1. Identification

- FTIR Spectroscopy

Matches reference spectrum

USP ?197? / EP 2.2.24

Conforms to standard

- HPLC Retention Time

Matches reference standard

In-house HPLC method

±2% of reference RT

2. Appearance

White to off-white crystalline powder

Visual inspection

Free from visible impurities

3. Assay (Purity)

98.0% – 102.0%

HPLC (USP ?621?)

Within specified range

4. Water Content

≤0.5% (w/w)

Karl Fischer (USP ?921?)

≤0.5%

5. Residual Solvents

GC (USP ?467?)

- Methanol

≤3000 ppm

Complies with ICH Q3C

- Acetone

≤5000 ppm

6. Heavy Metals

≤10 ppm

ICP-MS (USP ?232?)

≤10 ppm

7. Related Substances

HPLC

- Single impurity

≤0.5%

- Total impurities

≤1.0%

8. Microbial Limits

USP ?61?

- TAMC

≤1000 CFU/g

- TYMC

≤100 CFU/g

9. Particle Size

90% ≤100 μm (if applicable)

Laser diffraction

As per formulation needs

Supply Chain Excellence

? Integrated manufacturing   & QC processes
  ? Strategic partnerships with 100+ certified suppliers
  ? MOQ flexibility (from samples to bulk orders)

Global Compliance

? Certifications: ISO 9001,   CE, FDA, REACH, etc.
  ? Strict adherence to international trade regulations
  ? Eco-friendly packaging options

Technology Edge

? Advanced production   equipment (e.g., CNC/automated lines)
  ? R&D team with 15+ years industry expertise
  ? Custom OEM/ODM solutions

Logistics Efficiency

? 30-day standard   delivery to major ports worldwide
  ? Partnerships with DHL/Maersk/FedEx
  ? Real-time shipment tracking

Customer-Centric Service

? Dedicated multilingual   support team (English/Spanish/Arabic/etc.)
  ? 24/7 pre-sales & after-sales assistance
  ? On-demand technical documentation

Cost Optimization

? Raw material sourcing from   top-tier suppliers
  ? Energy-efficient manufacturing
  ? 5-15% cost advantage vs. competitors

Quality Assurance

? Triple-inspection system   (pre/mid/post-production)
  ? 0.37% avg. defect rate
  ? Lifetime product support

Market Reputation

? Serving 50+   countries since [Year]
  ? Featured clients: [Industry-leading brands]
  ? 98.2% positive feedback rate