologically active part of a drug product, need to be tested among other things for their chemical identity as stated by international pharmacopeias and GMP guidelines.

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Distinguishing Between Different Crystal Modifications of Titanium Dioxide

Raman spectroscopy provides a unique chemical fingerprint of a substance. Not only the chemical composition, but also the structure within a crystal can be distinguished using the Raman technique.

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Identification of Essential Oils

Raman spectroscopy easily differentiates between different essential oils by their unique chemical fingerprint

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FTIR and Raman Spectrometers for Pharma Workflows

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Frequently Asked Questions

Q1: Do I need both FTIR and Raman?
Not always. Many pharmaceutical QC teams start with one technique based on their materials and SOPs. Because FTIR and Raman interact differently with samples and packaging, adding the second technique can reduce exceptions and strengthen coverage across receiving, QC, and investigations.

Q2: When should I use FTIR vs Raman for identity checks?
Both are established vibrational techniques for molecular identification. Selection typically depends on sample presentation, packaging, and handling constraints, and how the method is implemented in your GMP workflow. Many sites standardize both FTIR and Raman to keep identification consistent across different sampling realities.

Q3: How is identification typically performed?
Identity testing is commonly implemented through comparison with approved reference spectra stored in a controlled library. Acceptance criteria (e.g., correlation thresholds) are defined in advance and saved within a method. In AP Spectroscopy Suite, these methods can be executed in a guided workflow, providing clear verification results with predefined pass/fail evaluation.

Q4: Can FTIR and Raman spectrometer systems be operated from one workstation?
AP Spectroscopy Suite enables operation of Lyza FTIR and Cora Raman systems from a single PC environment. This supports standardized workflows, centralized method management, and consistent data handling across techniques.

Q5: What supports regulatory compliance?
Controlled user roles, electronic signatures, audit trails, and qualification documentation support alignment with GMP expectations, such as 21 CFR Part 11 / EU Annex 11 (see product details).

Q6: What does “compliant workflow” mean in practice?
In practice, a compliant workflow ensures that only authorized users can modify methods, that all changes are traceable, and that results undergo structured review and approval. It also means that data is securely stored and remains accessible and verifiable throughout its lifecycle.

Q7: What support is available for regulated implementation?
Anton Paar provides AISQ+ qualification documentation packages and structured support to align installation and operation with DQ, IQ, OQ, and PQ expectations. This helps laboratories reduce internal workload while preparing systems for regulated routine use.

Q8: How can results be transferred into LIMS/ELN?
AP Connect enables structured and automated data transfer between instruments and enterprise systems such as LIMS or ELN. Depending on configuration, integration options include file-based interfaces or REST API communication, eliminating manual transcription and improving data integrity.