ICPMS
Další informace
WebinářeO násKontaktujte násPodmínky užití
LabRulez s.r.o. Všechna práva vyhrazena. Obsah dostupný pod licencí CC BY-SA 4.0 Uveďte původ-Zachovejte licenci.

NanoRam-1064 Fast Facts: Botanical Verification

Aplikace |  | MetrohmInstrumentace
RAMAN Spektrometrie
Zaměření
Farmaceutická analýza
Výrobce
Metrohm

Souhrn

Significance of the Topic


Botanical extracts are widely used in dietary supplements and nutraceuticals for their therapeutic properties. Ensuring the authenticity and purity of these materials is critical to meet regulatory standards and protect consumer safety. Raman spectroscopy offers a rapid, nondestructive approach to identify plant-derived compounds, but traditional handheld systems can struggle with fluorescence interference from colored samples.

Study Objectives and Overview


This application note evaluates the performance of a handheld Raman spectrometer operating at 1064 nm for verifying four botanical extracts: vitamin K2, pomegranate, rhodiola rosea and grape seed. The goals were to demonstrate fluorescence minimization, validate a robust identification algorithm and confirm method specificity across multiple plant materials.

Used Instrumentation


  • NanoRam®-1064 Handheld Raman Spectrometer (BWT-840000953)
  • Point-and-shoot sampling adapter

Methodology and Instrumentation


The NanoRam-1064 device, compliant with major pharmacopeias and FDA 21 CFR Part 11, was used to collect spectra through sealed plastic bags. Laser power was adjusted to 90 % (~380 mW) for the light-colored vitamin K2 and 10 % (~42 mW) for the darker pomegranate, rhodiola rosea and grape seed extracts. For each botanical, five spectra were acquired at different spots to build individual identification methods based on a multivariate algorithm. All samples were then tested against each method to assess true positives and false positives.

Main Results and Discussion


The 1064 nm excitation significantly reduced fluorescence in dark plant samples, allowing clear detection of characteristic Raman peaks. Method specificity was evaluated via p-values: values above 0.05 indicated a pass, while those below 0.05 indicated a fail. Each botanical method correctly passed its target extract and rejected the other three, demonstrating high selectivity and reliability.

Benefits and Practical Applications


  • Rapid, on-site verification of incoming raw materials without sample preparation.
  • Ability to analyze colored extracts with minimal fluorescence interference.
  • Compliance with USP <858>, EP 2.2.48, JP 2.26 and Chinese Pharmacopeia directives.
  • Full audit-trail software meeting 21 CFR Part 11 requirements.

Future Trends and Opportunities


Adoption of 1064 nm Raman devices is likely to grow in pharmaceutical and nutraceutical quality control labs. Advances in multivariate algorithms, expanded spectral libraries and integration with manufacturing execution systems will further streamline raw material verification. Emerging applications include in-process monitoring and mobile field analysis.

Conclusion


The NanoRam-1064 handheld Raman spectrometer offers a robust solution for botanical verification, effectively minimizing fluorescence and delivering accurate, specific identification for a range of plant extracts. Its compliance with global pharmacopeial standards and ease of use make it a valuable tool for cGMP environments.

References


  • Metrohm AG. NanoRam®-1064 Fast Facts: Botanical Verification. Application Note 6410000049.
  • United States Pharmacopeia <858> Raman Spectroscopy.
  • European Pharmacopeia 2.2.48 Raman Spectroscopy.
  • Japanese Pharmacopeia 2.26 Raman Spectroscopy.
  • People’s Republic of China Pharmacopeia Directives on Raman Spectroscopy.
  • PIC/S & GMP Guidelines on 100% identity assurance for starting materials.
  • FDA 21 CFR Part 11 and Part 1040.10 compliance requirements.

Obsah byl automaticky vytvořen z originálního PDF dokumentu pomocí AI a může obsahovat nepřesnosti.

PDF verze ke stažení a čtení
 

Podobná PDF

Toggle
NanoRam® -1064 Fast Facts: Raw Material Verification of Cellulose and its Derivatives
For more information, please contact us at +1 (302) 368-7824 NanoRam®-1064 Fast Facts: Raw Material Verification of Cellulose and its Derivatives Introduction: Cellulose is a naturally-derived, highly common raw material found within the pharmaceutical world, providing the underlying foundation for…
Klíčová slova
cellulose, cellulosederivatives, derivativesmayle, maylefrano, franofluorescence, fluorescencekristen, kristenvanessa, vanessaits, itsfive, fiveprevalence, prevalenceexcipient, excipientfails, failsunderlying, underlyingmaterial, materialvalidity
Transition RMID Operations Between Handheld Raman Devices
Application Note AN-RS-045 Transition RMID Operations Between Handheld Raman Devices Library and Model Transfer from NanoRam 785 to MIRA P For lab-quality results in non-traditional testing validated verification models already in routine use scenarios such as materials inspection at the…
Klíčová slova
mira, mirarmid, rmidverification, verificationmodel, modelpackage, packageraman, ramancsv, csvbasic, basicnid, nidnanoram, nanoramidentification, identificationtransfer, transferlibrary, librarytek, tekvalidation
Metrohm NanoRam-1064 handheld Raman spectrometer
Metrohm NanoRam-1064 handheld Raman spectrometer
2021|Metrohm|Brožury a specifikace
NanoRam®-1064 The NanoRam-1064 is a state-of-the-art handheld Raman instrument for nondestructive identification and verification of incoming raw materials such as APIs, excipients, and intermediates. Compact and agile, the NanoRam-1064 can be used by non-technical users to rapidly identify samples in…
Klíčová slova
adaptor, adaptorbarcode, barcodedata, datasecure, secureeasy, easysoftware, softwarenid, nidmultiple, multipleaccessories, accessorieshanded, handedadaptors, adaptorsoptional, optionalbrightness, brightnessquick, quicklanguages
Verification of Nutraceutical Raw Ingredients Directly Through Packaging
Application Note Pharma and Biopharma Verification of Nutraceutical Raw Ingredients Directly Through Packaging Simple, fast, and accurate identification using Agilent Vaya handheld Raman spectrometer Author Christopher Welsby Agilent Technologies, Inc. Abstract This study explores how the Agilent Vaya Raman handheld…
Klíčová slova
vaya, vayaraman, ramancontainers, containersnontransparent, nontransparentraw, rawnutraceuticals, nutraceuticalsvitamin, vitaminhandheld, handheldglucosamine, glucosaminebotanicals, botanicalssors, sorsverification, verificationingredients, ingredientstesting, testingthrough
Další projekty
GCMS
LCMS
Sledujte nás
Další informace
WebinářeO násKontaktujte násPodmínky užití
LabRulez s.r.o. Všechna práva vyhrazena. Obsah dostupný pod licencí CC BY-SA 4.0 Uveďte původ-Zachovejte licenci.