Handheld Raman Spectrometer with 21CFR Part11 Compliance for Pharmaceutical Mateirals Identification

Raman spectroscopy addresses pharmaceutical quality needs through a single platform: non-destructive material ID, polymorph/hydrate analysis, continuous process verification, and anti-counterfeit fluorescence detection. These combined capabilities satisfy international pharmacopoeial standards requiring container-level authentication of starting materials. This multifunctional technique meets pharmaceutical compliance needs through,sealed-container material validation, polymorphic form analysis, continuous manufacturing control, fluorescence-based anti-counterfeiting, adherence to international standards requiring per-package starting material confirmation - all achieved through spectral fingerprint analysis.

Ensure material integrity from receiving dock to tablet press: JINSP RS1500DI's non-contact analysis minimizes cross-contamination risks while meeting stringent FDA data integrity standards. Includes spectral libraries for common pharmaceutical polymers and JNSP's validation protocols.

Product Specification:

• Rapid detection capability: completes identification within seconds.
• Non-invasive analysis: detects through various packaging materials including glass, woven bags, and plastics.
• Portable design: lightweight construction enables flexible movement across different work environments.
• Instant analysis: eliminates sample preparation requirements, ensuring safety and simplicity.
• Precision recognition: utilizes advanced machine learning algorithms for accurate identification with high specificity.

• Chemical raw materials: aspirin, folic acid, nicotinamide, etc.
• Pharmaceutical excipients: salts, alkalis, sugars, esters, alcohols, phenols, etc.
• Packaging materials: polyethylene, polypropylene, polycarbonate, ethylene-vinyl acetate copolymer, etc.

Compared with ordinary 785nm Raman, it has stronger detection ability

• Biochemical raw materials: amino acids and their derivatives, enzymes and coenzymes, proteins etc.
• Pigment excipients: carmine, carotene, curcuminchlorophyll, etc.
• Other polymer excipients: gelatin, microcrystalline cellulose, etc.

Company Introduction:

JINSP Company Limited, abbreviated as "JINSP", is a professional supplier with over 17 years of experience in spectral detection technology products, including Raman, FT-IR, LIBS technologies, etc. After 17 years of technology accumulation, the company’s core key technologies have reached the international leading position at the level, and the cumulative number of patent applications exceeded 200.

JINSP offers over twenty spectroscopic products across various fields, including pharmaceutical and chemical industries, public security, and customs. Products are available nationwide and are exported to over 30 countries, with cumulative sales exceeding 3,000 units.

Benefit from 30+ R&D engineers, including 4 Ph.D., JINSP is deeply rooted in the field of personalized product customization, and is committed to meeting the diverse and unique needs of customers with excellent professional technology and innovative design capabilities.