LVA Pharma

von LVA Pharma und EL spol. s r.o.

  • GMP certification and EMA FDA inspected
  • for API, Excipients, Finished Pharmaceutical Products

Gemeinsam mit unseren internationalen Kooperationspartnern bieten wir unseren Kunden fundiertes Know How und können auch in dieser Branche mit zahlreichen Dienstleistungen unterstützen.

Im Portfolio bieten wir ein breites Spektrum an analytischen Dienstleistungen für Rohstoffe, Wirkstoffe, Zwischenprodukte, Fertigprodukte, Behältnisse, Umwelt und vieles mehr.

Diese Verfahren entsprechen den wichtigsten Pharmakopöen EP, USP (BP, JP).

Auf Kundenwunsch können wir auch Methodenentwicklung und -validierung oder -verifizierung sowie einen Methodentransfer vom Ursprungslabor durchführen.

Wir sind ein GMP zertifiziertes Labor und die Analysen werden unter anerkannter Qualitätssicherungsstandards durchgeführt, Analysezertifikate von unserer Qualified Person (QP) geprüft und ausgestellt.

Details zu unseren Prüfungsumfängen finden sie nachstehend.

 

We provide a wide range of analytical services covering raw materials, APIs, intermediates, finished products, containers, environment and much more, according the most relevant Pharmacopoeia EP, USP (BP, JP) with best practise and performance. We also perform method development & validation or verification and if desired a method transfer from the originator laboratory. We perform all analysis under approved Quality Assurance and the Analytical Certificates are proofed & issued by our QP and GMP certified.

 

Quality Control

for API, Excipients, Finished Pharmaceutical Products, Small Molecules

Physico Chemical Testing
  • General identification test (IR, TLC, HPLC,UV-VIS)
  • Assay (UV/Vis, AAS, titration, HPLC with multiple detectors, UPLC, GC, GC/MS, LC/MS) and dosage uniformity
  • Related substances identification and quantification (GC, HPLC, GC/MS, LC/MS)
  • Physical determinations (pH, viscosity, density, polarimetry, refraction index, melting point, osmolality)
  • Moisture (Karl Fisher, loss on drying)
  • Limit tests (heavy metals, ash, anions)
  • Residual solvents (volatile organic compounds, organic volatile impurities)
  • Elemental impurities (AAS, ICP/MS,AES-ICP)
  • Solid oral dosage tests (disintegration, dissolution, hardness, friability)
  • Particulate matter (visible and sub-visible particles)
  • Process environment analysis (cross-contamination, rinse water from cleaning process, swabbing surfaces)
  • Analysis of orally inhaled and nasal drug products (OINDP)
 
Microbiological Testing
  • Microbial counting: TAMC, TYMC
  • Determination of pathogens
  • Sterility testing
  • Bacterial Endotoxins
  • Water analysis

 

Batch and Batch Release
  • EU-Import & QP Service for medicinal products (human, veterinary, etc.)
  • Final batch release testing & certification according Pharmacopeia and product related
  • EU QP release
  • QP declaration
  • Preparation / revision of batch records & SOPs

 

Elemental Impurities

according to the ICH Q3D, USP and Ph.Eur. 5.20 and 2.4.20 Guidelines with ICP-MS and ICP-AES/OES in the following matrices:

  • APIs
  • Formulation excipients
  • Water
  • Intermediates and finished products
  • Pharmaceuticals

 

Dissolution Rate Testing

accordance with Ph. Eur. 2.9.3 and USP harmonized in ICH Q4B Annex 7R2 as well as Ph. Eur. 2.9.42, Ph. Eur. 2.9.43 and USP monitoring according to needs by LC, UPLC, as well as spectrophotometer

 
Amino Acid Analysis

according to Ph. Eur. 2.2.56 and current monographs determination of Ninhydrin positive substances and Ammonium

 

Particle Analysis
  • Characterization and quantification of particles for pharmaceutical product according EP 2.9.19, USP 787, 788 as well as 789
  • Qualitative and quantitative analysis of visible particles
  • Quantitative analyses of sub-visible particles beginning from 2 μm
  • Rapid clarification of organic and inorganic material basis and semi quantitative elemental composition

 

Microbiological Analysis
Tests acc. to Ph. Eur.
  • Microbiological Examination of Non-sterile Products: Test for Specified Microorganisms acc. to 2.6.13 only E. coli, Salmonella, P. aeruginosa S. aureus 
  • Microbiological Examination of Non-sterile Products: Microbial Enumeration Tests acc. to 2.6.12
  • Bacterial Endotoxins acc. to 2.6.14 (gel clot method and Kinetic Turbidimetric method
  • Microbiological Assay of Antibiotics acc. to 2.7.2
  • Efficacy of Antimicrobial Preservation acc. to 5.1.3
  • Water, purified (Aqua purificata; Monograph 0008)
  • Water for injection (Monograph 0169)
  • Water for preparation of extracts (Monograph 2249)
Tests acc. to USP
  • Chapter Microbiological Examination of Non-sterile Products: Microbial Enumeration Test
  • Chapter Microbiological Examination of Nonsterile Products: Test for Specified Microorganisms Chapter Antibiotics-Microbial Assay
  • Chapter Bacterial Endotoxins Test
Additional Services e.g. 
  • Product-specific Validations (acc. to Ph. Eur. and USP)
  •  Development and Validation of Rapid Test Methods (e.g. Simplate® especially for biotechnological derived APIs with a maximum sample weight of 100 mg and results)

 

Why to choose us
  • Long term scientific and analytical experience
  • Fast and in time delivery
  • Tailored support to your needs
  • Flexible and high capacities
  • Very Competitive Prices

 

Gerne stehen wir für weitere Fragen zur Verfügung. Wir freuen uns auf Ihre Kontaktaufnahme!

LVA GmbH
Magdeburggasse 10, 3400 Klosterneuburg
Contact Us, set of six white icons in gray boxes +43 2243 26622-4210
Contact Us, set of six white icons in gray boxes

 

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