Formulation-Ready Posaconazole API: Why Particle Size & Purity Matter
Formulation-Ready Posaconazole API: Critical Standards for Particle Size & Purit
Formulation-ready Posaconazole API (CAS 171228-49-2) requires a micronized particle size distribution (PSD) with a D50 of 3–5 µm and purity levels ≥ 99.5%. For B2B procurement, WHO-GMP certification and ICH Q3A/B compliance are essential for ensuring bioavailability and regulatory acceptance in antifungal drug products.
Sourced from WHO-GMP certified manufacturers like Bio-Synth in Hyderabad, high-quality Posaconazole APIs align with global cGMP and regulatory expectations.
In today’s competitive B2B pharmaceutical landscape, formulation-ready Posaconazole API must meet exacting standards of particle size and purity to ensure optimal drug performance. Sourced from WHO-GMP certified manufacturers like Bio-Synth in Hyderabad, high-quality Posaconazole APIs align with global cGMP and regulatory expectations.
Quick Technical Reference:
- Standard Purity: ≥ 99.5%
- Optimized PSD: D50 (3–5 µm)
- Pharmacopeia: In-House / USP / IP Compliant
- Regulatory: DMF, eCTD, WHO-GMP, CEP Readiness
This article explains why particle size distribution (PSD) and purity are critical in antifungal formulations, how API suppliers in India meet these standards, and what procurement teams need to consider when sourcing TB and antifungal APIs from industrial hubs like the Balanagar Industrial Area.
Understanding the Critical Role of Posaconazole API
Posaconazole is a second-generation triazole antifungal agent used globally to treat invasive Aspergillosis and Candida infections. Highly potent and poorly water-soluble, Posaconazole’s performance largely depends on API particle engineering and purity.
Formulators demand tightly controlled particle size and high chemical purity to:
- Enhance bioavailability: Crucial for BCS Class II drugs.
- Ensure uniform dispersion: Vital for oral suspensions.
- Maintain physical and chemical stability: Prevents polymorphic conversion.
- Meet regulatory standards: Ensures first-time-right filings.
Why Particle Size Matters in Formulation-Ready API?
In low-solubility APIs like Posaconazole, solubility and dissolution rate are the limiting factors for bioavailability.
The Science Behind Particle Size Distribution (PSD)
A narrower PSD—typically D10, D50, and D90 values in the 3–10 µm range—can significantly:
- Reduce dosage variability: Ensuring each dose has the same therapeutic effect.
- Enhance absorption in GI tract: Faster dissolution leads to better uptake.
- Minimize sedimentation: Prevents phase separation in liquid formulations.
Key Industry Benchmarks for Posaconazole
| PSD Parameter | Typical Range | Acceptability |
| D10 | 1–2 µm | Ideal for micronized powder |
| D50 (Median) | 3–5 µm | B2B Standard Benchmark |
| D90 | ≤ 10 µm | Mandatory for Content Uniformity |
Purity: A Non-Negotiable Parameter for Global Buyers
Posaconazole API synthesized through multi-step processes may carry starting material residues, genotoxic impurities, or degradation products like Deshydroxy Posaconazole.
Impurity Profile & Regulatory Standards
WHO, USFDA, and EMA stress that APIs must have:
- Total impurities: < 0.5%
- Individual impurities: < 0.1% (per ICH Q3A/B)
- Residual solvents: As per ICH-Q3C standards.
Analytical Controls at Bio-Synth
At the Hyderabad facility, analytical excellence ensures the API exceeds 99.5% purity using:
- HPLC (High-Performance Liquid Chromatography): For purity and assay validation.
- GC (Gas Chromatography): For monitoring residual solvents.
- UV/IR Spectroscopy: For structural identity and identifying unknown impurities.
India’s API Ecosystem: Sourcing from Hyderabad
India is the world’s third-largest API exporter. Key drivers for sourcing from India include strong IP compliance and WHO-GMP, USFDA, and EU-GMP verified facilities.
Hyderabad’s Balanagar Industrial Area: A Strategic Cluster
Located in Telangana, Hyderabad hosts over 300+ active pharma companies. Bio-Synth (established in 1943) operates a WHO-GMP certified campus in Balanagar equipped with micronization units, clean rooms, and QA/QC labs for antifungal and TB API production.
Procurement Insights: What Should B2B Buyers Look For?
| Parameter | Why It’s Critical | Ideal Specification |
| PSD (Micronized) | Bioavailability & content uniformity | D50 ~3–5 µm |
| Chemical Purity | Safety & regulatory acceptance | ≥ 99.5% |
| Impurity Profile | ICH compliance (e.g., Deshydroxy) | < 0.1% per impurity |
| Documentation | Market clearance | eCTD, DMF, CoA, TSE/BSE |
| Supply Consistency | Avoid stock-outs | ≥ 6-month forward stock |
| Buyer Type | Key Concern | Relevant Spec |
| Formulation Scientist | Dissolution | D50 3–5 µm |
| QA/QC Team | Compliance | ICH Q3A/B |
| Regulatory Affairs | Market Filing | DMF, eCTD |
| Procurement | Supply Risk | 6-month stock |
Role of CDMOs & Regulatory Support
Pharma companies often partner with GMP-certified CDMOs in India for tech transfer, comparative bioequivalence optimization, and custom impurity profiling.
Bio-Synth Regulatory Advantage:
- Timely availability of U.S. and EU region CTD modules.
- Expertise in responding to technical queries from authorities.
- Full traceability and audit readiness for global inspections.
Global Market Trends: Leading API Importers
- North America (USA, Canada): High demand for documented purity.
- Southeast Asia (Vietnam, Indonesia): Shifting focus to Indian quality.
- LATAM (Brazil, Mexico): Strong reliance on WHO-GMP certified sources.
- Europe (Germany, UK): Searching for high-purity CDMOs.
Final Thoughts
Looking for formulation-ready Posaconazole API with consistent PSD? Contact Bio-Synth for CoA, DMF, and bulk pricing.
FAQs:
- Why do buyers trust Indian APIs like Posaconazole?
Buyers trust Indian APIs due to WHO-GMP certification, cost-efficiency, and deep expertise in complex molecules. Manufacturers from Hyderabad’s Balanagar hub offer high-purity production at a global scale.
- What is the ideal particle size for formulation-ready Posaconazole API?
Ideally, the D50 value should be in the 3–5 µm range. This ensures the API achieves the dissolution rates necessary for consistent therapeutic absorption.
- Can Bio-Synth support regulatory filings for global markets?
Yes. Bio-Synth provides CTD/eCTD modules, validated analytic data, and DMFs for over 80 countries, meeting both USFDA and WHO-GMP requirements.
- Is micronization mandatory for Posaconazole formulations?
Micronization is not legally mandatory, but it is technically essential for most Posaconazole formulations. Posaconazole is a poorly water-soluble (BCS Class II) antifungal API, where dissolution rate is the primary limiting factor for bioavailability.
- What documents are required to source Posaconazole API for US/EU markets?
To source Posaconazole API for regulated markets such as the US and Europe, buyers typically require a comprehensive regulatory and quality documentation package, including:
- Drug Master File (DMF) – USFDA-compliant, with letter of access
- CTD / eCTD Modules – Quality (Module 3) documentation
- Certificate of Analysis (CoA) – Batch-specific, ICH-compliant
- WHO-GMP Certificate – Issued by a recognized authority
- CEP Readiness / Support – For European market submissions
- ICH Q3A/B Impurity Profile – Including genotoxic impurity assessment
- Residual Solvent Data (ICH Q3C)
- Stability Data – As per ICH guidelines
- TSE/BSE & Declaration of Origin – Where applicable
Post a comment