Pharma

Purpose of Drug Analysis

Pharmaceutical analysis involves the scientific testing and evaluation of pharmaceutical products to check their quality, safety and efficacy. These analyses play a critical role in both the manufacturing processes and the approval stages of medicines before they are marketed.

Types of Drug Analysis

A. Chemical Analysis

1. Determination of Active Substance:
   • Determines the amount and purity of the active ingredient in the drug.
   • For example: HPLC, GC-MS, etc.
2. Purity Tests:
   • Detects the presence of unwanted impurities (contaminants) in medicines.
   • Compliance with pharmacopeia standards (USP, EP) is required.
3. pH Analysis:
   • Controls the acidic or basic properties of drugs.
   • It is important for stability and efficiency.
4. Resolution and Dissolution Rate:
   • It is directly related to the bioavailability of the drug.
   • It is a vital test, especially for oral formulations.

B. Physical Analysis

1. Particle Size Distribution:
   • It is a factor affecting the physical homogeneity and performance of the drug.
   • Measured by laser diffraction or microscopy.
2. Tablet and Capsule Tests:
   • Dissolution Time: Measures the time it takes for the drug to dissolve in the gastrointestinal tract.
   • Fracture Strength: The physical strength of the drug is tested.
3. Moisture Content Analysis:
   • It is important for drug stability and protection from microbial contamination.

C. Microbiological Analysis

1. Sterility Test:
   • Checks for the presence of microbial contamination in drugs that should be sterile.
2. BioBurden Analysis:
   • Measures the microbial load of raw materials and products used in pharmaceutical production.
3. Antibacterial and Antifungal Activity Tests:
   • Confirms the efficacy of antibiotics and antifungal drugs.

D. Pharmacokinetics and Bioequivalence Tests

1. Bioavailability:
   • Measures how much and how fast the drug reaches the systemic circulation.
2. Bioequivalence:
   • Confirms that generic medicines provide the same efficacy as the original medicine.

E. Stability Tests

1. Accelerated Stability Test:
   • Measures the drug's resistance to temperature, humidity and light.
   • Used to determine shelf life.
2. Long Term Stability Test:
   • Tests the long-term durability of medicines under specified storage conditions.

F. Toxicological Analyses

1. Acute Toxicity Test:
   • Measures the effects of high doses of the drug.
2. Subchronic and Chronic Toxicity Tests:
   • Examines safety in long-term use.
3. Genotoxicity Tests:
   • Tests whether the drug damages genetic material.

As Nanolab Laboratory Group;
We have started Pharmaceutical analysis in accordance with Pharmacopoeias (USP, EP, JP, BP) and ICH guidelines, in GLP standards, with our expert team. In our laboratory, method validations have been made in order to perform 18 different nitrosamine analyzes at the same time, and we are at your service with our wide analysis portfolio given below.

• Actives and Excipients
• Pharmaceutical Products
• Packaging Analysis
• Method Development and Validations
• Analytical Support for Process Validations
• Analytical Supports for Cleaning Validations
• Analytical Supports for Stability Study
• Transitivity Studies
• Stress Studies
• Water Analysis
• Protective Effectiveness Test,
• Microbial Analysis of Non Sterile Products

Please contact us for more information.