MediSoLab The scope of service of our laboratory, which is equipped with the latest technology instrumental analysis devices and designed in accordance with cGMP – GLP, has been determined by considering the needs of the pharmaceutical industry. Our Instrumental Analysis services consist of the following main topics and contents.

Analytical Method Development and Improvement

Analytical method development using the possibilities offered by modern technology is one of our areas of expertise to help you develop fast, reliable, reproducible and time-cost effective methods from the finished product, active and auxiliary raw materials to packaging materials. In addition, by modernizing your existing methods, for example by adapting your HPLC methods to UPLC, you can save time and money significantly.

Analytical Method Validation

Analytical method validation is carried out according to the validation protocol prepared to include the following parameters in line with ICH / FDA principles and varies according to the validation type. The main topics of Analytical Validation are as follows: Selectivity and Specificity Precision Linearity Accuracy Intermediate precision LOD and LOQ Durability Solution stability System suitability Degradation tests

Analytical Method Transfer

The transfer of analytical methods, which were previously made abroad or in another laboratory, in accordance with your laboratory and devices, is done in accordance with ICH / FDA principles and method transfer.

Cleaning Validation

Developing analytical methods (TOC, HPLC, etc.) with the most suitable devices to determine the residue at very low concentrations for the determination of residue amount in Cleaning Validation

Comparative solubility studies (in-vitro dissolution) in Solid Pharmaceutical Dosage Forms (Tablets, Capsules, Suspensions, etc.)

• Performing the dissolution rate test
• Profile studies (f2 and f1 tests)

Permeability tests

• Cream
• Gel
• Performing permeability tests on pomades

Pharmaceutical Active Substance Tests

Crystal structure screening Crystal structure screening in APIs with XRD device

• Crystal structure definition
• crystal size
• crystallinity
• Polymorphic forms
• Morphology

Stereoism analysis (Chiral based active substance analysis)

Qualitative and quantitative analysis of stereoisomers (enantiomers) in raw materials and finished products

Stability Monitoring and Analysis

Long-term stability, intermediate stability, accelerated stability and in-use stability services are provided for the finished product and raw material.

• Long-term stability studies (25 ºC±2 ºC and 60% RH±5 RH humidity conditional)
• Intermediate stability studies (30 ºC±2 ºC and 65% RH±5 RH humidity conditional)
• Accelerated stability studies (45 ºC±2 ºC and 75% RH±5 RH humidity conditional)

For products whose storage condition is Refrigerator and Cold chain products

• Long-term stability studies (5 ºC±3 ºC conditional)
• Accelerated stability studies (25 ºC±2 ºC and 60% RH±5 RH humidity conditional)

Quality control tests

Analyzing drug raw materials and auxiliary substances in accordance with specific methods, EP, USP, BP, JP, CP, IP and other international Pharmacopies,

Raw material tests;

• Determination of activity (potency)
• Determination of active substance
• Impurity analysis
• Residual Solvent Quantification (Residual Solvents)
• pH

Finished product tests:

• Determination of active substance (Assay)
• Impurity analysis
• Residual Solvent Quantification (Residual Solvents)
• Quantification of Preservatives (Antimicrobial and Antioxidant)
• Dissolution rate (Dissolution) / Comparative Profile study
• Permeability / permeability / in-vitro study of topical products
• Antimicrobial efficacy test
• Determination of moisture
• pH
• Intensity
• osmolarity
• Weight deviation
• friability
• Hardness
• Dispersion
• permeability
• Viscosity
• Particle Size Distribution (PSD) 

Our Instrumental Analyzers and related analyzes

HPLC (High-Performance Liquid Chromatography)

Quantification of APIs with different chemical properties, impurity analyzes and preservative analyzes on HPLC devices equipped with different types of detectors such as UV-Visible, PDA (DAD), RF, RID and ELSD)

UHPLC (Ultra High-Performance Liquid Chromatography)

• Analysis of analyzes that take a long time with HPLC to be analyzed in a shorter time and at less cost
• Analysis of Profile and Dissolution rate test analyzes in a short time, which is not possible to analyze with UV-Spectrophotometer

UV-VIS Spectrophotometer

Qualitative and quantitative analysis of raw materials, intermediates and finished products

GC-Head Space / Liquid Injection (Gas Chromatography)

Analysis of volatile solvents, quantification of some active pharmaceutical ingredients and analysis of impurities

Dissolution 

• Rate test in tablets
• Profile studies (f1 and f2 tests)

Franz Diffusion Cell System

Permeability/permeability tests of topical and nasal products